Publikationen

@ARTICLE{stemler2024irsa107161,
  author = {Stemler, J.~ and Yeghiazaryan, L.~ and Stephan, C.~ and Mohn, K.G.-I.~ and Carcas-Sansuan, A.-J.~ and Rodriguez, E.R.~ and Moltó, J.~ and Mitxeltorena, I.V.~ and Welte, T.~ and Zablockienė, B.~ and Akova, M.~ and Bethe, U.~ and Heringer, S.~ and Salmanton-García, J.~ and Jeck, J.~ and Tischmann, L.~ and Zarrouk, M.~ and C{\"u}ppers, A.~ and Biehl, L.M.~ and Grothe, J.~ and Mellinghoff, S.C.~ and Nacov, J.A.~ and Neuhann, J.M.~ and Sprute, R.~ and Frías-Iniesta, J.~ and Negi, R.~ and Gaillard, C.~ and Saini, G.~ and León, A.G.~ and Mallon, P.W.G.~ and Lammens, C.~ and Hotterbeekx, A.~ and Loens, K.~ and Malhotra-Kumar, S.~ and Goossens, H.~ and Kumar-Singh, S.~ and K{\"o}nig, F.~ and Posch, M.~ and Koehler, P.~ and Cornely, O.A.~},
  title = {Immunogenicity, Reactogenicity and Safety of a Second Booster with BNT162b2 or Full-Dose mRNA-1273: A Randomised VACCELERATE Trial in Adults ≥75 Years (EU-COVAT-1-AGED Part B).},
  journal = {International Journal of Infectious Diseases},
  year = {2024},
  volume = {146},
  pages = {107161},
  issn = {1878-3511 1201-9712},
  doi = {10.1016/j.ijid.2024.107161},
  keywords = {SARS-CoV-2;advanced age;anti-RBD IgG;booster vaccination;fourth dose;immunosenescence;neutralising antibodies;variants of concern}
}

@ARTICLE{gewily2024qcps,
  author = {Gewily, M.~ and Plan, E.L.~ and Yousefi, E.~ and K{\"o}nig, F.~ and Posch, M.~ and Hopfner, F.~ and H{\"o}glinger, G.~ and Karlsson, M.O.~},
  title = {Quantitative Comparisons of Progressive Supranuclear Palsy Rating Scale Versions Using Item Response Theory.},
  journal = {Movement Disorders},
  year = {2024},
  issn = {1531-8257 0885-3185},
  doi = {10.1002/mds.30001},
  keywords = {item response theory;progressive supranuclear palsy;progressive supranuclear palsy rating scale}
}

@ARTICLE{burnett2024aeta34473462,
  author = {Burnett, T.~ and K{\"o}nig, F.~ and Jaki, T.~},
  title = {Adding Experimental Treatment Arms to Multi-Arm Multi-Stage Platform Trials in Progress.},
  journal = {Statistics in Medicine},
  year = {2024},
  volume = {43},
  number = {18},
  pages = {3447--3462},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.10090},
  keywords = {adaptive designs;conditional error;design modification;multi‐arm multi‐stage}
}

@ARTICLE{derhaschnig2024ppld102518,
  author = {Derhaschnig, U.~ and Buchtele, N.~ and Steiner, M.M.~ and Drucker, C.~ and Firbas, C.~ and Sch{\"o}rgenhofer, C.~ and Gelbenegger, G.~ and K{\"o}nig, F.~ and Jilma, B.~ and Kovacevic Miljevic, K.D.~},
  title = {Pharmacokinetics and Pharmacodynamics of Low Doses of Recombinant Tissue Plasminogen Activator to Establish a Model for Biosimilarity Comparisons.},
  journal = {Research and Practice in Thrombosis and Haemostasis},
  year = {2024},
  volume = {8},
  number = {6},
  pages = {102518},
  issn = {2475-0379},
  doi = {10.1016/j.rpth.2024.102518},
  keywords = {clinical trial;pharmacokinetics;pharmacodynamics;thrombolytic therapy;tissue plasminogen activator}
}

@ARTICLE{bethe2024iavt,
  author = {Bethe, U.~ and Pana, Z.D.~ and Drosten, C.~ and Goossens, H.~ and K{\"o}nig, F.~ and Marchant, A.~ and Molenberghs, G.~ and Posch, M.~ and Van Damme, P.~ and Cornely, O.A.~},
  title = {Innovative Approaches for Vaccine Trials as a Key Component of Pandemic Preparedness – A White Paper.},
  journal = {Infection},
  year = {2024},
  issn = {1439-0973 0300-8126},
  doi = {10.1007/s15010-024-02347-1},
  keywords = {Bayesian;Prevention;Adaptive platform trial;Concurrent controls;Enrichment;Frequentist;Interpandemic interval;Modelling pandemic preparedness;Randomized clinical trial;Response-adaptive randomization;Simulation;Stakeholders;Trial design;VACCELERATE;Vaccines}
}

@ARTICLE{sena2024naca144,
  author = {Sena, E.~ and Tacke, F.~ and Anstee, Q.M.~ and Di Prospero, N.~ and Skalshøi-Kjær, M.~ and Muñoz-Martínez, S.~ and Rivera-Esteban, J.~ and Jiménez-Masip, A.~ and Bañales, J.M.~ and Martínez-Gómez, M.~ and Koenig, F.~ and Genescà, J.~ and Ratziu, V.~ and Pericàs, J.M.~},
  title = {Needs Assessment for Creation of a Platform Trial Network in Metabolic-Dysfunction Associated Steatohepatitis.},
  journal = {Communications Medicine},
  year = {2024},
  volume = {4},
  pages = {144},
  issn = {2730-664X},
  doi = {10.1038/s43856-024-00560-5}
}

@ARTICLE{nguyen2024ript5263,
  author = {Nguyen, Q.L.~ and Hees, K.~ and Hernandez Penna, S.~ and K{\"o}nig, F.~ and Posch, M.~ and Bofill Roig, M.~ and Meyer, E.L.~ and Freitag, M.M.~ and Parke, T.~ and Otte, M.~ and Dauben, H.-P.~ and Mielke, T.~ and Spiertz, C.~ and Mesenbrink, P.~ and Gidh-Jain, M.~ and Pierre, S.~ and Morello, S.~ and Hofner, B.~},
  title = {Regulatory Issues of Platform Trials: Learnings from EU-PEARL.},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2024},
  volume = {116},
  number = {1},
  pages = {52--63},
  issn = {1532-6535 0009-9236},
  doi = {10.1002/cpt.3244}
}

@ARTICLE{bardo2024mnhc10691092,
  author = {Bardo, M.~ and Huber, C.~ and Benda, N.~ and Brugger, J.~ and Fellinger, T.~ and Galaune, V.~ and Heinz, J.~ and Heinzl, H.~ and Hooker, A.C.~ and Klinglm{\"u}ller, F.~ and K{\"o}nig, F.~ and Mathes, T.~ and Mittlb{\"o}ck, M.~ and Posch, M.~ and Ristl, R.~ and Friede, T.~},
  title = {Methods for Non-Proportional Hazards in Clinical Trials: A Systematic Review.},
  journal = {Statistical Methods in Medical Research},
  year = {2024},
  volume = {33},
  number = {6},
  pages = {1069--1092},
  issn = {1477-0334 0962-2802},
  doi = {10.1177/09622802241242325},
  keywords = {survival analysis;log-rank test;non-proportional hazards;Cox model;right-censored observations}
}

@ARTICLE{ristl2024sipc589610,
  author = {Ristl, R.~ and G{\"o}tte, H.~ and Sch{\"u}ler, A.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {Simultaneous Inference Procedures for the Comparison of Multiple Characteristics of Two Survival Functions.},
  journal = {Statistical Methods in Medical Research},
  year = {2024},
  volume = {33},
  number = {4},
  pages = {589--610},
  issn = {1477-0334 0962-2802},
  doi = {10.1177/09622802241231497},
  keywords = {multiple testing;Survival analysis;non-proportional hazards;randomized clinical trial;simultaneous inference}
}

@ARTICLE{gidhjain2024dgtt204,
  author = {Gidh-Jain, M.~ and Parke, T.~ and K{\"o}nig, F.~ and Spiertz, C.~ and Mesenbrink, P.~},
  title = {Developing Generic Templates to Shape the Future for Conducting Integrated Research Platform Trials.},
  journal = {Trials},
  year = {2024},
  volume = {25},
  pages = {204},
  issn = {1745-6215},
  doi = {10.1186/s13063-024-08034-8},
  keywords = {Humans;*Research Design;EU Patient-cEntric clinicAl tRial pLatforms;Integrated research platform trials;Master Protocol Template}
}

@ARTICLE{danielfischer2024cpri478481,
  author = {Daniel-Fischer, L.~ and Antlanger, M.~ and Cejka, D.~ and Eller, K.~ and Gauckler, P.~ and Odler, B.~ and Rudnicki, M.~ and S{\"a}emann, M.D.~ and Schmidt, A.~ and Sunder-Plassmann, G.~ and Wiesholzer, M.~ and Windpessl, M.~ and Zitt, E.~ and Koenig, F.~ and Greenbaum, L.A.~ and Kronbichler, A.~ and Aufricht, C.~},
  title = {Clopidogrel for Proteinuria Reduction in Focal Segmental Glomerulosclerosis: Phase 2 Trial Design.},
  journal = {Kidney International Reports},
  year = {2024},
  volume = {9},
  number = {2},
  pages = {478--481},
  issn = {2468-0249},
  doi = {10.1016/j.ekir.2023.10.027},
  keywords = {clopidogrel;proteinuria;drug repurposing;FSGS}
}

@ARTICLE{bofillroig2024actd237252,
  author = {Bofill Roig, M.~ and Gómez Melis, G.~ and Posch, M.~ and Koenig, F.~},
  title = {Adaptive Clinical Trial Designs with Blinded Selection of Binary Composite Endpoints and Sample Size Reassessment.},
  journal = {Biostatistics},
  year = {2024},
  volume = {25},
  number = {1},
  pages = {237--252},
  issn = {1468-4357 1465-4644},
  doi = {10.1093/biostatistics/kxac040},
  keywords = {Adaptive design;Interim analysis;Clinical trial;Composite endpoint;Sample size}
}

@ARTICLE{koenig2024csgp102384,
  author = {Koenig, F.~ and Spiertz, C.~ and Millar, D.~ and Rodríguez-Navarro, S.~ and Machín, N.~ and Van Dessel, A.~ and Genescà, J.~ and Pericàs, J.~ and Posch, M.~ and {EU PEARL Consortium}},
  title = {Current State-of-the-Art and Gaps in Platform Trials: 10 Things You Should Know, Insights from EU-PEARL.},
  journal = {eClinicalMedicine},
  year = {2024},
  volume = {67},
  pages = {102384},
  issn = {2589-5370},
  doi = {10.1016/j.eclinm.2023.102384}
}

@MISC{yousefi2023emtt,
  author = {Yousefi, E.~ and Gewily, M.~ and K{\"o}nig, F.~ and H{\"o}glinger, G.~ and Hopfner, F.~ and Karlsson, M.O.~ and Ristl, R.~ and Zehetmayer, S.~ and Posch, M.~},
  title = {Efficiency of Multivariate Tests in Trials in Progressive Supranuclear Palsy.},
  year = {2023},
  url = {https://arxiv.org/abs/2312.08169}
}

@ARTICLE{neuhann2023iraf71667175,
  author = {Neuhann, J.M.~ and Stemler, J.~ and Carcas, A.J.~ and Frías-Iniesta, J.~ and Akova, M.~ and Bethe, U.~ and Heringer, S.~ and Salmanton-García, J.~ and Tischmann, L.~ and Zarrouk, M.~ and C{\"u}ppers, A.~ and Grothe, J.~ and Leon, A.G.~ and Mallon, P.~ and Negi, R.~ and Gaillard, C.~ and Saini, G.~ and Lammens, C.~ and Hotterbeekx, A.~ and Loens, K.~ and Malhotra-Kumar, S.~ and Goossens, H.~ and Kumar-Singh, S.~ and K{\"o}nig, F.~ and Yeghiazaryan, L.~ and Posch, M.~ and Koehler, P.~ and Cornely, O.A.~},
  title = {Immunogenicity and Reactogenicity of a First Booster with BNT162b2 or Full-Dose mRNA-1273: A Randomised VACCELERATE Trial in Adults ≥75 Years (EU-COVAT-1).},
  journal = {Vaccine},
  year = {2023},
  volume = {41},
  number = {48},
  pages = {7166--7175},
  issn = {1873-2518 0264-410X},
  doi = {10.1016/j.vaccine.2023.10.029},
  keywords = {Adult;Humans;Aged;RNA;Messenger;SARS-CoV-2;Advanced age;Variants of concern;Antibodies;Viral;Immunoglobulin G;*2019-nCoV Vaccine mRNA-1273;*BNT162 Vaccine;Anti-RBD IgG;Antibodies;Neutralizing;COVID-19 Vaccines/adverse effects;Immunogenicity;Vaccine;Neutralising antibodies;Third dose}
}

@ARTICLE{meyer2023smts101515,
  author = {Meyer, E.L.~ and Mielke, T.~ and Parke, T.~ and Jacko, P.~ and Koenig, F.~},
  title = {SIMPLE—A Modular Tool for Simulating Complex Platform Trials.},
  journal = {SoftwareX},
  year = {2023},
  volume = {23},
  pages = {101515},
  doi = {10.1016/j.softx.2023.101515},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85170644139\&doi=10.1016%2fj.softx.2023.101515\&partnerID=40\&md5=3e8a38ebb89a8a8c0bb3172959d13aa9}
}

@ARTICLE{robertson2023oerc24752495,
  author = {Robertson, D.S.~ and Wason, J.M.S.~ and K{\"o}nig, F.~ and Posch, M.~ and Jaki, T.~},
  title = {Online Error Rate Control for Platform Trials.},
  journal = {Statistics in Medicine},
  year = {2023},
  volume = {42},
  number = {14},
  pages = {2475--2495},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.9733},
  keywords = {Humans;Data Interpretation;Statistical;*Research Design;Computer Simulation;multiple testing;platform trial;online hypothesis testing;type I error rate}
}

@ARTICLE{bofillroig2023uncp408,
  author = {Bofill Roig, M.~ and Burgwinkel, C.~ and Garczarek, U.~ and Koenig, F.~ and Posch, M.~ and Nguyen, Q.~ and Hees, K.~},
  title = {On the Use of Non-Concurrent Controls in Platform Trials: A Scoping Review.},
  journal = {Trials},
  year = {2023},
  volume = {24},
  pages = {408},
  issn = {1745-6215},
  doi = {10.1186/s13063-023-07398-7},
  keywords = {Humans;Bias;Randomized Controlled Trials as Topic;*Bayes Theorem;Non-concurrent controls;Platform trials;External controls}
}

@ARTICLE{pericàs2023lsiis819s819,
  author = {Pericàs, J.M.~ and de Sena, E.~ and Tacke, F.~ and Anstee, Q.~ and Di Prospero, N.~ and Kjaer, M.~ and Mesenbrink, P.~ and Koenig, F.~ and Genescà, J.~ and Ratziu, V.~ and Martínez, S.M.~},
  title = {Lessons for the Setting of an International Integrated Research Platform to Conduct Adaptive Trials in Non-Alcoholic Steatohepatitis: Results of the EU-PEARL Project.},
  journal = {Journal of Hepatology},
  year = {2023},
  volume = {78},
  number = {Suppl 1: Abstract Book of EASL 2023 Congress, Vienna, Austria, 21–24 June 2023},
  pages = {S819},
  issn = {0168-8278},
  doi = {10.1016/S0168-8278(23)02281-X},
  url = {https://doi.org/10.1016/S0168-8278(23)02281-X}
}

@ARTICLE{singer2023ahrw600,
  author = {Singer, C.~ and K{\"o}nig, F.~ and Kacerovsky-Strobl, S.~ and Danzinger, S.~ and Brunner, C.~ and Suppan, C.~ and Deutschmann, C.~ and Balic, M.~ and Greil, R.~ and Egle, D.~ and De Azambuja, E.~ and Di Cosimo, S.~ and Gnant, M.~},
  title = {Association of HER2/CEP17 Ratio with pCR after HER2-Directed Neoadjuvant Treatments in the Phase III NeoALTTO Trial.},
  journal = {Journal of Clinical Oncology},
  year = {2023},
  volume = {41},
  number = {16, Suppl: Abstracts Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL, 2–6 June 2023},
  pages = {600},
  issn = {0732-183X},
  url = {https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2023.41.16_suppl.600}
}

@ARTICLE{posch2023tirh310311,
  author = {Posch, M.~ and Ristl, R.~ and K{\"o}nig, F.~},
  title = {Testing and Interpreting the “Right” Hypothesis—Comment on “Non-proportional Hazards — An Evaluation of the MaxCombo Test in Cancer Clinical Trials”.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2023},
  volume = {15},
  number = {2},
  pages = {310--311},
  doi = {10.1080/19466315.2022.2090431},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85135843254\&doi=10.1080%2f19466315.2022.2090431\&partnerID=40\&md5=70a4eb94156252057b9fea63e58ff6b4}
}

@ARTICLE{pericàs2023ranm948961,
  author = {Pericàs, J.M.~ and Di Prospero, N.A.~ and Anstee, Q.M.~ and Mesenbrinck, P.~ and Kjær, M.S.~ and Rivera-Esteban, J.~ and Koenig, F.~ and Sena, E.~ and Pais, R.~ and Manzano, R.~ and Genescà, J.~ and Tacke, F.~ and Ratziu, V.~ and {the EU-PEARL NASH Investigators}},
  title = {Review Article: The Need for More Efficient and Patient-Oriented Drug Development Pathways in NASH—Setting the Scene for Platform Trials.},
  journal = {Alimentary Pharmacology \& Therapeutics},
  year = {2023},
  volume = {57},
  number = {9},
  pages = {948--961},
  issn = {0269-2813},
  doi = {10.1111/apt.17456},
  url = {https://doi.org/10.1111/apt.17456},
  keywords = {drug development;endpoints;platform trials;master protocols;non-alcoholic steatohepatitis;study designs}
}

@ARTICLE{meyer2023iraq101347,
  author = {Meyer, E.L.~ and Kumaus, C.~ and Majka, M.~ and Koenig, F.~},
  title = {An Interactive R-Shiny App for Quickly Visualizing a Tidy, Long Dataset with Multiple Dimensions with an Application in Clinical Trial Simulations for Platform Trials.},
  journal = {SoftwareX},
  year = {2023},
  volume = {22},
  pages = {101347},
  doi = {10.1016/j.softx.2023.101347},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85150923753\&doi=10.1016%2fj.softx.2023.101347\&partnerID=40\&md5=29fcb7c6bd3e655dadf05f941fc0b47a}
}

@ARTICLE{haupenthal2023ampa213,
  author = {Haupenthal, F.~ and Rahn, J.~ and Maggi, F.~ and Gelas, F.~ and Bourgeois, P.~ and Hugo, C.~ and Jilma, B.~ and B{\"o}hmig, G.A.~ and Herkner, H.~ and Wolzt, M.~ and Doberer, K.~ and Vossen, M.~ and Focosi, D.~ and Neuwirt, H.~ and Banas, M.~ and Banas, B.~ and Budde, K.~ and Viklicky, O.~ and Malvezzi, P.~ and Rostaing, L.~ and Rotmans, J.I.~ and Bakker, S.J.L.~ and Eller, K.~ and Cejka, D.~ and Pérez, A.M.~ and Rodriguez-Arias, D.~ and K{\"o}nig, F.~ and Bond, G.~},
  title = {A Multicentre, Patient- and Assessor-Blinded, Non-Inferiority, Randomised and Controlled Phase II Trial to Compare Standard and Torque Teno Virus-Guided Immunosuppression in Kidney Transplant Recipients in the First Year after Transplantation: TTVguideIT.},
  journal = {Trials},
  year = {2023},
  volume = {24},
  pages = {213},
  issn = {1745-6215},
  doi = {10.1186/s13063-023-07216-0},
  keywords = {Adult;Humans;Quality of Life;Kidney transplantation;Immunosuppression;Torque teno virus;Infection;*Kidney Transplantation/adverse effects;*Torque teno virus;Graft rejection;Graft Rejection/diagnosis/prevention \& control;Immunological monitoring;Immunosuppression Therapy;Immunosuppressive Agents/adverse effects;Personalised medicine;Tacrolimus;Tacrolimus/adverse effects}
}

@ARTICLE{ay2023vwfa11471158,
  author = {Ay, C.~ and Kovacevic, K.D.~ and Kraemmer, D.~ and Schoergenhofer, C.~ and Gelbenegger, G.~ and Firbas, C.~ and Quehenberger, P.~ and Jilma-Stohlawetz, P.~ and Gilbert, J.C.~ and Zhu, S.~ and Beliveau, M.~ and Koenig, F.~ and Iorio, A.~ and Jilma, B.~ and Derhaschnig, U.~ and Pabinger, I.~},
  title = {The von Willebrand Factor-Binding Aptamer Rondaptivon Pegol as a Treatment for Severe and Nonsevere Hemophilia A.},
  journal = {Blood},
  year = {2023},
  volume = {141},
  number = {10},
  pages = {1147--1158},
  issn = {1528-0020 0006-4971},
  doi = {10.1182/blood.2022016571},
  keywords = {Adult;Female;Humans;Young Adult;Middle Aged;Half-Life;Factor VIII;*Hemophilia A/drug therapy;*Hemostatics/therapeutic use;von Willebrand Factor/therapeutic use}
}

@ARTICLE{meyer2023dep2e0281674,
  author = {Meyer, E.L.~ and Mesenbrink, P.~ and Di Prospero, N.A.~ and Pericàs, J.M.~ and Glimm, E.~ and Ratziu, V.~ and Sena, E.~ and K{\"o}nig, F.~},
  title = {Designing an Exploratory Phase 2b Platform Trial in NASH with Correlated, Co-Primary Binary Endpoints.},
  journal = {PLoS One},
  year = {2023},
  volume = {18},
  number = {3},
  pages = {e0281674},
  doi = {10.1371/journal.pone.0281674},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85150001407\&doi=10.1371%2fjournal.pone.0281674\&partnerID=40\&md5=503f62666d12f7512c40a8360a8fbda0}
}

@ARTICLE{pericàs2023ptto442447,
  author = {Pericàs, J.M.~ and Tacke, F.~ and Anstee, Q.M.~ and Di Prospero, N.A.~ and Skalshøj Kjær, M.~ and Mesenbrink, P.~ and Koenig, F.~ and Genescà, J.~ and Ratziu, V.~ and {EU-PEARL NASH Investigators}},
  title = {Platform Trials to Overcome Major Shortcomings of Traditional Clinical Trials in Non-Alcoholic Steatohepatitis? Pros and Cons.},
  journal = {Journal of Hepatology},
  year = {2023},
  volume = {78},
  number = {2},
  pages = {442--447},
  issn = {1600-0641 0168-8278},
  doi = {10.1016/j.jhep.2022.09.021},
  keywords = {drug development;platform trials;master protocols;non-alcoholic fatty liver disease;non-alcoholic steatohepatitis;non-invasive biomarkers}
}

@ARTICLE{aljalali2023ppsh7787,
  author = {Al Jalali, V.~ and Bauer, M.~ and W{\"o}lfl-Duchek, M.~ and Sarhan, M.~ and Wicha, S.G.~ and Poschner, S.~ and J{\"a}ger, W.~ and K{\"o}nig, F.~ and Male, C.~ and Zeitlinger, M.~},
  title = {Pilot Pharmacokinetic Study in Healthy Adults Using Intravascular Microdialysis Catheters Modified for Use in Paediatric Patients to Assess Vancomycin Blood Levels.},
  journal = {Clinical Pharmacokinetics},
  year = {2023},
  volume = {62},
  number = {1},
  pages = {77--87},
  issn = {1179-1926 0312-5963},
  doi = {10.1007/s40262-022-01190-7}
}

@ARTICLE{zehetmayer2022ocfd24702485,
  author = {Zehetmayer, S.~ and Posch, M.~ and Koenig, F.~},
  title = {Online Control of the False Discovery Rate in Group-Sequential Platform Trials.},
  journal = {Statistical Methods in Medical Research},
  year = {2022},
  volume = {31},
  number = {12},
  pages = {2470--2485},
  doi = {10.1177/09622802221129051}
}

@ARTICLE{karolyi2022earm883891,
  author = {Karolyi, M.~ and Kaltenegger, L.~ and Pawelka, E.~ and Kuran, A.~ and Platzer, M.~ and Totschnig, D.~ and Koenig, F.~ and Hoepler, W.~ and Laferl, H.~ and Omid, S.~ and Seitz, T.~ and Traugott, M.~ and Arthofer, S.~ and Erlbeck, L.~ and Jaeger, S.~ and Kettenbach, A.~ and Assinger, A.~ and Wenisch, C.~ and Zoufaly, A.~},
  title = {Early Administration of Remdesivir May Reduce Mortality in Hospitalized COVID-19 Patients: A Propensity Score Matched Analysis.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2022},
  volume = {134},
  number = {23-24},
  pages = {883--891},
  issn = {1613-7671 0043-5325},
  doi = {10.1007/s00508-022-02098-9},
  keywords = {Austria;Gender differences;In-hospital mortality;Length of stay;Within 7 days}
}

@ARTICLE{reindlschwaighofer2022srsc20117,
  author = {Reindl-Schwaighofer, R.~ and H{\"o}dlmoser, S.~ and Domenig, O.~ and Krenn, K.~ and Eskandary, F.~ and Krenn, S.~ and Sch{\"o}rgenhofer, C.~ and Rumpf, B.~ and Karolyi, M.~ and Traugott, M.T.~ and Abrahamowicz, A.~ and Tinhof, V.~ and Mayfurth, H.~ and Rathkolb, V.~ and Mußnig, S.~ and Schm{\"o}lz, L.~ and Ullrich, R.~ and Heinzel, A.~ and K{\"o}nig, F.~ and Binder, C.~ and Bonderman, D.~ and Strassl, R.~ and Puchhammer-St{\"o}ckl, E.~ and Gorkiewicz, G.~ and Aberle, J.H.~ and Jilma, B.~ and Wenisch, C.~ and Poglitsch, M.~ and Oberbauer, R.~ and Zoufaly, A.~ and Hecking, M.~},
  title = {The Systemic Renin-Angiotensin System in COVID-19.},
  journal = {Scientific Reports},
  year = {2022},
  volume = {12},
  pages = {20117},
  issn = {2045-2322},
  doi = {10.1038/s41598-022-24628-1},
  keywords = {Humans;Angiotensin II;Renin-Angiotensin System;*COVID-19;SARS-CoV-2;*Peptide Hormones;Angiotensin I;Angiotensin-Converting Enzyme 2;Antihypertensive Agents;Renin}
}

@ARTICLE{bergmann2022cpsg30863092,
  author = {Bergmann, F.~ and Wulkersdorfer, B.~ and Oesterreicher, Z.~ and Bauer, M.~ and Al Jalali, V.~ and Nussbaumer-Pr{\"o}ll, A.~ and W{\"o}lfl-Duchek, M.~ and Jorda, A.~ and Lackner, E.~ and Reiter, B.~ and Stimpfl, T.~ and Ballarini, N.~ and K{\"o}nig, F.~ and Zeitlinger, M.~},
  title = {Comparison of Pharmacokinetics and Stability of Generics of Cefepime, Linezolid and Piperacillin/Tazobactam with Their Respective Originator Drugs: An Intravenous Bioequivalence Study in Healthy Volunteers.},
  journal = {Journal of Antimicrobial Chemotherapy},
  year = {2022},
  volume = {77},
  number = {11},
  pages = {3086--3092},
  issn = {1460-2091 0305-7453},
  doi = {10.1093/jac/dkac285}
}

@ARTICLE{karonitsch2022ttiie002525,
  author = {Karonitsch, T.~ and Yeghiazaryan, L.~ and Lackner, A.~ and Brezinsek, H.P.~ and Stamm, T.A.~ and K{\"o}nig, F.~ and Aletaha, D.~ and Smolen, J.S.~},
  title = {Targeting Type I Interferon (IFN) Signalling in Patients with RA with a High Type I IFN Gene Signature.},
  journal = {RMD Open},
  year = {2022},
  volume = {8},
  number = {2},
  pages = {e002525},
  issn = {2056-5933},
  doi = {10.1136/rmdopen-2022-002525},
  keywords = {Therapeutics;Arthritis;Rheumatoid;Biological Therapy}
}

@ARTICLE{neuhann2022amp2865,
  author = {Neuhann, J.M.~ and Stemler, J.~ and Carcas, A.~ and Frías-Iniesta, J.~ and Bethe, U.~ and Heringer, S.~ and Tischmann, L.~ and Zarrouk, M.~ and C{\"u}ppers, A.~ and K{\"o}nig, F.~ and Posch, M.~ and Cornely, O.A.~},
  title = {A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines in Adults ≥75 Already Vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): A Trial Conducted within the VACCELERATE Network.},
  journal = {Trials},
  year = {2022},
  volume = {23},
  pages = {865},
  issn = {1745-6215},
  doi = {10.1186/s13063-022-06791-y},
  keywords = {SARS-CoV-2;≥75 years;Advanced age;BNT162b2 (Comirnaty®);Booster;COVID-19 vaccination;Fourth dose;Immunosenescence;mRNA-1273 (Spikevax®);Phase II;Randomisation;Variants of concern;VOC}
}

@ARTICLE{bofillroig2022ctat502503,
  author = {Bofill Roig, M.~ and K{\"o}nig, F.~ and Meyer, E.~ and Posch, M.~},
  title = {Commentary: Two Approaches to Analyze Platform Trials Incorporating Non-Concurrent Controls with a Common Assumption.},
  journal = {Clinical Trials},
  year = {2022},
  volume = {19},
  number = {5},
  pages = {502--503},
  issn = {1740-7753 1740-7745},
  doi = {10.1177/17407745221112016}
}

@ARTICLE{ressler2022etnts907s907,
  author = {Ressler, J.M.~ and Kusienicka, A.~ and Silmbrod, R.~ and Silly, T.~ and Bachmayr, V.~ and Plaschka, M.~ and Shaw, L.E.~ and Zila, N.~ and Stepan, A.~ and Tschandl, P.~ and Tittes, J.~ and Roka, F.~ and Haslik, W.~ and Koenig, F.~ and Kunstfeld, R.~ and Petzelbauer, P.~ and Halbritter, F.~ and Weninger, W.~ and Farlik, M.~ and Hoeller, C.~},
  title = {Efficacy and Tolerability of Neoadjuvant Treatment with T-VEC in Difficult to Resect Primary Basal Cell Carcinoma: A Phase II Clinical Trial (NeoBCC).},
  journal = {Annals of Oncology},
  year = {2022},
  volume = {33},
  number = {Suppl 7: Abstract Book of the ESMO Congress 2022, Paris, France, 9–13 September 2022},
  pages = {S907},
  issn = {0923-7534},
  doi = {10.1016/j.annonc.2022.07.920},
  url = {https://www.sciencedirect.com/science/article/pii/S0923753422027715}
}

@ARTICLE{bofillroig2022mtta228,
  author = {Bofill Roig, M.~ and Krotka, P.~ and Burman, C.-F.~ and Glimm, E.~ and Gold, S.M.~ and Hees, K.~ and Jacko, P.~ and Koenig, F.~ and Magirr, D.~ and Mesenbrink, P.~ and Viele, K.~ and Posch, M.~},
  title = {On Model-Based Time Trend Adjustments in Platform Trials with Non-Concurrent Controls.},
  journal = {BMC Medical Research Methodology},
  year = {2022},
  volume = {22},
  pages = {228},
  issn = {1471-2288},
  doi = {10.1186/s12874-022-01683-w},
  keywords = {Humans;Bias;*Sample Size;Adding arms;Non-concurrent controls;Platform trials}
}

@ARTICLE{karolyi2022cmvl870493,
  author = {Karolyi, M.~ and Pawelka, E.~ and Omid, S.~ and Koenig, F.~ and Kauer, V.~ and Rumpf, B.~ and Hoepler, W.~ and Kuran, A.~ and Laferl, H.~ and Seitz, T.~ and Traugott, M.~ and Rathkolb, V.~ and Mueller, M.~ and Abrahamowicz, A.~ and Schoergenhofer, C.~ and Hecking, M.~ and Assinger, A.~ and Wenisch, C.~ and Zeitlinger, M.~ and Jilma, B.~ and Zoufaly, A.~},
  title = {Camostat Mesylate versus Lopinavir/Ritonavir in Hospitalized Patients with COVID-19-Results from a Randomized, Controlled, Open Label, Platform Trial (ACOVACT).},
  journal = {Frontiers in Pharmacology},
  year = {2022},
  volume = {13},
  pages = {870493},
  issn = {1663-9812},
  doi = {10.3389/fphar.2022.870493},
  keywords = {mortality;SARS-CoV-2;ACOVACT;camostat mesylate;high-dose lopinavir/ritonavir;tmprss2;WHO scale}
}

@ARTICLE{frommlet2022spbge0269369,
  author = {Frommlet, F.~ and Szulc, P.~ and K{\"o}nig, F.~ and Bogdan, M.~},
  title = {Selecting Predictive Biomarkers from Genomic Data.},
  journal = {PLoS One},
  year = {2022},
  volume = {17},
  number = {6},
  pages = {e0269369},
  issn = {1932-6203},
  doi = {10.1371/journal.pone.0269369}
}

@ARTICLE{oviedoflores2022ppapi488i489,
  author = {Oviedo Flores, K.A.~ and Kaltenegger, L.~ and Eibensteiner, F.~ and Unterwurzacher, M.~ and Kratochwill, K.~ and Aufricht, C.~ and K{\"o}nig, F.~ and Vychytil, A.~},
  title = {Predictive Parameters of Automated PD Cycler Software for Diagnosis of Catheter Dysfunction.},
  journal = {Nephrology Dialysis Transplantation},
  year = {2022},
  volume = {37},
  number = {Suppl 3: Abstracts 59th ERA Congress, Paris \& Virtual, 19–22 May 2022},
  pages = {i488--i489},
  issn = {0931-0509},
  url = {https://academic.oup.com/ndt/issue-pdf/37/Supplement_3/43533872#page=494}
}

@ARTICLE{eibensteiner2022pmdci496i497,
  author = {Eibensteiner, F.~ and Flores, K.~ and Unterwurzacher, M.~ and Herzog, R.~ and Kratochwill, K.~ and Aufricht, C.~ and Koenig, F.~ and Vychytil, A.~},
  title = {Peritonitis May Disrupt Cyclic Periodicity of Ultrafiltration in Peritoneal Dialysis.},
  journal = {Nephrology Dialysis Transplantation},
  year = {2022},
  volume = {37},
  number = {Suppl 3: Abstracts 59th European Renal Association (ERA) Congress, Paris, France \& Virtual, 19–22 May 2022},
  pages = {i496--i497},
  issn = {0931-0509},
  doi = {https://doi.org/10.1093/ndt/gfac078.016}
}

@ARTICLE{meyer2022dric671690,
  author = {Meyer, E.L.~ and Mesenbrink, P.~ and Dunger-Baldauf, C.~ and Glimm, E.~ and Li, Y.~ and K{\"o}nig, F.~},
  title = {Decision Rules for Identifying Combination Therapies in Open-Entry, Randomized Controlled Platform Trials.},
  journal = {Pharmaceutical Statistics},
  year = {2022},
  volume = {21},
  number = {3},
  pages = {671--690},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.2194},
  keywords = {adaptive trials;clinical trial simulation;combination therapy;platform trials}
}

@ARTICLE{oviedoflores2022amcd5657,
  author = {Oviedo Flores, K.~ and Kaltenegger, L.~ and Eibensteiner, F.~ and Unterwurzacher, M.~ and Kratochwill, K.~ and Aufricht, C.~ and K{\"o}nig, F.~ and Vychytil, A.~},
  title = {Assessing Mechanical Catheter Dysfunction in Automated Tidal Peritoneal Dialysis Using Cycler Software: A Case Control, Proof-of-Concept Study.},
  journal = {Scientific Reports},
  year = {2022},
  volume = {12},
  pages = {5657},
  note = {
[Erratum: Oviedo Flores K., Kaltenegger L., Eibensteiner F., Unterwurzacher M., Kratochwill K., Aufricht C., K{\"o}nig F., Vychytil A. Publisher Correction: Assessing Mechanical Catheter Dysfunction in Automated Tidal Peritoneal Dialysis Using Cycler Software: A Case Control, Proof-of-Concept Study. Scientific Reports 12:7623, (2022)]},
  issn = {2045-2322},
  doi = {10.1038/s41598-022-09462-9}
}

@ARTICLE{brunnerziegler2022pias596601,
  author = {Brunner-Ziegler, S.~ and Spath, T.~ and Kornek, G.~ and K{\"o}nig, F.~ and Parschalk, B.~ and Schnetzinger, M.~ and Straßl, R.P.~ and Savic, R.~ and Foit, A.~ and Resch, H.~ and Thalhammer, F.~},
  title = {Postvaccination Infections among Staff of a Tertiary Care Hospital after Vaccination with Severe Acute Respiratory Syndrome Coronavirus 2 vector and mRNA-Based Vaccines.},
  journal = {Clinical Microbiology and Infection},
  year = {2022},
  volume = {28},
  number = {4},
  pages = {596--601},
  issn = {1469-0691 1198-743X},
  doi = {10.1016/j.cmi.2021.11.023}
}

@ARTICLE{ghosh2022rgsd343360,
  author = {Ghosh, P.~ and Ristl, R.~ and K{\"o}nig, F.~ and Posch, M.~ and Jennison, C.~ and G{\"o}tte, H.~ and Sch{\"u}ler, A.~ and Mehta, C.~},
  title = {Robust Group Sequential Designs for Trials with Survival Endpoints and Delayed Response.},
  journal = {Biometrical Journal},
  year = {2022},
  volume = {64},
  number = {2},
  pages = {343--360},
  doi = {10.1002/bimj.202000169},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85121485738\&doi=10.1002%2fbimj.202000169\&partnerID=40\&md5=ae2e9e40365e7973f3f31e24688bc814}
}

@ARTICLE{eibensteiner2022mdua107110,
  author = {Eibensteiner, F.~ and Oviedo Flores, K.~ and Unterwurzacher, M.~ and Herzog, R.~ and Kratochwill, K.~ and Alper, S.L.~ and Aufricht, C.~ and K{\"o}nig, F.~ and Vychytil, A.~},
  title = {Monitoring Daily Ultrafiltration in Automated Peritoneal Dialysis.},
  journal = {Clinical Journal of the American Society of Nephrology},
  year = {2022},
  volume = {17},
  number = {1},
  pages = {107--110},
  issn = {1555-905X 1555-9041},
  doi = {10.2215/CJN.08180621},
  keywords = {chronic dialysis;peritoneal dialysis;peritoneal membrane;ultrafiltration}
}

@ARTICLE{pawelka2021cinj907916,
  author = {Pawelka, E.~ and Karolyi, M.~ and Mader, T.~ and Omid, S.~ and Kelani, H.~ and Baumgartner, S.~ and Ely, S.~ and Hoepler, W.~ and Jilma, B.~ and Koenig, F.~ and Laferl, H.~ and Traugott, M.~ and Turner, M.~ and Seitz, T.~ and Wenisch, C.~ and Zoufaly, A.~},
  title = {COVID-19 Is Not “Just Another Flu”: A Real-Life Comparison of Severe COVID-19 and Influenza in Hospitalized Patients in Vienna, Austria.},
  journal = {Infection},
  year = {2021},
  volume = {49},
  number = {5},
  pages = {907--916},
  note = {
[Erratum: Pawelka E., Karolyi M., Mader T., Omid S., Kelani H., Baumgartner S., Ely S., Hoepler W., Jilma B., Koenig F., Laferl H., Traugott M., Turner M., Seitz T., Wenisch C., Zoufaly A. Correction to: COVID-19 is Not “Just Another Flu”: A Real-Life Comparison of Severe COVID-19 and Influenza in Hospitalized Patients in Vienna, Austria. Infection 49(5), 917 (2021)]},
  issn = {1439-0973 0300-8126},
  doi = {10.1007/s15010-021-01610-z},
  keywords = {Austria;Mortality;COVID-19;SARS-CoV-2;Comparison;In-hospital;Influenza}
}

@ARTICLE{haupenthal2021tgia44,
  author = {Haupenthal, F.~ and Neuwirt, H.~ and Eller, K.~ and Cejka, D.~ and Banas, B.~ and Budde, K.~ and Rotmans, J.~ and Rostaing, L.~ and Malvezzi, P.~ and Bakker, S.~ and Viklicky, O.~ and Beneyto, I.~ and Ohlmann, S.~ and Bourgeois, P.~ and Del Alamo, M.~ and Navarro, D.~ and Rodriguez-Arias, D.~ and Maggi, F.~ and Graehlert, X.~ and Puchhammer-Stoeckl, E.~ and Regele, H.~ and Vossen, M.~ and Boehmig, G.~ and Wolzt, M.~ and Jilma, B.~ and Herkner, H.~ and Koenig, F.~ and Hugo, C.~ and Bond, G.~},
  title = {TTV Guide IT – A Randomised Controlled Trial to Compare the Safety, Tolerability and Preliminary Efficacy between Standard and Torque Teno Virus-Guided Immunosuppression in Stable Adult Kidney Transplant Recipients with Low Immunological Risk in the First Year after Transplantation – A Trial Protocol.},
  journal = {Transplant International},
  year = {2021},
  volume = {34},
  number = {Suppl 3: Abstracts 34th Annual Meeting of the Austrian Society for Transplantation, Transfusion and Genetics, Spielberg, Austria, 20–22 October 2021},
  pages = {4},
  issn = {0934-0874},
  doi = {10.1111/tri.14036}
}

@ARTICLE{bauer2021icas19143,
  author = {Bauer, P.~ and Brugger, J.~ and K{\"o}nig, F.~ and Posch, M.~},
  title = {An International Comparison of Age and Sex Dependency of COVID-19 Deaths in 2020: A Descriptive Analysis.},
  journal = {Scientific Reports},
  year = {2021},
  volume = {11},
  pages = {19143},
  issn = {2045-2322},
  doi = {10.1038/s41598-021-97711-8}
}

@ARTICLE{puhr2021istas1056s1057,
  author = {Puhr, H.~ and Krotka, P.~ and Koenig, F.~ and Berghoff, A.~ and Preusser, M.~ and Ilhan-Mutlu, A.~},
  title = {Initial Symptoms and Their Association with Survival in Patients with Stage II-III Gastroesophageal Adenocarcinoma.},
  journal = {Annals of Oncology},
  year = {2021},
  volume = {32},
  number = {Suppl 5: Abstracts ESMO Congress 2021, Virtual, 16–21 September 2021},
  pages = {S1056--S1057},
  issn = {0923-7534},
  doi = {10.1016/j.annonc.2021.08.1509}
}

@ARTICLE{ballarini2021osst29392956,
  author = {Ballarini, N.M.~ and Burnett, T.~ and Jaki, T.~ and Jennison, C.~ and K{\"o}nig, F.~ and Posch, M.~},
  title = {Optimizing Subgroup Selection in Two-Stage Adaptive Enrichment and Umbrella Designs.},
  journal = {Statistics in Medicine},
  year = {2021},
  volume = {40},
  number = {12},
  pages = {2939--2956},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.8949},
  keywords = {subgroup analysis;Bayesian optimization;conditional error function;utility function}
}

@ARTICLE{eichhorn2021aimp8395048,
  author = {Eichhorn, T.~ and Linsberger, I.~ and Lauková, L.~ and Tripisciano, C.~ and Fendl, B.~ and Weiss, R.~ and K{\"o}nig, F.~ and Valicek, G.~ and Miestinger, G.~ and H{\"o}rmann, C.~ and Weber, V.~},
  title = {Analysis of Inflammatory Mediator Profiles in Sepsis Patients Reveals That Extracellular Histones Are Strongly Elevated in Nonsurvivors.},
  journal = {Mediators of Inflammation},
  year = {2021},
  volume = {2021},
  pages = {8395048},
  issn = {1466-1861 0962-9351},
  doi = {10.1155/2021/8395048}
}

@ARTICLE{meyer2021sras183,
  author = {Meyer, E.L.~ and Mesenbrink, P.~ and Mielke, T.~ and Parke, T.~ and Evans, D.~ and K{\"o}nig, F.~ and {on behalf of EU-PEARL (EU Patient-cEntric clinicAl tRial pLatforms) Consortium}},
  title = {Systematic Review of Available Software for Multi-Arm Multi-Stage and Platform Clinical Trial Design.},
  journal = {Trials},
  year = {2021},
  volume = {22},
  pages = {183},
  issn = {1745-6215},
  doi = {10.1186/s13063-021-05130-x}
}

@ARTICLE{ristl2021dtet129145,
  author = {Ristl, R.~ and Ballarini, N.M.~ and G{\"o}tte, H.~ and Sch{\"u}ler, A.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {Delayed Treatment Effects, Treatment Switching and Heterogeneous Patient Populations: How to Design and Analyze RCTs in Oncology.},
  journal = {Pharmaceutical Statistics},
  year = {2021},
  volume = {20},
  number = {1},
  pages = {129--145},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.2062}
}

@ARTICLE{posch2021aput4345,
  author = {Posch, M.~ and K{\"o}nig, F.~},
  title = {Are P-Values Useful to Judge the Evidence against the Null Hypotheses in Complex Clinical Trials? A Comment on “The Role of P-values in Judging the Strength of Evidence and Realistic Replication Expectations”.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2021},
  volume = {13},
  number = {1},
  pages = {43--45},
  doi = {10.1080/19466315.2020.1847182},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85097991039\&doi=10.1080%2f19466315.2020.1847182\&partnerID=40\&md5=77e0fbea902ebbc3fbd012314e76a864}
}

@ARTICLE{mielke2021tpcs106112,
  author = {Mielke, J.~ and Jones, B.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {Testing Procedures for Claiming Success on at Least k Out of m Hypotheses with an Application to Biosimilar Development.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2021},
  volume = {13},
  number = {1},
  pages = {106--112},
  issn = {1946-6315},
  doi = {10.1080/19466315.2020.1730233},
  keywords = {Multiple testing;Equivalence testing;Biosimilarity;Closed testing;equivalence;multiple;Multiplicity}
}

@ARTICLE{posch2020aacd685689,
  author = {Posch, M.~ and Bauer, P.~ and Posch, A.~ and K{\"o}nig, F.~},
  title = {Analysis of Austrian COVID-19 Deaths by Age and Sex.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2020},
  volume = {132},
  number = {21-22},
  pages = {685--689},
  doi = {10.1007/s00508-020-01707-9},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85087482708\&doi=10.1007%2fs00508-020-01707-9\&partnerID=40\&md5=311f23665e58e89cfcc7f9543c13615f}
}

@ARTICLE{bretz2020cpw567569,
  author = {Bretz, F.~ and Koenig, F.~},
  title = {Commentary on Parker and Weir.},
  journal = {Clinical Trials},
  year = {2020},
  volume = {17},
  number = {5},
  pages = {567--569},
  doi = {10.1177/1740774520941420},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85087994668\&doi=10.1177%2f1740774520941420\&partnerID=40\&md5=e15ddbbe730ed45209996c9e407b1a47}
}

@ARTICLE{dodd2020ercc472482,
  author = {Dodd, L.E.~ and Follmann, D.~ and Wang, J.~ and Koenig, F.~ and Korn, L.L.~ and Schoergenhofer, C.~ and Proschan, M.~ and Hunsberger, S.~ and Bonnett, T.~ and Makowski, M.~ and Belhadi, D.~ and Wang, Y.~ and Cao, B.~ and Mentre, F.~ and Jaki, T.~},
  title = {Endpoints for Randomized Controlled Clinical Trials for COVID-19 Treatments.},
  journal = {Clinical Trials},
  year = {2020},
  volume = {17},
  number = {5},
  pages = {472--482},
  issn = {1740-7753 1740-7745},
  doi = {10.1177/1740774520939938},
  keywords = {clinical trials;COVID-19;censoring;endpoints;log-rank test;proportional odds model;WHO ordinal scale}
}

@ARTICLE{stallard2020eadc483497,
  author = {Stallard, N.~ and Hampson, L.~ and Benda, N.~ and Brannath, W.~ and Burnett, T.~ and Friede, T.~ and Kimani, P.K.~ and Koenig, F.~ and Krisam, J.~ and Mozgunov, P.~ and Posch, M.~ and Wason, J.~ and Wassmer, G.~ and Whitehead, J.~ and Williamson, S.F.~ and Zohar, S.~ and Jaki, T.~},
  title = {Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2020},
  volume = {12},
  number = {4},
  pages = {483--497},
  doi = {10.1080/19466315.2020.1790415},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85088838170\&doi=10.1080%2f19466315.2020.1790415\&partnerID=40\&md5=94468de2154bdc293f060f004df85157}
}

@ARTICLE{pawelka2020cinj611611,
  author = {Pawelka, E.~ and Karolyi, M.~ and Mader, T.~ and Omid, S.~ and Kelani, H.~ and Baumgartner, S.~ and Ely, S.~ and Jilma, B.~ and Koenig, F.~ and Laferl, H.~ and Turner, M.~ and Traugott, M.~ and Seitz, T.~ and Wenisch, C.~ and Zoufaly, A.~},
  title = {COVID-19 Is Not “Just Another Flu”: A Real-Life Comparison of Severe COVID-19 and Influenza in Hospitalized Patients in Vienna, Austria.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2020},
  volume = {132},
  number = {19-20, Abstracts 44. Jahrestagung der {\"O}sterreichischen Gesellschaft f{\"u}r Pneumologie, Virtuell, 14.–16. Oktober 2020},
  pages = {611},
  issn = {0043-5325},
  url = {https://link.springer.com/article/10.1007/s00508-020-01745-3}
}

@ARTICLE{ballarini2020acrg541560,
  author = {Ballarini, N.M.~ and Chiu, Y.-D.~ and K{\"o}nig, F.~ and Posch, M.~ and Jaki, T.~},
  title = {A Critical Review of Graphics for Subgroup Analyses in Clinical Trials.},
  journal = {Pharmaceutical Statistics},
  year = {2020},
  volume = {19},
  number = {5},
  pages = {541--560},
  issn = {1539-1604},
  doi = {10.1002/pst.2012},
  url = {https://doi.org/10.1002/pst.2012},
  keywords = {contour plot;data visualisation;exploratory data analysis;forest plot;Galbraith plot;STEPP;treatment effect heterogeneity;UpSet plot}
}

@ARTICLE{berghoff2020hcwf150158,
  author = {Berghoff, A.S.~ and Wippel, C.~ and Starzer, A.M.~ and Ballarini, N.~ and Wolpert, F.~ and Bergen, E.~ and Wolf, P.~ and Steindl, A.~ and Widhalm, G.~ and Gatterbauer, B.~ and Marosi, C.~ and Dieckmann, K.~ and Bartsch, R.~ and Scherer, T.~ and Koenig, F.~ and Krebs, M.~ and Weller, M.~ and Preusser, M.~},
  title = {Hypothyroidism Correlates with Favourable Survival Prognosis in Patients with Brain Metastatic Cancer.},
  journal = {European Journal of Cancer},
  year = {2020},
  volume = {135},
  pages = {150--158},
  issn = {1879-0852 0959-8049},
  doi = {10.1016/j.ejca.2020.05.011},
  keywords = {Cancer;Hormones;Metastatic;Thyroid}
}

@ARTICLE{meyer2020empc13301360,
  author = {Meyer, E.L.~ and Mesenbrink, P.~ and Dunger-Baldauf, C.~ and F{\"u}lle, H.-J.~ and Glimm, E.~ and Li, Y.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review.},
  journal = {Clinical Therapeutics},
  year = {2020},
  volume = {42},
  number = {7},
  pages = {1330--1360},
  issn = {1879-114X 0149-2918},
  doi = {10.1016/j.clinthera.2020.05.010},
  keywords = {adaptive design basket trial;master protocol;multi-arm multi-stage design;platform trial}
}

@ARTICLE{dimairo2020adcem115,
  author = {Dimairo, M.~ and Pallmann, P.~ and Wason, J.~ and Todd, S.~ and Jaki, T.~ and Julious, S.A.~ and Mander, A.P.~ and Weir, C.J.~ and Koenig, F.~ and Walton, M.K.~ and Nicholl, J.P.~ and Coates, E.~ and Biggs, K.~ and Hamasaki, T.~ and Proschan, M.A.~ and Scott, J.A.~ and Ando, Y.~ and Hind, D.~ and Altman, D.G.~ and {on Behalf of the ACE Consensus Group}},
  title = {The Adaptive Designs CONSORT Extension (ACE) Statement: A Checklist with Explanation and Elaboration Guideline for Reporting Randomised Trials That Use an Adaptive Design.},
  journal = {BMJ},
  year = {2020},
  volume = {369},
  pages = {m115},
  issn = {1756-1833 0959-8138 0959-8138},
  doi = {10.1136/bmj.m115}
}

@ARTICLE{dimairo2020adce528,
  author = {Dimairo, M.~ and Pallmann, P.~ and Wason, J.~ and Todd, S.~ and Jaki, T.~ and Julious, S.A.~ and Mander, A.P.~ and Weir, C.J.~ and Koenig, F.~ and Walton, M.K.~ and Nicholl, J.P.~ and Coates, E.~ and Biggs, K.~ and Hamasaki, T.~ and Proschan, M.A.~ and Scott, J.A.~ and Ando, Y.~ and Hind, D.~ and Altman, D.G.~ and {on Behalf of the ACE Consensus Group}},
  title = {The Adaptive Designs CONSORT Extension (ACE) Statement: A Checklist with Explanation and Elaboration Guideline for Reporting Randomised Trials That Use an Adaptive Design.},
  journal = {Trials},
  year = {2020},
  volume = {21},
  pages = {528},
  issn = {1745-6215 1745-6215},
  doi = {10.1186/s13063-020-04334-x}
}

@ARTICLE{bayar2020gsad14831498,
  author = {Bayar, M.A.~ and Le Teuff, G.~ and Koenig, F.~ and Le Deley, M.-C.~ and Michiels, S.~},
  title = {Group Sequential Adaptive Designs in Series of Time-to-Event Randomised Trials in Rare Diseases: A Simulation Study.},
  journal = {Statistical Methods in Medical Research},
  year = {2020},
  volume = {29},
  number = {6},
  pages = {1483--1498},
  issn = {1477-0334 0962-2802},
  doi = {10.1177/0962280219862313},
  keywords = {interim analysis;rare diseases;adaptive design;simulation;early stopping;Group sequential;multi-arm multi-stage;series of trials;time-to-event}
}

@ARTICLE{gartlehner2020sasm2028,
  author = {Gartlehner, G.~ and Affengruber, L.~ and Titscher, V.~ and Noel-Storr, A.~ and Dooley, G.~ and Ballarini, N.~ and K{\"o}nig, F.~},
  title = {Single-Reviewer Abstract Screening Missed 13 Percent of Relevant Studies: A Crowd-Based, Randomized Controlled Trial.},
  journal = {Journal of Clinical Epidemiology},
  year = {2020},
  volume = {121},
  pages = {20--28},
  doi = {10.1016/j.jclinepi.2020.01.005},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85079216446\&doi=10.1016%2fj.jclinepi.2020.01.005\&partnerID=40\&md5=5b20b829927d2bc5020878c5b195e95e}
}

@ARTICLE{eichler2020anna773779,
  author = {Eichler, H.-G.~ and Koenig, F.~ and Arlett, P.~ and Enzmann, H.~ and Humphreys, A.~ and Pétavy, F.~ and Schwarzer-Daum, B.~ and Sepodes, B.~ and Vamvakas, S.~ and Rasi, G.~},
  title = {Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2020},
  volume = {107},
  number = {4},
  pages = {773--779},
  issn = {0009-9236},
  doi = {10.1002/cpt.1638}
}

@ARTICLE{thomas2020amcp5368,
  author = {Thomas, M.~ and Bornkamp, B.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {A Multiple Comparison Procedure for Dose-Finding Trials with Subpopulations.},
  journal = {Biometrical Journal},
  year = {2020},
  volume = {62},
  number = {1},
  pages = {53--68},
  issn = {0323-3847},
  doi = {10.1002/bimj.201800111},
  keywords = {multiple testing;subgroup identification;clinical-trials;framework;MCP-Mod;subgroup analyses;targeted therapies}
}

@ARTICLE{janssens2019itmas780s780,
  author = {Janssens, R.~ and Zafiropoulos, N.~ and Koenig, F.~ and Kouroumalis, A.~ and Guizzaro, L.~ and Pignatti, F.~ and Stevens, H.~ and Simoens, S.~ and Huys, I.~ and Posh, M.~},
  title = {Improving the Transparency of Marketing Authorisation Decisions: Towards a Framework for Managing Uncertainties.},
  journal = {Value in Health},
  year = {2019},
  volume = {22},
  number = {Suppl 3: Abstracts ISPOR Europe 2019, Copenhagen, Denmark, 2–6 November 2019},
  pages = {S780},
  issn = {1098-3015},
  doi = {10.1016/j.jval.2019.09.2016},
  url = {https://doi.org/10.1016/j.jval.2019.09.2016}
}

@ARTICLE{dimairo2019iadcabstract p7,
  author = {Dimairo, M.~ and Pallmann, P.~ and Wason, J.~ and Todd, S.~ and Jaki, T.~ and Julious, S.A.~ and Mander, A.P.~ and Weir, C.J.~ and Koenig, F.~ and Walton, M.K.~ and Nicholl, J.P.~ and Coates, E.~ and Biggs, K.~ and Hamasaki, T.~ and Proschan, M.A.~ and Scott, J.A.~ and Ando, Y.~ and Hind, D.~ and Altman, D.G.~},
  title = {Introducing the Adaptive Designs CONSORT Extension (ACE) Statement to Improve Reporting of Randomised Trials That Use an Adaptive Design.},
  journal = {Trials},
  year = {2019},
  volume = {20},
  number = {Suppl 1: Abstracts 5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, 6–9 October 2019},
  pages = {Abstract P-7},
  doi = {10.1186/s13063-019-3688-6}
}

@ARTICLE{boehm2019coif479485,
  author = {Boehm, M.~ and Niewczas, J.~ and Herkner, H.~ and Koenig, F.~ and Kratochwill, K.~ and Rutherford, P.~ and Aufricht, C.~ and Vychytil, A.~},
  title = {Composite Outcome Improves Feasibility of Clinical Trials in Peritoneal Dialysis.},
  journal = {Peritoneal Dialysis International},
  year = {2019},
  volume = {39},
  number = {5},
  pages = {479--485},
  issn = {1718-4304 0896-8608},
  doi = {10.3747/pdi.2018.00214},
  keywords = {Adverse events;clinical development;expert panel;PD fluid;peritonitis;population size;power analysis;technical failure}
}

@ARTICLE{ondra2019oaed20962111,
  author = {Ondra, T.~ and Jobj{\"o}rnsson, S.~ and Beckman, R.A.~ and Burman, C.-F.~ and K{\"o}nig, F.~ and Stallard, N.~ and Posch, M.~},
  title = {Optimized Adaptive Enrichment Designs.},
  journal = {Statistical Methods in Medical Research},
  year = {2019},
  volume = {28},
  number = {7},
  pages = {2096--2111},
  issn = {1477-0334 0962-2802},
  doi = {10.1177/0962280217747312},
  keywords = {Adaptive design;enrichment design;optimal design;precision medicine;subgroup analysis}
}

@ARTICLE{niewczas2019iais665687,
  author = {Niewczas, J.~ and Kunz, C. U.~ and K{\"o}nig, F.~},
  title = {Interim Analysis Incorporating Short- and Long-Term Binary Endpoints.},
  journal = {Biometrical Journal},
  year = {2019},
  volume = {61},
  number = {3},
  pages = {665--687},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201700281},
  keywords = {sample size reassessment;combination test;conditional power;adaptive designs;futility stopping}
}

@ARTICLE{jaki2019rtcj284286,
  author = {Jaki, T.~ and Gordon, A.~ and Forster, P.~ and Bijnens, L.~ and Bornkamp, B.~ and Brannath, W.~ and Fontana, R.~ and Gasparini, M.~ and Hampson, L. V.~ and Jacobs, T.~ and Jones, B.~ and Paoletti, X.~ and Posch, M.~ and Titman, A.~ and Vonk, R.~ and Koenig, F.~},
  title = {Response to Comments on Jaki et al., A Proposal for a New PhD Level Curriculum on Quantitative Methods for Drug Development. Pharm Stat 17(5):593-606, Sep/Oct 2018., DOI: https://doi.org/10.1002/pst.1873.},
  journal = {Pharmaceutical Statistics},
  year = {2019},
  volume = {18},
  number = {3},
  pages = {284--286},
  note = {[Letter to the Editor] [Re Re]},
  issn = {1539-1604},
  doi = {10.1002/pst.1942},
  url = {https://doi.org/10.1002/pst.1942}
}

@ARTICLE{joergens2019nctw329350,
  author = {J{\"o}rgens, S.~ and Wassmer, G.~ and K{\"o}nig, F.~ and Posch, M.~},
  title = {Nested Combination Tests with a Time-to-Event Endpoint Using a Short-Term Endpoint for Design Adaptations.},
  journal = {Pharmaceutical Statistics},
  year = {2019},
  volume = {18},
  number = {3},
  pages = {329--350},
  issn = {1539-1604},
  doi = {10.1002/pst.1926},
  url = {https://doi.org/10.1002/pst.1926},
  keywords = {clinical trials;interim analysis;adaptive design;population enrichment;surrogate endpoint;treatment arm selection}
}

@INCOLLECTION{beckman2019daps141152,
  author = {Beckman, R.A.~ and Burman,  C.-F.~ and Chen, C.~ and Jobj{\"o}rnsson, S.~ and K{\"o}nig, F.~ and Stallard, N.~ and Posch, M.~},
  title = {Decision Analysis from the Perspectives of Single and Multiple Stakeholders.},
  booktitle = {Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials},
  publisher = {Chapman \& Hall/CRC},
  year = {2019},
  editor = {Antonijevic,Z.;Beckman,R.A.},
  series = {Chapman \& Hall/CRC Biostatistics Series},
  pages = {141--152},
  address = {Boca Raton},
  edition = {1st ed.},
  url = {https://www.crcpress.com/Platform-Trial-Designs-in-Drug-Development-Umbrella-Trials-and-Basket-Trials/Antonijevic-Beckman/p/book/9781138052451}
}

@ARTICLE{chiu2018dect43354352,
  author = {Chiu, Y.-D.~ and Koenig, F.~ and Posch, M.~ and Jaki, T.~},
  title = {Design and Estimation in Clinical Trials with Subpopulation Selection.},
  journal = {Statistics in Medicine},
  year = {2018},
  volume = {37},
  number = {29},
  pages = {4335--4352},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.7925},
  keywords = {enrichment design;subgroup analysis;bias;maximum likelihood estimator;prevalence;subpopulation selection}
}

@ARTICLE{vychytil2018arct12271237,
  author = {Vychytil, A.~ and Herzog, R.~ and Probst, P.~ and Ribitsch, W.~ and Lhotta, K.~ and Machold-Fabrizii, V.~ and Wiesholzer, M.~ and Kaufmann, M.~ and Salmhofer, H.~ and Windpessl, M.~ and Rosenkranz, A. R.~ and Oberbauer, R.~ and K{\"o}nig, F.~ and Kratochwill, K.~ and Aufricht, C.~},
  title = {A Randomized Controlled Trial of Alanyl-Glutamine Supplementation in Peritoneal Dialysis Fluid to Assess Impact on Biomarkers of Peritoneal Health.},
  journal = {Kidney International},
  year = {2018},
  volume = {94},
  number = {6},
  pages = {1227--1237},
  issn = {1523-1755 0085-2538},
  doi = {10.1016/j.kint.2018.08.031},
  keywords = {*biocompatibility;*glutamine;*host defense;*peritoneal immune competence;*peritoneal inflammation;*stress response}
}

@ARTICLE{collignon2018adct642,
  author = {Collignon, O.~ and Koenig, F.~ and Koch, A.~ and Hemmings, R. J.~ and Pétavy, F.~ and Saint-Raymond, A.~ and Papaluca-Amati, M.~ and Posch, M.~},
  title = {Adaptive Designs in Clinical Trials: From Scientific Advice to Marketing Authorisation to the European Medicine Agency.},
  journal = {Trials},
  year = {2018},
  volume = {19},
  pages = {642},
  issn = {1745-6215 1745-6215},
  doi = {10.1186/s13063-018-3012-x},
  keywords = {Interim analysis;Clinical trials regulation;Sample size re-assessment;Seamless phase II/III;Stopping for futility}
}

@ARTICLE{dimairo2018dpac210,
  author = {Dimairo, M.~ and Coates, E.~ and Pallmann, P.~ and Todd, S.~ and Julious, S. A.~ and Jaki, T.~ and Wason, J.~ and Mander, A. P.~ and Weir, C. J.~ and Koenig, F.~ and Walton, M. K.~ and Biggs, K.~ and Nicholl, J.~ and Hamasaki, T.~ and Proschan, M. A.~ and Scott, J. A.~ and Ando, Y.~ and Hind, D.~ and Altman, D. G.~},
  title = {Development Process of a Consensus-Driven CONSORT Extension for Randomised Trials Using an Adaptive Design.},
  journal = {BMC Medicine},
  year = {2018},
  volume = {16},
  pages = {210},
  issn = {1741-7015 1741-7015},
  doi = {10.1186/s12916-018-1196-2},
  keywords = {Humans;Consensus;Europe;Decision Support Techniques;Asia;Research Design/*standards;*Adaptive design;*CONSORT extension;*Flexible design;*Randomised controlled trial;*Reporting guidance;*Reporting guideline;Checklist;Randomized Controlled Trials as Topic/*standards}
}

@ARTICLE{thomas2018amcp181109824,
  author = {Thomas, M.~ and Bornkamp, B.~ and Posch, M.~ and K{\"o}nig, F.~},
  title = {A Multiple Comparison Procedure for Dose-Finding Trials with Subpopulations.},
  journal = {arXiv},
  year = {2018},
  pages = {1811.09824},
  url = {https://arxiv.org/abs/1811.09824},
  keywords = {Statistics - Methodology}
}

@ARTICLE{sugitani2018faas33873402,
  author = {Sugitani, T.~ and Posch, M.~ and Bretz, F.~ and Koenig, F.~},
  title = {Flexible Alpha Allocation Strategies for Confirmatory Adaptive Enrichment Clinical Trials with a Prespecified Subgroup.},
  journal = {Statistics in Medicine},
  year = {2018},
  volume = {37},
  number = {24},
  pages = {3387--3402},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.7851},
  keywords = {subgroup analysis;adaptive enrichment design;closed testing procedure;combination test;feedback procedure;partial conditional error rate}
}

@ARTICLE{ballarini2018sicte0205971,
  author = {Ballarini, N.M.~ and Rosenkranz, G.K.~ and Jaki, T.~ and K{\"o}nig, F.~ and Posch, M.~},
  title = {Subgroup Identification in Clinical Trials via the Predicted Individual Treatment Effect.},
  journal = {PLoS One},
  year = {2018},
  volume = {13},
  number = {10},
  pages = {e0205971},
  issn = {1932-6203 1932-6203},
  doi = {10.1371/journal.pone.0205971},
  keywords = {Humans;Male;Time Factors;Sensitivity and Specificity;Treatment Outcome;Confidence Intervals;Computer Simulation;*Clinical Trials as Topic;Databases as Topic;*Precision Medicine;Alzheimer Disease/therapy;Prostatic Neoplasms/therapy}
}

@ARTICLE{jaki2018apan593606,
  author = {Jaki, T.~ and Gordon, A.~ and Forster, P.~ and Bijnens, L.~ and Bornkamp, B.~ and Brannath, W.~ and Fontana, R.~ and Gasparini, M.~ and Hampson, L. V.~ and Jacobs, T.~ and Jones, B.~ and Paoletti, X.~ and Posch, M.~ and Titman, A.~ and Vonk, R.~ and Koenig, F.~},
  title = {A Proposal for a New PhD Level Curriculum on Quantitative Methods for Drug Development.},
  journal = {Pharmaceutical Statistics},
  year = {2018},
  volume = {17},
  number = {5},
  pages = {593--606},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.1873},
  keywords = {Humans;Europe;*development of early-stage researchers;*drug development;*PhD curriculum;*regulatory statistics;*university-industry partnership;Cooperative Behavior;Curriculum;Drug Development/*education/statistics \& numerical data;Drug Industry/organization \& administration;Education;Graduate/*methods;Private Sector;Public Sector;Research/organization \& administration;Statistics as Topic/*education}
}

@ARTICLE{mielke2018ucet14151431,
  author = {Mielke, J.~ and Jilma, B.~ and Jones, B.~ and Koenig, F.~},
  title = {An Update on the Clinical Evidence That Supports Biosimilar Approvals in Europe.},
  journal = {British Journal of Clinical Pharmacology},
  year = {2018},
  volume = {84},
  number = {7},
  pages = {1415--1431},
  issn = {1365-2125 0306-5251},
  doi = {10.1111/bcp.13586},
  keywords = {clinical trials;drug development;statistics and study design;systematic review}
}

@ARTICLE{posch2018eabs18301846,
  author = {Posch, M.~ and Klinglmueller, F.~ and K{\"o}nig, F.~ and Miller, F.~},
  title = {Estimation after Blinded Sample Size Reassessment.},
  journal = {Statistical Methods in Medical Research},
  year = {2018},
  volume = {27},
  number = {6},
  pages = {1830--1846},
  issn = {1477-0334 0962-2802},
  doi = {10.1177/0962280216670424},
  keywords = {Adaptive design;interim analysis;internal pilot study;point estimate;sample size reassessment}
}

@ARTICLE{hilgers2018lli377,
  author = {Hilgers, R.-D.~ and Bogdan, M.~ and Burman, C.-F.~ and Dette, H.~ and Karlsson, M.~ and K{\"o}nig, F.~ and Male, C.~ and Mentré, F.~ and Molenberghs, G.~ and Senn, S.~},
  title = {Lessons Learned from IDeAl – 33 Recommendations from the IDeAl-Net about Design and Analysis of Small Population Clinical Trials.},
  journal = {Orphanet Journal of Rare Diseases},
  year = {2018},
  volume = {13},
  pages = {77},
  issn = {1750-1172 1750-1172},
  doi = {10.1186/s13023-018-0820-8},
  keywords = {*Rare disease;*Small population clinical trials;*Statistical analysis;*Statistical design;*Statistical methodology}
}

@ARTICLE{vychytil2018apdfi621i621,
  author = {Vychytil, A.~ and Herzog, R.~ and Probst, P.~ and Ribitsch, W.~ and Lhotta, K.~ and Machold-Fabrizii, V.~ and Wiesholzer, M.~ and Kaufmann, M.~ and Salmhofer, H.~ and Windpessl, M.~ and K{\"o}nig, F.~ and Rosenkranz, A.~ and Oberbauer, R.~ and Kratochwill, K.~ and Aufricht, C.~},
  title = {Alanyl-Glutamine in Peritoneal Dialysis Fluids Improves Peritoneal Health and Systemic Inflammation: A Double-Blinded Randomized Crossover Trial.},
  journal = {Nephrology Dialysis Transplantation},
  year = {2018},
  volume = {33},
  number = {Suppl 1: Abstracts 55th European Renal Association (ERA)–European Dialysis and Transplantation Association (EDTA) Congress, Copenhagen, Denmark, 24–27 May 2018},
  pages = {i621},
  issn = {0931-0509},
  doi = {10.1093/ndt/gfy104.SuO013}
}

@ARTICLE{mielke2018ssmh3949,
  author = {Mielke, J.~ and Jones, B.~ and Jilma, B.~ and K{\"o}nig, F.~},
  title = {Sample Size for Multiple Hypothesis Testing in Biosimilar Development.},
  journal = {Statistics in Biopharmaceutical Research},
  year = {2018},
  volume = {10},
  number = {1},
  pages = {39--49},
  doi = {10.1080/19466315.2017.1371071},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85044641475\&doi=10.1080%2f19466315.2017.1371071\&partnerID=40\&md5=5374656012caffa8ea409fe6cb7e5b79}
}

@ARTICLE{hofer2018maom424433,
  author = {Hofer, M.P.~ and Hedman, H.~ and Mavris, M.~ and Koenig, F.~ and Vetter, T.~ and Posch, M.~ and Vamvakas, S.~ and Regnstrom, J.~ and Aarum, S.~},
  title = {Marketing Authorisation of Orphan Medicines in Europe from 2000 to 2013.},
  journal = {Drug Discovery Today},
  year = {2018},
  volume = {23},
  number = {2},
  pages = {424--433},
  issn = {1878-5832 1359-6446},
  doi = {10.1016/j.drudis.2017.10.012},
  keywords = {Humans;Europe;Drug Approval/statistics \& numerical data;Marketing/*statistics \& numerical data;Orphan Drug Production/*statistics \& numerical data}
}

@ARTICLE{eichhorn2017cspc260266,
  author = {Eichhorn, T.~ and Hartmann, J.~ and Harm, S.~ and Linsberger, I.~ and K{\"o}nig, F.~ and Valicek, G.~ and Miestinger, G.~ and H{\"o}rmann, C.~ and Weber, V.~},
  title = {Clearance of Selected Plasma Cytokines with Continuous Veno-Venous Hemodialysis Using Ultraflux EMiC2 versus Ultraflux AV1000S.},
  journal = {Blood Purification},
  year = {2017},
  volume = {44},
  number = {4},
  pages = {260--266},
  issn = {1421-9735 0253-5068},
  doi = {10.1159/000478965},
  keywords = {Female;Humans;Male;*Renal Dialysis;C-Reactive Protein/metabolism;*Continuous veno-venous hemodialysis;*Cytokine clearance;*High cutoff filter;*Interleukin-6;Cytokines/*blood;Sepsis/*blood/*therapy}
}

@CONFERENCE{dimairo2017jtda5253,
  author = {Dimairo, M.~ and  Todd, S.~ and Julious, S.~ and Jaki, T.~ and Wason, J.~ and Hind, D.~ and Mander, A.~ and Weir, C.~ and Koenig, F.~ and Altman, D.~ and Nicholl, J.~ and Hamasaki, T.~ and Proschan, M.~ and Scott, J.~ and Walton, M.~ and Ando, Y.~ and Biggs, K.~ and Pallmann, P.~ and Coates, E.~},
  title = {Journeying through the Development of a Consensus-Driven Adaptive Designs Reporting Guidance.},
  booktitle = {Conference Booklet: Ethics of Alternative Clinical Trial Designs and Methods in LMIC Research, Bangkok, Thailand, 28 and 29 November 2017},
  year = {2017},
  editor = {Global Forum on Bioethics in Research},
  pages = {52--53},
  address = {London},
  publisher = {GFBR},
  url = {http://gfbr.global/wp-content/uploads/2017/12/GFBR-Booklet-2017-without-participant-details.pdf}
}

@INCOLLECTION{bretz2017mtsc279290,
  author = {Bretz, F.~ and Bornkamp, B.~ and K{\"o}nig, F.~},
  title = {Multiple Test Strategies for Comparing Several Doses with a Control in Confirmatory Trials.},
  booktitle = {Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials},
  publisher = {Chapman \& Hall/CRC},
  year = {2017},
  editor = {O’Quigley,J.;Iasonos,A.;Bornkamp,B.},
  series = {Handbooks of Modern Statistical Methods},
  pages = {279--290},
  address = {Boca Raton},
  url = {https://www.crcpress.com/Handbook-of-Methods-for-Designing-Monitoring-and-Analyzing-Dose-Finding/OQuigley-Iasonos-Bornkamp/p/book/9780367330682}
}

@ARTICLE{hlavin2017mcase0180131,
  author = {Hlavin, G.~ and Hampson, L. V.~ and Koenig, F.~},
  title = {Many-to-One Comparisons after Safety Selection in Multi-Arm Clinical Trials.},
  journal = {PLoS One},
  year = {2017},
  volume = {12},
  number = {6},
  pages = {e0180131},
  issn = {1932-6203 1932-6203},
  doi = {10.1371/journal.pone.0180131},
  keywords = {Humans;Models;Statistical;Biostatistics;Clinical Trials;Phase II as Topic/*methods/statistics \& numerical data;Clinical Trials;Phase III as Topic/*methods/statistics \& numerical data;Computer Simulation;Controlled Clinical Trials as Topic/methods/statistics \& numerical data;Randomized Controlled Trials as Topic/methods/statistics \& numerical data;Safety;Sample Size}
}

@ARTICLE{chiu2017gdtsabstract p475,
  author = {Chiu, Y.~ and Koenig, F.~ and Posch, M.~ and Jaki, T.~},
  title = {Graphical Display Techniques for Subgroup Analysis.},
  journal = {Trials},
  year = {2017},
  volume = {18},
  number = {Suppl 1: Abstracts 4th International Clinical Trials Methodology Conference (ICTMC) and 38th Annual Meeting of the Society for Clinical Trials, Liverpool, UK, 7–10 May 2017},
  pages = {Abstract P475},
  issn = {1745-6215},
  doi = {10.1186/s13063-017-1902-y}
}

@ARTICLE{hilgers2017idas1416,
  author = {Hilgers, R.-D.~ and Bogdan, M.~ and Burman, C.-F.~ and Dette, H.~ and Karlsson, M.~ and K{\"o}nig, F.~ and Male, C.~ and Mentré, F.~ and Molenberghs, G.~ and Senn, S.~},
  title = {Integrated Design and Analysis of Small Population Group Trials – IDEAL – FP7.},
  journal = {Impact},
  year = {2017},
  volume = {2017},
  number = {4},
  pages = {14--16},
  issn = {2398-7073},
  doi = {doi:10.21820/23987073.2017.4.14},
  url = {https://www.ingentaconnect.com/content/sil/impact/2017/00002017/00000004/art00005},
  keywords = {BIOMARKER SURROGATE ENDPOINTS;CLINICAL TRIALS;DECISION ANALYSIS;EXTRAPOLATING DOSE-RESPONSE INFORMATION;GENETIC FACTORS INFLUENCING THE RESPONSE;IADAPTIVE DESIGNS;OPTIMAL DESIGNS IN MIXED MODELS;PHARMACOGENETIC DESIGNS;RANDOMIZATION;RARE DISEASE;SAMPLE POPULATION GROUPS;SIMULATION OF CLINICAL TRIALS;SPG;STATISTICAL ANALYSIS METHODOLOGY;STATITICAL DESIGN METHODOLOGY}
}

@ARTICLE{eskandary2017dcda631641,
  author = {Eskandary, F.~ and Bond, G.~ and Kozakowski, N.~ and Regele, H.~ and Marinova, L.~ and Wahrmann, M.~ and Kikić, Ž.~ and Haslacher, H.~ and Rasoul-Rockenschaub, S.~ and Kaltenecker, C. C.~ and K{\"o}nig, F.~ and Hidalgo, L. G.~ and Oberbauer, R.~ and Halloran, P. F.~ and B{\"o}hmig, G. A.~},
  title = {Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection—Results of a Cross-Sectional Screening Study.},
  journal = {Transplantation},
  year = {2017},
  volume = {101},
  number = {3},
  pages = {631--641},
  issn = {1534-6080 0041-1337},
  doi = {10.1097/TP.0000000000001195},
  keywords = {Adult;Female;Humans;Male;Risk Factors;Middle Aged;ROC Curve;Area Under Curve;Predictive Value of Tests;Prospective Studies;Cross-Sectional Studies;Multivariate Analysis;Treatment Outcome;Biomarkers/blood;Prevalence;*Flow Cytometry;Asymptomatic Diseases;Biopsy;Chi-Square Distribution;Complement Fixation Tests;Complement System Proteins/analysis;Graft Rejection/blood/*diagnosis/epidemiology/immunology;Histocompatibility;HLA Antigens/*immunology;Immunoglobulin G/*blood;Isoantibodies/*blood;Kidney Transplantation/*adverse effects;Kidney/*immunology/pathology;Serologic Tests}
}

@ARTICLE{ebenbichler2016dirt871879,
  author = {Ebenbichler, G.R.~ and Leitgeb, J.~ and Amtmann, G.~ and K{\"o}nig, F.~ and Schernthaner, M.~ and Resch, K.-L.~ and Kainberger, F.~},
  title = {Degeneration and Instability and the Relation to Patients’ Function Late after Lumbar Disc Surgery. Data from a 12-Year Follow-Up.},
  journal = {American Journal of Physical Medicine \& Rehabilitation},
  year = {2016},
  volume = {95},
  number = {12},
  pages = {871--879},
  issn = {1537-7385 0894-9115},
  doi = {10.1097/PHM.0000000000000522},
  keywords = {Female;Humans;Male;Retrospective Studies;Time Factors;Aged;Middle Aged;Follow-Up Studies;Pain Measurement;Range of Motion;Articular;Diskectomy;Laminectomy;*Lumbar Vertebrae;Intervertebral Disc Degeneration/diagnosis/*epidemiology/*surgery;Joint Instability/diagnosis/*epidemiology;Low Back Pain/diagnosis/*epidemiology/surgery;Postoperative Complications/diagnosis/*epidemiology}
}

@ARTICLE{mielke2016ctab14441457,
  author = {Mielke, J.~ and Jilma, B.~ and Koenig, F.~ and Jones, B.~},
  title = {Clinical Trials for Authorized Biosimilars in the European Union: A Systematic Review.},
  journal = {British Journal of Clinical Pharmacology},
  year = {2016},
  volume = {82},
  number = {6},
  pages = {1444--1457},
  issn = {1365-2125 0306-5251},
  doi = {10.1111/bcp.13076},
  keywords = {Humans;Endpoint Determination;Treatment Outcome;Research Design;Sample Size;European Union;Drug Approval;*Clinical Trials as Topic;*biosimilar drug development programmes;*biosimilarity;*biosimilars;*EMA;*EPAR;*trial design;Biosimilar Pharmaceuticals/pharmacokinetics/pharmacology/*therapeutic use}
}

@ARTICLE{eichler2016tauw699712,
  author = {Eichler, H.-G.~ and Bloechl-Daum, B.~ and Bauer, P.~ and Bretz, F.~ and Brown, J.~ and Hampson, L. V.~ and Honig, P.~ and Krams, M.~ and Leufkens, H.~ and Lim, R.~ and Lumpkin, M. M.~ and Murphy, M. J.~ and Pignatti, F.~ and Posch, M.~ and Schneeweiss, S.~ and Trusheim, M.~ and Koenig, F.~},
  title = {“Threshold-Crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?},
  journal = {Clinical Pharmacology and Therapeutics},
  year = {2016},
  volume = {100},
  number = {6},
  pages = {699--712},
  issn = {1532-6535 0009-9236},
  doi = {10.1002/cpt.515},
  keywords = {Humans;Models;Theoretical;Treatment Outcome;*Research Design;Randomized Controlled Trials as Topic/*methods;Pharmaceutical Preparations/*administration \& dosage}
}

@ARTICLE{hilgers2016dact5360,
  author = {Hilgers, R.-D.~ and K{\"o}nig, F.~ and Molenberghs, G.~ and Senn, S.~},
  title = {Design and Analysis of Clinical Trials for Small Rare Disease Populations.},
  journal = {Journal of Rare Diseases Research \& Treatment},
  year = {2016},
  volume = {1},
  number = {3},
  pages = {53--60},
  doi = {10.29245/2572-9411/2016/3.1054}
}

@ARTICLE{bauer2016apip384386,
  author = {Bauer, P.~ and K{\"o}nig, F.~},
  title = {Adaptive Paediatric Investigation Plans, a Small Step to Improve Regulatory Decision Making in Drug Development for Children?},
  journal = {Pharmaceutical Statistics},
  year = {2016},
  volume = {15},
  number = {5},
  pages = {384--386},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.1762},
  keywords = {Humans;Child;Europe;*drug development;*extrapolation;*adaptive;*clinical trials;*Decision Making;*European regulation;*paediatric medicine;Drug Discovery/*legislation \& jurisprudence/trends;Pediatrics/*legislation \& jurisprudence/trends}
}

@ARTICLE{ondra2016otdte0163726,
  author = {Ondra, T.~ and Jobj{\"o}rnsson, S.~ and Beckman, R.A.~ and Burman, C.-F.~ and K{\"o}nig, F.~ and Stallard, N.~ and Posch, M.~},
  title = {Optimizing Trial Designs for Targeted Therapies.},
  journal = {PLoS One},
  year = {2016},
  volume = {11},
  number = {9},
  pages = {e0163726},
  issn = {1932-6203 1932-6203},
  doi = {10.1371/journal.pone.0163726}
}

@ARTICLE{hlavin2016eee21172132,
  author = {Hlavin, G.~ and Koenig, F.~ and Male, C.~ and Posch, M.~ and Bauer, P.~},
  title = {Evidence, Eminence and Extrapolation.},
  journal = {Statistics in Medicine},
  year = {2016},
  volume = {35},
  number = {13},
  pages = {2117--2132},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.6865},
  keywords = {Humans;Treatment Outcome;*Statistics as Topic;Child;Data Interpretation;Statistical;Sample Size;Decision Trees;Clinical Trials as Topic/*methods;*adjustment of the significance level;*extrapolation;*prior belief;*reduction of sample size;*small population}
}

@ARTICLE{hilgers2016dnds78,
  author = {Hilgers, R.-D.~ and Roes, K.~ and Stallard, N.~ and {and for the IDeAl, Asterix, InSPiRe Project Groups}},
  title = {Directions for New Developments on Statistical Design and Analysis of Small Population Group Trials.},
  journal = {Orphanet Journal of Rare Diseases},
  year = {2016},
  volume = {11},
  pages = {78},
  issn = {1750-1172 1750-1172},
  doi = {10.1186/s13023-016-0464-5},
  keywords = {Humans;Clinical Trials as Topic;*Data Interpretation;Statistical;Rare Diseases;Population Groups;*Statistical methods;*Rare disease;*EMA/CHMP Guideline on clinical trials in small populations;*Small population clinical trials;*Statistical analysis;*Statistical design}
}

@ARTICLE{magirr2016ssrhe0146465,
  author = {Magirr, D.~ and Jaki, T.~ and Koenig, F.~ and Posch, M.~},
  title = {Sample Size Reassessment and Hypothesis Testing in Adaptive Survival Trials.},
  journal = {PLoS One},
  year = {2016},
  volume = {11},
  number = {2},
  pages = {e0146465},
  issn = {1932-6203 1932-6203},
  doi = {10.1371/journal.pone.0146465},
  keywords = {Humans;Follow-Up Studies;Sample Size;Survival Analysis;Clinical Trials as Topic/*methods}
}

@ARTICLE{bauer2016tyca325347,
  author = {Bauer, P.~ and Bretz, F.~ and Dragalin, V.~ and K{\"o}nig, F.~ and Wassmer, G.~},
  title = {Twenty-Five Years of Confirmatory Adaptive Designs: Opportunities and Pitfalls.},
  journal = {Statistics in Medicine},
  year = {2016},
  volume = {35},
  number = {3},
  pages = {325--347},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.6472},
  keywords = {Humans;clinical trials;Data Interpretation;Statistical;*Research Design;adaptive design;group sequential designs;Software Design;*Sample Size;Clinical Trials as Topic/methods/*statistics \& numerical data;*Meta-Analysis as Topic;Biometry/*methods;Endpoint Determination/methods/statistics \& numerical data}
}

@ARTICLE{bauer2016artc364367,
  author = {Bauer, P.~ and Bretz, F.~ and Dragalin, V.~ and K{\"o}nig, F.~ and Wassmer, G.~},
  title = {Authors’ Response to Comments.},
  journal = {Statistics in Medicine},
  year = {2016},
  volume = {35},
  number = {3},
  pages = {364--367},
  note = {[Correspondence] [Re Re Re Re]},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.6823}
}

@ARTICLE{koenig2015atbtabstract p218,
  author = {Koenig, F.~ and Wolfsegger, M.~ and Jaki, T.~ and Sch{\"u}tz, H.~ and Wassmer, G.~},
  title = {Adaptive Two-Stage Bioequivalence Trials with Early Stopping and Sample Size Re-Estimation.},
  journal = {Trials},
  year = {2015},
  volume = {16},
  number = {Suppl 2: Abstracts 3rd International Clinical Trials Methodology Conference, Glasgow, UK, 16–17 November 2015},
  pages = {Abstract P218},
  issn = {1745-6215},
  url = {https://resource-cms.springernature.com/springer-cms/rest/v1/content/7835282/data/v1#page=79}
}

@ARTICLE{ebenbichler2015rdiis206s206,
  author = {Ebenbichler, G.~ and Leitgeb, J.~ and Amtmann, G.~ and Friedrich, K.~ and K{\"o}nig, F.~ and Resch, K. L.~ and Schernthaner, M.~ and Kainberger, F.~},
  title = {The Risk of Degeneration and Instability and Its Relation to Patient’s Function Late after Lumbar Disk Surgery.},
  journal = {PM\&R},
  year = {2015},
  volume = {7},
  number = {9, Suppl: 2015AAPM\&R Annual Assembly Abstracts, Boston, MA, USA, 1–4 October 2015},
  pages = {S206},
  issn = {1934-1482},
  doi = {10.1016/j.pmrj.2015.06.387},
  url = {https://doi.org/10.1016/j.pmrj.2015.06.387}
}

@ARTICLE{schwarz2015lobt820827,
  author = {Schwarz, C.~ and Mayerhoffer, S.~ and Berlakovich, G. A.~ and Steininger, R.~ and Soliman, T.~ and Watschinger, B.~ and B{\"o}hmig, G. A.~ and Eskandary, F.~ and K{\"o}nig, F.~ and M{\"u}hlbacher, F.~ and Wekerle, T.~},
  title = {Long-Term Outcome of Belatacept Therapy in De Novo Kidney Transplant Recipients – A Case-Match Analysis.},
  journal = {Transplant International},
  year = {2015},
  volume = {28},
  number = {7},
  pages = {820--827},
  issn = {1432-2277 0934-0874},
  doi = {10.1111/tri.12544},
  keywords = {Adult;Female;Humans;Male;Retrospective Studies;Aged;Middle Aged;Treatment Outcome;Kaplan-Meier Estimate;kidney transplantation;belatacept;immunosuppression;Kidney Function Tests;long-term outcome;Matched-Pair Analysis;*Kidney Transplantation/mortality;Abatacept/*therapeutic use;Cyclosporine/therapeutic use;Graft Rejection/diagnosis/immunology/mortality/*prevention \& control;Graft Survival/immunology;Immunosuppressive Agents/*therapeutic use;Kidney Failure;Chronic/mortality/*surgery}
}

@ARTICLE{koenig2015sctd826,
  author = {Koenig, F.~ and Slattery, J.~ and Groves, T.~ and Lang, T.~ and Benjamini, Y.~ and Day, S.~ and Bauer, P.~ and Posch, M.~},
  title = {Sharing Clinical Trial Data on Patient Level: Opportunities and Challenges.},
  journal = {Biometrical Journal},
  year = {2015},
  volume = {57},
  number = {1},
  pages = {8--26},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201300283},
  keywords = {Humans;Biostatistics;EMA draft policy/0070;Open access to clinical trial data;Periodicals as Topic;Policy;Raw data;Secondary research;Transparency;Validation;*Clinical Trials as Topic;Information Dissemination/*methods}
}

@ARTICLE{graf2015adsa7689,
  author = {Graf, A.C.~ and Posch, M.~ and Koenig, F.~},
  title = {Adaptive Designs for Subpopulation Analysis Optimizing Utility Functions.},
  journal = {Biometrical Journal},
  year = {2015},
  volume = {57},
  number = {1},
  pages = {76--89},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201300257},
  keywords = {Humans;Adaptive design;Treatment Outcome;Clinical Trials as Topic;Biomarkers/metabolism;Risk Assessment;Enrichment design;Hypothesis selection;Sample size reallocation;Utility function;Biometry/*methods}
}

@ARTICLE{klinglmueller2014agmt345356,
  author = {Klinglmueller, F.~ and Posch, M.~ and Koenig, F.~},
  title = {Adaptive Graph-Based Multiple Testing Procedures.},
  journal = {Pharmaceutical Statistics},
  year = {2014},
  volume = {13},
  number = {6},
  pages = {345--356},
  issn = {1539-1612 1539-1604},
  doi = {10.1002/pst.1640},
  keywords = {Humans;multiple endpoints;partial conditional error rate;adaptive design;graphical approach;multiple comparisons;treatment selection;Clinical Trials as Topic/methods/*statistics \& numerical data;Research Design/*statistics \& numerical data}
}

@ARTICLE{elsaeßer2014actd383,
  author = {Els{\"a}ßer, A.~ and Regnstrom, J.~ and Vetter, T.~ and Koenig, F.~ and Hemmings, R. J.~ and Greco, M.~ and Papaluca-Amati, M.~ and Posch, M.~},
  title = {Adaptive Clinical Trial Designs for European Marketing Authorization: A Survey of Scientific Advice Letters from the European Medicines Agency.},
  journal = {Trials},
  year = {2014},
  volume = {15},
  pages = {383},
  issn = {1745-6215 1745-6215},
  doi = {10.1186/1745-6215-15-383},
  keywords = {Humans;Europe;Sample Size;Practice Guidelines as Topic;*Advisory Committees/standards;*Correspondence as Topic;*Marketing of Health Services;*Research Design/standards;Clinical Trials;Phase II as Topic/*methods/standards;Clinical Trials;Phase III as Topic/*methods/standards}
}

@ARTICLE{beck2014oeth824838,
  author = {Beck, F.~ and Dumitrescu, N.~ and K{\"o}nig, F.~ and Graf, A.~ and Bauer, P.~ and Sperr, W.~ and Moritz, A.~ and Schedle, A.~},
  title = {One-Year Evaluation of Two Hybrid Composites Placed in a Randomized-Controlled Clinical Trial.},
  journal = {Dental Materials},
  year = {2014},
  volume = {30},
  number = {8},
  pages = {824--838},
  issn = {1879-0097 0109-5641},
  doi = {10.1016/j.dental.2014.05.006},
  keywords = {Adult;Female;Humans;Male;Young Adult;Prospective Studies;Class I restorations;Class II restorations;Longevity;Randomized controlled clinical trial;Resin composite;Total etch;Dental Restoration;Permanent;*Bisphenol A-Glycidyl Methacrylate;*Composite Resins}
}

@ARTICLE{eskandary2014aacd445445,
  author = {Eskandary, F.~ and Wahrmann, M.~ and Biesenbach, P.~ and Sandurkov, C.~ and Koenig, F.~ and Schwaiger, E.~ and Perkmann, T.~ and Kuenig, S.~ and Derfler, K.~ and Zlabinger, G.~ and Boehmig, G.~},
  title = { ABO Antibody and Complement Depletion by Immunoadsorption Combined with Membrane Filtration – A Randomized Controlled Crossover Trial.},
  journal = {Transplantation},
  year = {2014},
  volume = {98},
  number = {Suppl 1: Abstracts 2014 World Transplantation Congress, San Francisco, CA, USA, 26–31 July 2014},
  pages = {445},
  doi = {10.1097/00007890-201407151-01477},
  url = {https://journals.lww.com/transplantjournal/Fulltext/2014/07151/ABO_Antibody_and_Complement_Depletion_By.1477.aspx}
}

@ARTICLE{graf2014mt1e614630,
  author = {Graf, A. C.~ and Bauer, P.~ and Glimm, E.~ and Koenig, F.~},
  title = {Maximum Type 1 Error Rate Inflation in Multiarmed Clinical Trials with Adaptive Interim Sample Size Modifications.},
  journal = {Biometrical Journal},
  year = {2014},
  volume = {56},
  number = {4},
  pages = {614--630},
  issn = {1521-4036 0323-3847},
  doi = {10.1002/bimj.201300153},
  keywords = {Humans;*Research Design;Decision Making;Sample Size;Conditional error function;Interim analysis;Maximum type 1 error;Sample size reassessment;Treatment selection;Clinical Trials as Topic/*methods;Biometry/*methods}
}

@MISC{magirr2014ast14051569,
  author = {Magirr, D.~ and Jaki, T.~ and Koenig, F.~ and Posch, M.~},
  title = {Adaptive Survival Trials.},
  year = {2014},
  doi = {https://arxiv.org/abs/1405.1569},
  url = {https://ui.adsabs.harvard.edu/abs/2014arXiv1405.1569M},
  keywords = {62N03;Statistics - Applications}
}

@ARTICLE{bauer2014rmad317318,
  author = {Bauer, P.~ and K{\"o}nig, F.~},
  title = {The Risks of Methodology Aversion in Drug Regulation.},
  journal = {Nature Reviews Drug Discovery},
  year = {2014},
  volume = {13},
  number = {5},
  pages = {317--318},
  note = {[Correspondence]},
  doi = {10.1038/nrd4319},
  url = {https://doi.org/10.1038/nrd4319}
}

@ARTICLE{eskandary2014aacd706714,
  author = {Eskandary, F.~ and Wahrmann, M.~ and Biesenbach, P.~ and Sandurkov, C.~ and K{\"o}nig, F.~ and Schwaiger, E.~ and Perkmann, T.~ and K{\"u}nig, S.~ and Derfler, K.~ and Zlabinger, G. J.~ and B{\"o}hmig, G. A.~},
  title = {ABO Antibody and Complement Depletion by Immunoadsorption Combined with Membrane Filtration—A Randomized, Controlled, Cross-Over Trial.},
  journal = {Nephrology, Dialysis, Transplantation},
  year = {2014},
  volume = {29},
  number = {3},
  pages = {706--714},
  issn = {1460-2385 0931-0509},
  doi = {10.1093/ndt/gft502},
  keywords = {Adult;Female;Humans;Male;Middle Aged;Cross-Over Studies;transplantation;*Kidney Transplantation;Graft Rejection/*prevention \& control;randomized trial;ABO incompatibility;Adsorption;complement;immunoadsorption;immunoglobulins;Membranes;Artificial;Renal Dialysis;ABO Blood-Group System/immunology;Autoantibodies/blood/isolation \& purification;Blood Group Incompatibility/prevention \& control;Complement C1q/isolation \& purification/metabolism;Kidney Diseases/surgery}
}

@ARTICLE{koenig2013jeid16191620,
  author = {Koenig, F.~ and Bretz, F.~},
  title = {Joint EMA, ISBS, and DR-IBS International Symposium on Biopharmaceutical Statistics: Bridging Drug Development from Research to Marketing.},
  journal = {Statistics in Medicine},
  year = {2013},
  volume = {32},
  number = {107: Special Issue: Second International Symposium on Biopharmaceutical Statistics, Berlin, Germany, 1–3 March 2011},
  pages = {1619--1620},
  note = {[Editorial]},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.5739},
  keywords = {Humans;Marketing;*Biostatistics;Biopharmaceutics/*statistics \& numerical data;Drug Discovery/statistics \& numerical data}
}

@ARTICLE{blueml2013lpws407411,
  author = {Bl{\"u}ml, V.~ and Regier, M. D.~ and Hlavin, G.~ and Rockett, I. R. H.~ and K{\"o}nig, F.~ and Vyssoki, B.~ and Bschor, T.~ and Kapusta, N. D.~},
  title = {Lithium in the Public Water Supply and Suicide Mortality in Texas.},
  journal = {Journal of Psychiatric Research},
  year = {2013},
  volume = {47},
  number = {3},
  pages = {407--411},
  issn = {1879-1379 0022-3956},
  doi = {10.1016/j.jpsychires.2012.12.002},
  keywords = {Female;Humans;Male;Prevalence;Regression Analysis;Water Supply/*analysis;*Suicide;Lithium/*analysis;Self-Injurious Behavior/*epidemiology/etiology/*mortality;Texas/epidemiology}
}

@ARTICLE{wahrmann2013msad3240,
  author = {Wahrmann, M.~ and Hlavin, G.~ and Fischer, G.~ and Marinova, L.~ and Schwaiger, E.~ and H{\"o}rl, W. H.~ and Zlabinger, G. J.~ and K{\"o}rm{\"o}czi, G. F.~ and K{\"o}nig, F.~ and B{\"o}hmig, G. A.~},
  title = {Modified Solid-Phase Alloantibody Detection for Improved Crossmatch Prediction.},
  journal = {Human Immunology},
  year = {2013},
  volume = {74},
  number = {1},
  pages = {32--40},
  issn = {1879-1166 0198-8859},
  doi = {10.1016/j.humimm.2012.10.012},
  keywords = {Humans;ROC Curve;Tissue Donors;Flow Cytometry;Organ Transplantation;*Cytotoxicity Tests;Immunologic;*Histocompatibility Testing;B-Lymphocytes/chemistry/*immunology;Complement C4b/*chemistry/immunology;Dithiothreitol/chemistry;HLA Antigens/*chemistry/immunology;Isoantibodies/*analysis/immunology;Peptide Fragments/*chemistry/immunology;T-Lymphocytes/chemistry/*immunology}
}

@ARTICLE{schenk2012hqll624632,
  author = {Schenk, P.~ and Warszawska, J.~ and Fuhrmann, V.~ and K{\"o}nig, F.~ and Madl, C.~ and Ratheiser, K.~},
  title = {Health-Related Quality of Life of Long-Term Survivors of Intensive Care: Changes after Intensive Care Treatment. Experience of an Austrian Intensive Care Unit.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2012},
  volume = {124},
  number = {17-18},
  pages = {624--632},
  issn = {1613-7671 0043-5325},
  doi = {10.1007/s00508-012-0224-z},
  keywords = {Female;Humans;Male;Middle Aged;Austria/epidemiology;Incidence;Longitudinal Studies;Survivors;Quality of Life/*psychology;Intensive Care Units/*statistics \& numerical data;Critical Care/*psychology/*statistics \& numerical data;Depression/*epidemiology/*psychology}
}

@ARTICLE{drolz2011hqlls25s25,
  author = {Drolz, A.~ and Warszawska, J.~ and Fuhrmann, V.~ and Ratheiser, K.~ and Fangl, M.~ and K{\"o}nig, F.~ and Wewalka, M.~ and Zauner, C.~ and Schenk, P.~},
  title = {Health-Related Quality of Life of Long-Term Survivors of Intensive Care—Changes after Intensive Care Treatment.},
  journal = {Intensive Care Medicine},
  year = {2011},
  volume = {37},
  number = {Suppl 1: Abstracts 24th Annual Congress of the European Society of Intensive Care Medicine ESICM LIVES 2011, Berlin, Germany, 1–5 October 2011},
  pages = {S25},
  url = {https://link.springer.com/content/pdf/10.1007%2Fs00134-011-2322-1.pdf#page=25}
}

@ARTICLE{gruberblum2011ctsa442449,
  author = {Gruber-Blum, S.~ and Petter-Puchner, A. H.~ and Brand, J.~ and Fortelny, R. H.~ and Walder, N.~ and Oehlinger, W.~ and Koenig, F.~ and Redl, H.~},
  title = {Comparison of Three Separate Antiadhesive Barriers for Intraperitoneal Onlay Mesh Hernia Repair in an Experimental Model.},
  journal = {British Journal of Surgery},
  year = {2011},
  volume = {98},
  number = {3},
  pages = {442--449},
  issn = {1365-2168 0007-1323},
  doi = {10.1002/bjs.7334},
  keywords = {Animals;Random Allocation;Rats;Rats;Wistar;*Surgical Mesh;Fibrin Tissue Adhesive/therapeutic use;Hernia;Abdominal/pathology/*surgery;Tissue Adhesions/*prevention \& control;Tissue Adhesives/therapeutic use}
}

@ARTICLE{manolis2011rmsp214221,
  author = {Manolis, E.~ and Osman Eldirdiry, T.~ and Herold, R.~ and Koenig, F.~ and Tomasi, P.~ and Vamvakas, S.~ and Saint Raymond, A.~},
  title = {Role of Modeling and Simulation in Pediatric Investigation Plans.},
  journal = {Paediatric Anaesthesia},
  year = {2011},
  volume = {21},
  number = {3},
  pages = {214--221},
  issn = {1460-9592 1155-5645},
  doi = {10.1111/j.1460-9592.2011.03523.x},
  keywords = {Humans;Databases;Factual;Child;Infant;Infant;Newborn;Research Design;Child;Preschool;*Models;Statistical;Pharmacokinetics;Drug Delivery Systems;Population;*Computer Simulation;Pediatrics/*statistics \& numerical data}
}

@ARTICLE{sieghart2011oepo8997,
  author = {Sieghart, W.~ and Wang, X.~ and Schmid, K.~ and Pinter, M.~ and K{\"o}nig, F.~ and Bodingbauer, M.~ and Wrba, F.~ and Rasoul-Rockenschaub, S.~ and Peck-Radosavljevic, M.~},
  title = {Osteopontin Expression Predicts Overall Survival after Liver Transplantation for Hepatocellular Carcinoma in Patients beyond the Milan Criteria.},
  journal = {Journal of Hepatology},
  year = {2011},
  volume = {54},
  number = {1},
  pages = {89--97},
  issn = {1600-0641 0168-8278},
  doi = {10.1016/j.jhep.2010.06.030},
  keywords = {Adult;Female;Humans;Male;Aged;Middle Aged;Prognosis;Multivariate Analysis;Proportional Hazards Models;Recurrence;Survival Analysis;Biomarkers;Tumor/metabolism;*Liver Transplantation;Carcinoma;Hepatocellular/*metabolism/mortality/*surgery;Liver Neoplasms/*metabolism/mortality/*surgery;Osteopontin/*metabolism}
}

@ARTICLE{schmid2010adrp574582,
  author = {Schmid, M.~ and Peck-Radosavljevic, M.~ and K{\"o}nig, F.~ and Mittermaier, C.~ and Gangl, A.~ and Ferenci, P.~},
  title = {A Double-Blind, Randomized, Placebo-Controlled Trial of Intravenous L-Ornithine-L-Aspartate on Postural Control in Patients with Cirrhosis.},
  journal = {Liver International},
  year = {2010},
  volume = {30},
  number = {4},
  pages = {574--582},
  issn = {1478-3231 1478-3223},
  doi = {10.1111/j.1478-3231.2010.02213.x},
  keywords = {Female;Humans;Male;Aged;Middle Aged;Reference Values;Survival Rate;Statistics;Nonparametric;Dose-Response Relationship;Drug;Double-Blind Method;Pilot Projects;Follow-Up Studies;Treatment Outcome;Risk Assessment;Severity of Illness Index;Immunohistochemistry;Infusions;Intravenous;Psychometrics;Liver Function Tests;Biopsy;Needle;Drug Administration Schedule;Ammonia/blood;Dipeptides/*administration \& dosage;Hepatic Encephalopathy/complications/drug therapy/mortality/pathology/psychology;Liver Cirrhosis/*complications/*drug therapy/mortality/pathology;Postural Balance/*drug effects;Sensation Disorders/*drug therapy/*etiology}
}

@ARTICLE{eichler2010rede277291,
  author = {Eichler, H.-G.~ and Bloechl-Daum, B.~ and Abadie, E.~ and Barnett, D.~ and K{\"o}nig, F.~ and Pearson, S.~},
  title = {Relative Efficacy of Drugs: An Emerging Issue between Regulatory Agencies and Third-Party Payers.},
  journal = {Nature Reviews Drug Discovery},
  year = {2010},
  volume = {9},
  number = {4},
  pages = {277--291},
  issn = {1474-1784 1474-1776},
  doi = {10.1038/nrd3079},
  keywords = {Humans;Time Factors;European Union;United States;Drug Design;*Insurance;Pharmaceutical Services;*Legislation;Drug;*Reimbursement Mechanisms;Drug Approval/economics/legislation \& jurisprudence;Insurance Carriers/trends;Pharmaceutical Preparations/economics/standards}
}

@ARTICLE{bauer2010sbhb113,
  author = {Bauer, P.~ and Koenig, F.~ and Brannath, W.~ and Posch, M.~},
  title = {Selection and Bias—Two Hostile Brothers.},
  journal = {Statistics in Medicine},
  year = {2010},
  volume = {29},
  number = {1},
  pages = {1--13},
  issn = {1097-0258 0277-6715},
  doi = {10.1002/sim.3716},
  keywords = {Humans;Area Under Curve;*Research Design;Sample Size;*Data Interpretation;Statistical;Randomized Controlled Trials as Topic/*methods;*Bias;Guanidines/administration \& dosage/therapeutic use;Myocardial Infarction/therapy;Sodium-Hydrogen Exchangers/antagonists \& inhibitors;Sulfones/administration \& dosage/therapeutic use}
}

@ARTICLE{regnstrom2010faws3948,
  author = {Regnstrom, J.~ and Koenig, F.~ and Aronsson, B.~ and Reimer, T.~ and Svendsen, K.~ and Tsigkos, S.~ and Flamion, B.~ and Eichler, H.-G.~ and Vamvakas, S.~},
  title = {Factors Associated with Success of Market Authorisation Applications for Pharmaceutical Drugs Submitted to the European Medicines Agency.},
  journal = {European Journal of Clinical Pharmacology},
  year = {2010},
  volume = {66},
  pages = {39--48},
  issn = {1432-1041 0031-6970},
  doi = {10.1007/s00228-009-0756-y},
  keywords = {Humans;Europe;*Pharmaceutical Preparations;Advisory Committees/organization \& administration;Drug Approval/legislation \& jurisprudence/*organization \& administration;Drug Industry/legislation \& jurisprudence/*organization \& administration;Government Agencies/*legislation \& jurisprudence;Legislation;Drug/*organization \& administration;Marketing/*legislation \& jurisprudence/organization \& administration}
}

@ARTICLE{frottier2009dvta376385,
  author = {Frottier, P.~ and Koenig, F.~ and Seyringer, M.~ and Matschnig, T.~ and Fruehwald, S.~},
  title = {The Distillation of “VISCI”: Towards a Better Identification of Suicidal Inmates.},
  journal = {Suicide and Life-Threatening Behavior},
  year = {2009},
  volume = {39},
  number = {4},
  pages = {376--385},
  issn = {0363-0234 0363-0234},
  doi = {https://onlinelibrary.wiley.com/doi/full/10.1521/suli.2009.39.4.376},
  keywords = {Humans;ROC Curve;Sensitivity and Specificity;Case-Control Studies;Reproducibility of Results;Austria;Matched-Pair Analysis;*Mass Screening;*Psychological Tests;Prisoners/*psychology;Suicide/*prevention \& control/psychology}
}

@ARTICLE{stallard2009ocnt13211338,
  author = {Stallard, N.~ and Posch, M.~ and Friede, T.~ and Koenig, F.~ and Brannath, W.~},
  title = {Optimal Choice of the Number of Treatments to Be Included in a Clinical Trial.},
  journal = {Statistics in Medicine},
  year = {2009},
  volume = {28},
  number = {9},
  pages = {1321--1338},
  note = {
[Erratum: Stallard N., Friede T., Posch M., Koenig F., Brannath W. Correction. Statistics in Medicine 29(5), 614–615, (2010)] },
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3551},
  keywords = {Algorithms;Humans;Models;Statistical;Sample Size;Bayes Theorem;Biometry;Decision Theory;Alzheimer Disease/drug therapy;Clinical Trials;Phase III as Topic/*statistics \& numerical data}
}

@ARTICLE{bretz2009adcc11811217,
  author = {Bretz, F.~ and Koenig, F.~ and Brannath, W.~ and Glimm, E.~ and Posch, M.~},
  title = {Adaptive Designs for Confirmatory Clinical Trials.},
  journal = {Statistics in Medicine},
  year = {2009},
  volume = {28},
  number = {8},
  pages = {1181--1217},
  note = {[Tutorial]},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3538},
  keywords = {Humans;*Research Design;Computer Simulation;Sample Size;Clinical Trials;Phase II as Topic/*methods;Clinical Trials;Phase III as Topic/*methods;Anti-Anxiety Agents/therapeutic use;Anxiety Disorders/drug therapy}
}

@ARTICLE{schmidschwap2009cfcd360368,
  author = {Schmid-Schwap, M.~ and Franz, A.~ and K{\"o}nig, F.~ and Bristela, M.~ and Lucas, T.~ and Piehslinger, E.~ and Watts, D. C.~ and Schedle, A.~},
  title = {Cytotoxicity of Four Categories of Dental Cements.},
  journal = {Dental Materials},
  year = {2009},
  volume = {25},
  number = {3},
  pages = {360--368},
  issn = {1879-0097 0109-5641},
  doi = {10.1016/j.dental.2008.08.002},
  keywords = {Animals;Time Factors;Mice;Cell Line;Culture Media;Cell Culture Techniques;Materials Testing;Cell Count;Dental Bonding;Acrylates/chemistry;Biocompatible Materials/toxicity;Fibroblasts/drug effects;Glass Ionomer Cements/chemistry;Phosphates/chemistry;Polycarboxylate Cement/chemistry;Resin Cements/chemistry/*toxicity;Resins;Synthetic/chemistry;Zinc Phosphate Cement/chemistry}
}

@ARTICLE{franz2009cedb232239,
  author = {Franz, A.~ and K{\"o}nig, F.~ and Lucas, T.~ and Watts, D. C.~ and Schedle, A.~},
  title = {Cytotoxic Effects of Dental Bonding Substances as a Function of Degree of Conversion.},
  journal = {Dental Materials},
  year = {2009},
  volume = {25},
  number = {2},
  pages = {232--239},
  issn = {1879-0097 0109-5641},
  doi = {10.1016/j.dental.2008.07.003},
  keywords = {Animals;Time Factors;Mice;Cell Line;Cell Culture Techniques;Cell Count;Fibroblasts/drug effects;*Dental Bonding;Acrylates/chemistry/toxicity;Biocompatible Materials/chemistry/toxicity;Composite Resins/chemistry/*toxicity;Dental Materials/chemistry/*toxicity;Dentin-Bonding Agents/chemistry/toxicity;Ethanol/chemistry/toxicity;Maleates/chemistry/toxicity;Materials Testing/*methods;Methacrylates/chemistry/toxicity;Phosphates/chemistry/toxicity;Polymethacrylic Acids/chemistry/toxicity;Resin Cements/chemistry/toxicity;Siloxanes/chemistry/toxicity;Terpenes/chemistry/toxicity}
}

@ARTICLE{angermayr2009aclh6571,
  author = {Angermayr, B.~ and Luca, A.~ and K{\"o}nig, F.~ and Bertolini, G.~ and Ploner, M.~ and Gridelli, B.~ and Ulbrich, G.~ and Reiberger, T.~ and Bosch, J.~ and Peck-Radosavljevic, M.~},
  title = {Aetiology of Cirrhosis of the Liver Has an Impact on Survival Predicted by the Model of End-Stage Liver Disease Score.},
  journal = {European Journal of Clinical Investigation},
  year = {2009},
  volume = {39},
  number = {1},
  pages = {65--71},
  issn = {0014-2972},
  doi = {10.1111/j.1365-2362.2008.02063.x},
  url = {https://doi.org/10.1111/j.1365-2362.2008.02063.x},
  keywords = {liver transplantation;Child-Pugh score;MELD;portal hypertension;prognostic scores;TIPS}
}

@ARTICLE{sarahrudi2009icff3641,
  author = {Sarahrudi, K.~ and Mousavi, M.~ and Grossschmidt, K.~ and Sela, N.~ and K{\"o}nig, F.~ and Vécsei, V.~ and Aharinejad, S.~},
  title = {The Impact of Colony-Stimulating Factor-1 on Fracture Healing: An Experimental Study.},
  journal = {Journal of Orthopaedic Research},
  year = {2009},
  volume = {27},
  number = {1},
  pages = {36--41},
  issn = {1554-527X 0736-0266},
  doi = {10.1002/jor.20680},
  keywords = {Animals;Female;Time Factors;Biomechanical Phenomena;Osteotomy;Bone Remodeling;Rabbits;Radiography;*Fracture Healing;Bone and Bones/pathology;Bone Regeneration/drug effects;Femoral Fractures/pathology/*therapy;Femur/diagnostic imaging/pathology;Macrophage Colony-Stimulating Factor/*metabolism/therapeutic use;Osteoblasts/cytology/metabolism;Osteoclasts/cytology/metabolism}
}

@ARTICLE{posch2008m5ic633635,
  author = {Posch, M.~ and Koenig, F.~ and Hsu, J.~},
  title = {MCP2007 – 5th International Conference on Multiple Comparison Procedures.},
  journal = {Biometrical Journal},
  year = {2008},
  volume = {50},
  number = {5},
  pages = {633--635},
  note = {[Editorial]},
  issn = {0323-3847},
  doi = {10.1002/bimj.200810458},
  url = {https://doi.org/10.1002/bimj.200810458}
}

@ARTICLE{jonke2008csbs495502,
  author = {Jonke, E.~ and Franz, A.~ and Freudenthaler, J.~ and K{\"o}nig, F.~ and Bantleon, H.-P.~ and Schedle, A.~},
  title = {Cytotoxicity and Shear Bond Strength of Four Orthodontic Adhesive Systems.},
  journal = {European Journal of Orthodontics},
  year = {2008},
  volume = {30},
  number = {5},
  pages = {495--502},
  issn = {1460-2210 0141-5387},
  doi = {10.1093/ejo/cjn042},
  keywords = {Animals;Humans;Mice;Dental Stress Analysis;Materials Testing;Shear Strength;L Cells (Cell Line);Fibroblasts/*drug effects;Resin Cements/*toxicity;*Dental Bonding;*Orthodontic Brackets}
}

@ARTICLE{fortelny2008aqla499505,
  author = {Fortelny, R. H.~ and Schwab, R.~ and Glaser, K. S.~ and Puchner, K. U.~ and May, C.~ and K{\"o}nig, F.~ and Redl, H.~ and Petter-Puchner, A. H.~},
  title = {The Assessment of Quality of Life in a Trial on Lightweight Mesh Fixation with Fibrin Sealant in Transabdominal Preperitoneal Hernia Repair.},
  journal = {Hernia},
  year = {2008},
  volume = {12},
  number = {5},
  pages = {499--505},
  issn = {1265-4906 1248-9204},
  doi = {10.1007/s10029-008-0365-1},
  keywords = {Humans;Quality of Life;Laparoscopy;Fibrin Tissue Adhesive/*administration \& dosage;Tissue Adhesives/*administration \& dosage;*Surgical Mesh;*Herniorrhaphy;Pain;Postoperative/prevention \& control}
}

@ARTICLE{weninger2008fraa799808,
  author = {Weninger, P.~ and Aldrian, S.~ and Koenig, F.~ and Vécsei, V.~ and Nau, T.~},
  title = {Functional Recovery at a Minimum of 2 Years after Multiple Injury—Development of an Outcome Score.},
  journal = {Journal of Trauma – Injury, Infection, and Critical Care},
  year = {2008},
  volume = {65},
  number = {4},
  pages = {799--808},
  issn = {1529-8809 0022-5282},
  doi = {10.1097/TA.0b013e3181820dae},
  keywords = {Female;Humans;Male;Time Factors;Cohort Studies;Prospective Studies;Observer Variation;Probability;Austria;Follow-Up Studies;Treatment Outcome;Confidence Intervals;Activities of Daily Living;Risk Assessment;Survival Analysis;Outcome Assessment (Health Care);Quality of Life;Regression Analysis;Combined Modality Therapy;Registries;Academic Medical Centers;Length of Stay;Trauma Centers;*Recovery of Function;*Abbreviated Injury Scale;Multiple Trauma/diagnosis/mortality/rehabilitation/*therapy;Survivors/statistics \& numerical data;Wounds and Injuries/diagnosis/mortality/rehabilitation/*therapy}
}

@ARTICLE{sarahrudi2008cabh759763,
  author = {Sarahrudi, K.~ and Mousavi, M.~ and Grossschmidt, K.~ and Sela, N.~ and K{\"o}nig, F.~ and Vécsei, V.~ and Aharinejad, S.~},
  title = {Combination of Anorganic Bovine-Derived Hydroxyapatite with Binding Peptide Does Not Enhance Bone Healing in a Critical-Size Defect in a Rabbit Model.},
  journal = {Journal of Orthopaedic Research},
  year = {2008},
  volume = {26},
  number = {6},
  pages = {759--763},
  issn = {1554-527X 0736-0266},
  doi = {10.1002/jor.20527},
  keywords = {Animals;Female;Drug Therapy;Combination;Osteotomy;Combined Modality Therapy;Disease Models;Animal;Cattle;Rabbits;Radiography;Bone Plates;*Prosthesis Failure;Biocompatible Materials/*pharmacology;Collagen/*pharmacology;Durapatite/*pharmacology;Femoral Fractures/diagnostic imaging/*drug therapy/*surgery;Peptide Fragments/*pharmacology}
}

@ARTICLE{koenig2008adtt16121625,
  author = {Koenig, F.~ and Brannath, W.~ and Bretz, F.~ and Posch, M.~},
  title = {Adaptive Dunnett Tests for Treatment Selection.},
  journal = {Statistics in Medicine},
  year = {2008},
  volume = {27},
  number = {10},
  pages = {1612--1625},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.3048},
  keywords = {Humans;*Research Design;Computer Simulation;Bias;Clinical Trials as Topic/*methods;Clinical Trials;Phase II as Topic/methods;Clinical Trials;Phase III as Topic/methods}
}

@ARTICLE{schmid2008prpts123s123,
  author = {Schmid, M.~ and K{\"o}nig, F.~ and Ferenci, P.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Prospective Randomized Pilot Trial of i.v. L-Ornithine-L-Aspartate (LOLA) vs. Placebo on Postural Control in Patients with Cirrhosis.},
  journal = {Journal of Hepatology},
  year = {2008},
  volume = {48},
  number = {Suppl 2: Abstracts 43rd Annual Meeting of the European Association for the Study of the Liver, Milan, Italy, 23–27 April 2008},
  pages = {S123},
  issn = {0168-8278},
  doi = {10.1016/S0168-8278(08)60312-8}
}

@ARTICLE{frottier2008dwife1e8,
  author = {Frottier, P.~ and K{\"o}nig, F.~ and Matschnig, T.~ and Seyringer, M.-E.~ and Fr{\"u}hwald, S.~},
  title = {Das Wiener Instrument f{\"u}r Suizidgefahr in Haft.},
  journal = {Psychiatrische Praxis},
  year = {2008},
  volume = {35},
  number = {01},
  pages = {e1--e8},
  issn = {0303-4259},
  doi = {10.1055/s-2007-970884}
}

@INPROCEEDINGS{koenig2008tsag7878,
  author = {K{\"o}nig, F.~ and Stallard, N.~ and Friede, T.~},
  title = {Treatment Selection in Adaptive Group-Sequential Designs.},
  booktitle = {Lifestat 2008 – Statistics and Life Sciences: Perspectives and Challenges. Abstracts of Talks and Posters of First Conference of the Central European Network, 54. Biometrisches Kolloquium, 25. ROeS Seminar, Munich, Germany, 10–13 March 2008},
  year = {2008},
  editor = {Hothorn,L.A.;Mansmann,U.;Tutz,G.;Burger,H.U.;Mejza,S.},
  pages = {78},
  address = {Hannover},
  publisher = {Deutsche Region der Internationalen Biometrischen Gesellschaft},
  doi = {http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/Landwirtschaft/tagungsberichte_pdf/lifestat2008_abstract_band.pdf#page=109}
}

@ARTICLE{fruehwald2007ejpss18s18,
  author = {Fr{\"u}hwald, S.~ and Seyringer, M.~ and Matschnig, T.~ and Frottier, P.~ and K{\"o}nig, F.~},
  title = {Epidemiology of Jail and Prison Suicides in Austria.},
  journal = {BMC Psychiatry},
  year = {2007},
  volume = {7},
  number = {Suppl 1: Abstracts World Psychiatric Association (WPA) Thematic Conference. Coercive Treatment in Psychiatry: A Comprehensive Review, Dresden, Germany, 6–8 June 2007},
  pages = {S18},
  issn = {1471-244X},
  doi = {10.1186/1471-244X-7-S1-S18},
  url = {https://doi.org/10.1186/1471-244X-7-S1-S18}
}

@ARTICLE{franz2007crca14381446,
  author = {Franz, A.~ and K{\"o}nig, F.~ and Skolka, A.~ and Sperr, W.~ and Bauer, P.~ and Lucas, T.~ and Watts, D. C.~ and Schedle, A.~},
  title = {Cytotoxicity of Resin Composites as a Function of Interface Area.},
  journal = {Dental Materials},
  year = {2007},
  volume = {23},
  number = {11},
  pages = {1438--1446},
  issn = {0109-5641 0109-5641},
  doi = {10.1016/j.dental.2007.05.014},
  keywords = {Animals;Humans;Mice;Culture Media;Analysis of Variance;Flow Cytometry;L Cells (Cell Line);Composite Resins/*toxicity;Fibroblasts/*drug effects;Gingiva/cytology/*drug effects;Resin Cements/*toxicity;Toxicity Tests/methods}
}

@ARTICLE{schmidschwap2007cevc596598,
  author = {Schmid-Schwap, M.~ and Franz, A.~ and Krainh{\"o}fner, M.~ and K{\"o}nig, F.~ and Krennmair, G.~ and Schedle, A.~},
  title = {Cytotoxic Effects of Veneer Composite Materials.},
  journal = {International Journal of Prosthodontics},
  year = {2007},
  volume = {20},
  number = {6},
  pages = {596--598},
  note = {[Brief Communication]},
  issn = {0893-2174 0893-2174},
  doi = {https://ijp.quintessenz.de/index.php?doc=toc\&year=2007\&issue=6},
  url = {https://ijp.quintessenz.de/18d7/ijp_2007_06_s0596.pdf},
  keywords = {Animals;Mice;L Cells (Cell Line);Composite Resins/*toxicity;Dental Veneers/*adverse effects}
}

@ARTICLE{bornkamp2007iada965995,
  author = {Bornkamp, B.~ and Bretz, F.~ and Dmitrienko, A.~ and Enas, G.~ and Gaydos, B.~ and Hsu, C.-H.~ and K{\"o}nig, F.~ and Krams, M.~ and Liu, Q.~ and Neuenschwander, B.~ and Parke, T.~ and Pinheiro, J.~ and Roy, A.~ and Sax, R.~ and Shen, F.~},
  title = {Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials.},
  journal = {Journal of Biopharmaceutical Statistics},
  year = {2007},
  volume = {17},
  number = {6},
  pages = {965--995},
  issn = {1054-3406 1054-3406},
  doi = {10.1080/10543400701643848},
  keywords = {Humans;Dose-Response Relationship;Drug;*Research Design;Sample Size;*Data Interpretation;Statistical;Clinical Trials as Topic/*methods/statistics \& numerical data;*Drug Industry}
}

@ARTICLE{angermayr2007pmap591a591a,
  author = {Angermayr, B.~ and Brannath, W.~ and Ulbrich, G.~ and Koenig, F.~ and Spangl, W.~ and Peck-Radosavljevic, M.~},
  title = {Particulate Matter as Potential Trigger for Esophageal Variceal Bleeding in Patients with Cirrhosis of the Liver.},
  journal = {Hepatology},
  year = {2007},
  volume = {46},
  number = {4, Suppl 1: Abstracts 58th Annual Meeting of the American Association for the Study of Liver Diseases, Boston, MA, USA, 2–6 November 2007},
  pages = {591A},
  issn = {0270-9139},
  doi = {10.1002/hep.22019}
}

@ARTICLE{aldrian2007cppb10591064,
  author = {Aldrian, S.~ and Koenig, F.~ and Weninger, P.~ and Vécsei, V.~ and Nau, T.~},
  title = {Characteristics of Polytrauma Patients between 1992 and 2002: What Is Changing?},
  journal = {Injury},
  year = {2007},
  volume = {38},
  number = {9},
  pages = {1059--1064},
  issn = {0020-1383 0020-1383},
  doi = {10.1016/j.injury.2007.04.022},
  keywords = {Adolescent;Adult;Female;Humans;Male;Retrospective Studies;Middle Aged;Prospective Studies;Age Factors;Prevalence;Injury Severity Score;Intubation/statistics \& numerical data;Multiple Organ Failure/epidemiology/*mortality/prevention \& control;Respiratory Distress Syndrome;Adult/epidemiology/*mortality/prevention \& control;Traumatology/trends}
}

@ARTICLE{brannath2007swpb651653,
  author = {Brannath, W.~ and K{\"o}nig, F.~ and Posch, M.~},
  title = {The Scientific Work of Peter Bauer.},
  journal = {Biometrical Journal},
  year = {2007},
  volume = {49},
  number = {5},
  pages = {651--653},
  issn = {0323-3847 0323-3847},
  doi = {10.1002/bimj.200710381},
  keywords = {Austria;History;20th Century;History;21st Century;Biometry/*history;Computational Biology/*history;Science/*history}
}

@ARTICLE{luca2007immi11741180,
  author = {Luca, A.~ and Angermayr, B.~ and Bertolini, G.~ and Koenig, F.~ and Vizzini, G.~ and Ploner, M.~ and Peck-Radosavljevic, M.~ and Gridelli, B.~ and Bosch, J.~},
  title = {An Integrated MELD Model Including Serum Sodium and Age Improves the Prediction of Early Mortality in Patients with Cirrhosis.},
  journal = {Liver Transplantation},
  year = {2007},
  volume = {13},
  number = {8},
  pages = {1174--1180},
  issn = {1527-6465 1527-6465},
  doi = {10.1002/lt.21197},
  keywords = {Adult;Female;Humans;Male;Retrospective Studies;Middle Aged;Cohort Studies;Prospective Studies;Models;Statistical;Models;Theoretical;Multivariate Analysis;Proportional Hazards Models;Treatment Outcome;Europe;Risk;Prothrombin Time;Fibrosis/*blood/*mortality/surgery;Liver Transplantation/*methods;Serum Albumin/biosynthesis;Sodium/*blood}
}

@ARTICLE{frottier2007spci225232,
  author = {Frottier, P.~ and K{\"o}nig, F.~ and Matschnig, T.~ and Seyringer, M.-E.~ and Fr{\"u}hwald, S.~},
  title = {Suicide Prevention in Correctional Institutions: The Significance of Solitary Cell Accommodation.},
  journal = {International Journal of Prisoner Health},
  year = {2007},
  volume = {3},
  number = {3},
  pages = {225--232},
  doi = {10.1080/17449200701520206},
  url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-34547206250\&doi=10.1080%2f17449200701520206\&partnerID=40\&md5=79d0d281934e7fe9588a782f41e26b9d}
}

@ARTICLE{brannath2007mfct205216,
  author = {Brannath, W.~ and Koenig, F.~ and Bauer, P.~},
  title = {Multiplicity and Flexibility in Clinical Trials.},
  journal = {Pharmaceutical Statistics},
  year = {2007},
  volume = {6},
  number = {3},
  pages = {205--216},
  issn = {1539-1604 1539-1604},
  doi = {10.1002/pst.302},
  keywords = {Humans;Models;Statistical;Endpoint Determination;*Research Design;Sample Size;Bias;*Data Interpretation;Statistical;Drug Design;Clinical Trials as Topic/*methods}
}

@INPROCEEDINGS{koenig2007uctf4242,
  author = {Koenig, F.~ and Bauer, P.~ and Brannath, W.~},
  title = {On the Use of Conventional Tests in Flexible, Multiple Test Designs.},
  booktitle = {MCP 2007 – Vienna, 5th International Conference on Multiple Comparison Procedures, Vienna, Austria, 8–11 July 2007, Program and Abstracts},
  year = {2007},
  editor = {Posch,M.;Hsu,J.;K{\"o}nig,F.},
  pages = {42},
  address = {Vienna, Austria},
  publisher = {Section of Medical Statistics, Medical University of Vienna},
  url = {http://www.mcp-conference.org/2007/downloads/MCP_2007_AbstractBook.pdf#page=44}
}

@ARTICLE{brannath2006efts33663381,
  author = {Brannath, W.~ and K{\"o}nig, F.~ and Bauer, P.~},
  title = {Estimation in Flexible Two Stage Designs.},
  journal = {Statistics in Medicine},
  year = {2006},
  volume = {25},
  number = {19},
  pages = {3366--3381},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.2258},
  keywords = {Humans;*Research Design;Sample Size;Clinical Trials as Topic/*methods}
}

@ARTICLE{angermayr2006echi453a454a,
  author = {Angermayr, B.~ and Luca, A.~ and Koenig, F.~ and Bertolini, G.~ and Ploner, M.~ and Cejna, M.~ and Bosch, J.~ and Peck-Radosavljevic, M.~},
  title = {Etiology of Cirrhosis Has an Impact on Survival Predicted by MELD-Score.},
  journal = {Hepatology},
  year = {2006},
  volume = {44},
  number = {4, Suppl 1: Abstracts 57th Annual Meeting of the American Association for the Study of Liver Diseases, Boston, MA, USA, 27–31 October 2006},
  pages = {453A--454A},
  issn = {0270-9139},
  doi = {10.1002/hep.21397}
}

@ARTICLE{fruehwald2006iwda250256,
  author = {Fr{\"u}hwald, S.~ and B{\"u}hler, B.~ and Grasl, R.~ and Gebetsberger, M.~ and Matschnig, T.~ and K{\"o}nig, F.~ and Frottier, P.~},
  title = {(Irr-) Wege in die Arbeitswelt – Langzeitergebnisse arbeitsrehabilitativer Einrichtungen f{\"u}r psychisch Kranke der Caritas St. P{\"o}lten.},
  journal = {Neuropsychiatrie},
  year = {2006},
  volume = {20},
  number = {4},
  pages = {250--256},
  issn = {0948-6259},
  url = {https://www.springer.com/cda/content/document/cda_downloaddocument/heft_20_4.pdf},
  keywords = {https://doi.org/10.5414/NEPBand20250}
}

@ARTICLE{bretz2006cspi623634,
  author = {Bretz, F.~ and Schmidli, H.~ and K{\"o}nig, F.~ and Racine, A.~ and Maurer, W.~},
  title = {Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {623--634},
  issn = {0323-3847 0323-3847},
  doi = {10.1002/bimj.200510232},
  keywords = {Data Interpretation;Statistical;Sample Size;Clinical Trials;Phase III as Topic/*statistics \& numerical data;*Biometry;Clinical Trials;Phase II as Topic/*statistics \& numerical data}
}

@ARTICLE{bretz2006r660662,
  author = {Bretz, F.~ and Schmidli, H.~ and K{\"o}nig, F.~ and Racine, A.~ and Maurer, W.~},
  title = {Rejoinder.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {660--662},
  note = {[Correspondence] [Re Re Re]},
  issn = {0323-3847},
  doi = {10.1002/bimj.200610255},
  url = {https://doi.org/10.1002/bimj.200610255},
  keywords = {Multiple testing;Closure principle;Adaptive seamless design;Adaptive tests;Combination tests;Hypotheses selection}
}

@ARTICLE{koenig2006ahtp663678,
  author = {K{\"o}nig, F.~ and Bauer, P.~ and Brannath, W.~},
  title = {An Adaptive Hierarchical Test Procedure for Selecting Safe and Efficient Treatments.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {663--678},
  issn = {0323-3847 0323-3847},
  doi = {10.1002/bimj.200510235},
  keywords = {Data Interpretation;Statistical;*Models;Statistical;Research Design/*statistics \& numerical data;*Biometry;*Factor Analysis;Statistical}
}

@ARTICLE{koenig2006r693694,
  author = {Koenig, F.~ and Bauer, P.~ and Brannath, W.~},
  title = {Rejoinder.},
  journal = {Biometrical Journal},
  year = {2006},
  volume = {48},
  number = {4},
  pages = {693--694},
  note = {[Correspondence] [Re]},
  issn = {0323-3847},
  doi = {10.1002/bimj.200610256}
}

@ARTICLE{aldrian2006mppd9397,
  author = {Aldrian, S.~ and Nau, T.~ and Koenig, F.~ and Weninger, P.~ and Vécsei, V.~},
  title = {Management of Polytrauma Patients during 10 Years.},
  journal = {Osteosynthesis and Trauma Care},
  year = {2006},
  volume = {14},
  number = {2},
  pages = {93--97},
  issn = {1618-971X},
  doi = {10.1055/s-2006-933398}
}

@ARTICLE{franz2006caca18,
  author = {Franz, A.~ and Konradsson, K.~ and K{\"o}nig, F.~ and Van Dijken, J. W. V.~ and Schedle, A.~},
  title = {Cytotoxicity of a Calcium Aluminate Cement in Comparison with Other Dental Cements and Resin-Based Materials.},
  journal = {Acta Odontologica Scandinavica},
  year = {2006},
  volume = {64},
  number = {1},
  pages = {1--8},
  issn = {0001-6357 0001-6357},
  doi = {10.1080/00016350500279568},
  keywords = {Animals;Mice;Analysis of Variance;Flow Cytometry;Aluminum Compounds/*toxicity;Calcium Compounds/*toxicity;Composite Resins/toxicity;Dental Cements/*toxicity;Dental Restoration;Permanent/methods;Glass Ionomer Cements/toxicity;L Cells (Cell Line)/drug effects;Resin Cements/toxicity;Zinc Phosphate Cement/toxicity}
}

@ARTICLE{bauer2006rtpi2336,
  author = {Bauer, P.~ and Koenig, F.~},
  title = {The Reassessment of Trial Perspectives from Interim Data—A Critical View.},
  journal = {Statistics in Medicine},
  year = {2006},
  volume = {25},
  number = {1},
  pages = {23--36},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.2180},
  keywords = {Humans;Sample Size;*Models;Statistical;*Data Interpretation;Statistical;Clinical Trials as Topic/*methods}
}

@ARTICLE{posch2005tefg36973714,
  author = {Posch, M.~ and Koenig, F.~ and Branson, M.~ and Brannath, W.~ and Dunger-Baldauf, C.~ and Bauer, P.~},
  title = {Testing and Estimation in Flexible Group Sequential Designs with Adaptive Treatment Selection.},
  journal = {Statistics in Medicine},
  year = {2005},
  volume = {24},
  number = {24: Special Issue: Papers from the 25th Annual Conference of the International Society for Clinical Biostatistics, Leiden, The Netherlands, 15–19 August 2004},
  pages = {3697--3714},
  issn = {0277-6715 0277-6715},
  doi = {10.1002/sim.2389},
  keywords = {Humans;Models;Statistical;Austria;*Research Design;Confidence Intervals;*Clinical Trials as Topic;Therapies;Investigational/*statistics \& numerical data}
}

@INPROCEEDINGS{koenig2005ahtp22,
  author = {K{\"o}nig, F.~ and Bauer, P.~ and Brannath, W.~},
  title = {An Adaptive Hierarchical Test Procedure after Selecting Safe and Efficient Treatments.},
  booktitle = {Abstracts 10th Young Statisticians Meeting, Seggau, Austria, 4–6 November 2005},
  year = {2005},
  pages = {2},
  address = {Graz, Austria},
  publisher = {Institute for Statistics, Technical University Graz},
  note = {Available at: http://www.stat.tugraz.at/ysm10/AKoenig.pdf},
  url = {http://www.stat.tugraz.at/ysm10/AKoenig.pdf}
}

@INPROCEEDINGS{koenig2005asmt,
  author = {K{\"o}nig, F.~ and Bauer, P.~ and Brannath, W.~},
  title = {Adaptive Selection and Multiple Testing of Effective and Safe Treatments.},
  booktitle = {Online-Abstracts ROeS Seminar 2005, Graz, Austria, 25–29 September 2005},
  year = {2005},
  address = {Graz, Austria},
  publisher = {Institut f{\"u}r Statistik, Technische Universit{\"a}t Graz},
  note = {Available at: http://www.stat.tugraz.at/ROeS2005/Koenig.pdf},
  url = {http://www.stat.tugraz.at/ROeS2005/Koenig.pdf}
}

@ARTICLE{reisinger2005ania347354,
  author = {Reisinger, J.~ and Horak, F.~ and Pauli, G.~ and van Hage, M.~ and Cromwell, O.~ and K{\"o}nig, F.~ and Valenta, R.~ and Niederberger, V.~},
  title = {Allergen-Specific Nasal IgG Antibodies Induced by Vaccination with Genetically Modified Allergens Are Associated with Reduced Nasal Allergen Sensitivity.},
  journal = {Journal of Allergy and Clinical Immunology},
  year = {2005},
  volume = {116},
  number = {2},
  pages = {347--354},
  issn = {0091-6749 0091-6749},
  doi = {10.1016/j.jaci.2005.04.003},
  keywords = {Adult;Female;Humans;Male;Middle Aged;Double-Blind Method;Allergens/*immunology;Antigens;Plant;Vaccination;*Desensitization;Immunologic;Immunoglobulin G/*biosynthesis/classification;Nasal Mucosa/*immunology;Plant Proteins/*immunology;Recombinant Proteins/immunology;Vaccines;Synthetic/*immunology}
}

@ARTICLE{weninger2005pule559566,
  author = {Weninger, P.~ and Trimmel, H.~ and Nau, T.~ and Aldrian, S.~ and K{\"o}nig, F.~ and Vécsei, V.~},
  title = {Polytrauma und Luftrettung. Eine  retrospektive Analyse der Versorgung im Osten {\"O}sterreichs am Beispiel eines urbanen Traumazentrums.},
  journal = {Unfallchirurg},
  year = {2005},
  volume = {108},
  number = {7},
  pages = {559--566},
  issn = {1433-044X},
  doi = {10.1007/s00113-005-0949-5},
  url = {https://doi.org/10.1007/s00113-005-0949-5}
}

@ARTICLE{reisinger2005iapa973981,
  author = {Reisinger, J.~ and Triendl, A.~ and K{\"u}chler, E.~ and Bohle, B.~ and Krauth, M. T.~ and Rauter, I.~ and Valent, P.~ and Koenig, F.~ and Valenta, R.~ and Niederberger, V.~},
  title = {IFN-γ-Enhanced Allergen Penetration across Respiratory Epithelium Augments Allergic Inflammation.},
  journal = {Journal of Allergy and Clinical Immunology},
  year = {2005},
  volume = {115},
  number = {5},
  pages = {973--981},
  issn = {0091-6749 0091-6749},
  doi = {10.1016/j.jaci.2005.01.021},
  keywords = {Humans;Time Factors;Pollen/immunology;Bronchi;Allergens/*metabolism;Basophils/drug effects/metabolism;Betula/immunology;Biological Transport/drug effects;Epithelial Cells/*drug effects/metabolism;Histamine/metabolism;Inflammation/immunology;Interferon-gamma/*pharmacology;Recombinant Proteins/metabolism;Th1 Cells/immunology}
}

@ARTICLE{aldrian2005gp145149,
  author = {Aldrian, S.~ and Nau, T.~ and Koenig, F.~ and Vécsei, V.~},
  title = {Geriatric Polytrauma.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2005},
  volume = {117},
  number = {4},
  pages = {145--149},
  issn = {0043-5325 0043-5325},
  url = {https://link.springer.com/article/10.1007/s00508-004-0290-y},
  keywords = {Adolescent;Adult;Female;Humans;Male;Risk Factors;Aged;Middle Aged;Aged;80 and over;Austria/epidemiology;Incidence;Prognosis;Treatment Outcome;Comorbidity;Age Distribution;Outcome Assessment (Health Care)/*methods;Risk Assessment/*methods;Intubation/statistics \& numerical data;Emergency Medical Services/*statistics \& numerical data;Health Services for the Aged/*statistics \& numerical data;Multiple Organ Failure/*mortality;Multiple Trauma/*mortality/*surgery/therapy}
}

@ARTICLE{ossege2005eira8187,
  author = {Ossege, M.~ and Sycha, T.~ and Aigner, M.~ and Schmetterer, L.~ and Eichler, H.-G.~ and M{\"u}ller, M.~ and K{\"o}nig, F.~ and Bauer, P.~},
  title = {Effect of Information on Reported Adverse Events in a Placebo-Controlled Trial.},
  journal = {Drug Safety},
  year = {2005},
  volume = {28},
  number = {1},
  pages = {81--87},
  issn = {0114-5916 0114-5916},
  doi = {10.2165/00002018-200528010-00006},
  keywords = {Adult;Female;Humans;Male;Middle Aged;Double-Blind Method;Cross-Over Studies;Severity of Illness Index;Pain Measurement;*Communication;Calcium Channel Blockers/*adverse effects;Nifedipine/*adverse effects;Placebos/*adverse effects}
}

@ARTICLE{fruehwald2004sccs494498,
  author = {Fruehwald, S.~ and Matschnig, T.~ and Koenig, F.~ and Bauer, P.~ and Frottier, P.~},
  title = {Suicide in Custody: Case–Control Study.},
  journal = {British Journal of Psychiatry},
  year = {2004},
  volume = {185},
  number = {6},
  pages = {494--498},
  issn = {0007-1250 0007-1250},
  doi = {10.1192/bjp.185.6.494},
  keywords = {Adolescent;Adult;Female;Humans;Male;Risk Factors;Aged;Middle Aged;Case-Control Studies;Austria/epidemiology;Regression Analysis;Mental Disorders/*epidemiology;Prisoners/*statistics \& numerical data;Suicide/*statistics \& numerical data}
}

@ARTICLE{angermayr2004tips608613,
  author = {Angermayr, B.~ and Cejna, M.~ and Karnel, F.~ and Gschwantler, M.~ and K{\"o}nig, F.~ and Pidlich, J.~ and Mendel, H.~ and Brunner, H.~ and Pichler, L.~ and Ferenci, P.~ and Lammer, J.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Transjugular Intrahepatic Portosystemic Shunt in Vienna – A Decade Later.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2004},
  volume = {116},
  number = {17-18},
  pages = {608--613},
  issn = {0043-5325 0043-5325},
  doi = {10.1007/s00508-004-0207-9},
  keywords = {Adolescent;Adult;Female;Humans;Male;Retrospective Studies;Time Factors;Aged;Middle Aged;Aged;80 and over;Follow-Up Studies;Child;Data Interpretation;Statistical;Infant;Child;Preschool;Patient Selection;*Portasystemic Shunt;Transjugular Intrahepatic;Ascites/therapy;Esophageal and Gastric Varices/complications;Gastrointestinal Hemorrhage/prevention \& control/therapy;Hypertension;Portal/complications;Liver Cirrhosis/complications}
}

@ARTICLE{posch2004crps389403,
  author = {Posch, M.~ and Timmesfeld, N.~ and K{\"o}nig, F.~ and M{\"u}ller, H.-H.~},
  title = {Conditional Rejection Probabilities of Student’s t-Test and Design Adaptations.},
  journal = {Biometrical Journal},
  year = {2004},
  volume = {46},
  number = {4},
  pages = {389--403},
  issn = {0323-3847},
  doi = {10.1002/bimj.200410042},
  url = {https://doi.org/10.1002/bimj.200410042},
  keywords = {t-test;Adaptive designs;Conditional rejection probabilities;Design adaptions;Nonstochastic curtailment;Stochastic curtailment}
}

@ARTICLE{stifter2004rpdt12591267,
  author = {Stifter, E.~ and Sacu, S.~ and Weghaupt, H.~ and K{\"o}nig, F.~ and Richter-M{\"u}ksch, S.~ and Thaler, A.~ and Velikay-Parel, M.~ and Radner, W.~},
  title = {Reading Performance Depending on the Type of Cataract and Its Predictability on the Visual Outcome.},
  journal = {Journal of Cataract and Refractive Surgery},
  year = {2004},
  volume = {30},
  number = {6},
  pages = {1259--1267},
  issn = {0886-3350 0886-3350},
  doi = {10.1016/j.jcrs.2003.11.051},
  keywords = {Humans;Aged;Middle Aged;Prospective Studies;Visual Acuity;Phacoemulsification;*Reading;Cataract/classification/*physiopathology;Vision Disorders/physiopathology;Vision Tests/instrumentation}
}

@ARTICLE{bauer2004sirf6363,
  author = {Bauer, P.~ and K{\"o}nig, F.~},
  title = {S29.1: Interim Results, Flexibility and Inefficiency.},
  journal = {Biometrical Journal},
  year = {2004},
  volume = {46},
  number = {Suppl 1: Abstracts Joint Meeting of the German Region of the International Biometric Society (50th Meeting) and the German Association of Epidemiology (11th Meeting), Heidelberg, Germany, 16–19 March 2004},
  pages = {63},
  doi = {10.1002/bimj.200490115}
}

@ARTICLE{stifter2004rasr3139,
  author = {Stifter, E.~ and K{\"o}nig, F.~ and Lang, T.~ and Bauer, P.~ and Richter-M{\"u}ksch, S.~ and Velikay-Parel, M.~ and Radner, W.~},
  title = {Reliability of a Standardized Reading Chart System: Variance Component Analysis, Test-Retest and Inter-Chart Reliability.},
  journal = {Graefe’s Archive for Clinical and Experimental Ophthalmology},
  year = {2004},
  volume = {242},
  number = {1},
  pages = {31--39},
  issn = {0721-832X 0721-832X},
  doi = {10.1007/s00417-003-0776-8},
  keywords = {Female;Humans;Male;Aged;Reproducibility of Results;Random Allocation;Visual Acuity/*physiology;*Reading;Contrast Sensitivity/physiology;Vision Tests/instrumentation/*standards}
}

@ARTICLE{fruehwald2004dmos263269,
  author = {Fruehwald, S.~ and Frottier, P.~ and Matschnig, T.~ and Koenig, F.~ and Lehr, S.~ and Eher, R.~},
  title = {Do Monthly or Seasonal Variations Exist in Suicides in a High-Risk Setting?},
  journal = {Psychiatry Research},
  year = {2004},
  volume = {121},
  number = {3},
  pages = {263--269},
  issn = {0165-1781 0165-1781},
  doi = {10.1016/S0165-1781(03)00253-1},
  keywords = {*Seasons;Humans;Retrospective Studies;Austria/epidemiology;Cross-Sectional Studies;Risk;Poisson Distribution;Regression Analysis;Causality;Cause of Death;Periodicity;Prisoners/psychology/*statistics \& numerical data;Prisons/*statistics \& numerical data;Suicide/psychology/*statistics \& numerical data/trends}
}

@ARTICLE{nau2003fffm10181021,
  author = {Nau, T.~ and Aldrian, S.~ and Koenig, F.~ and Vécsei, V.~},
  title = {Fixation of Femoral Fractures in Multiple-Injury Patients with Combined Chest and Head Injuries.},
  journal = {ANZ Journal of Surgery},
  year = {2003},
  volume = {73},
  number = {12},
  pages = {1018--1021},
  issn = {1445-1433 1445-1433},
  doi = {10.1046/j.1445-2197.2003.t01-19-.x},
  keywords = {Adolescent;Adult;Female;Humans;Male;Aged;Prospective Studies;Aged;80 and over;Injury Severity Score;*Craniocerebral Trauma/complications/mortality;*Fracture Fixation;*Multiple Trauma/mortality;*Thoracic Injuries/complications/mortality;*Wounds;Nonpenetrating/complications/mortality;Femoral Fractures/complications/mortality/*surgery}
}

@ARTICLE{schopper2003fffa743749,
  author = {Schopper, C.~ and Moser, D.~ and Sabbas, A.~ and Lagogiannis, G.~ and Spassova, E.~ and K{\"o}nig, F.~ and Donath, K.~ and Ewers, R.~},
  title = {The Fluorohydroxyapatite (FHA) FRIOS® Algipore® Is a Suitable Biomaterial for the Reconstruction of Severely Atrophic Human Maxillae.},
  journal = {Clinical Oral Implants Research},
  year = {2003},
  volume = {14},
  number = {6},
  pages = {743--749},
  issn = {0905-7161 0905-7161},
  doi = {10.1046/j..2003.00959.x},
  keywords = {Adult;Female;Humans;Male;Aged;Middle Aged;Reconstructive Surgical Procedures/*methods;Atrophy;Osseointegration;Bone Regeneration;Alveolar Ridge Augmentation/*methods;*Biocompatible Materials;Alveolar Bone Loss/*pathology/surgery;Bone Substitutes/*therapeutic use;Dental Implantation;Endosseous/methods;Hydroxyapatites/*therapeutic use;Maxilla/*pathology/surgery;Maxillary Diseases/pathology/surgery;Maxillary Sinus/pathology/surgery}
}

@ARTICLE{angermayr2003sput10431050,
  author = {Angermayr, B.~ and Cejna, M.~ and Koenig, F.~ and Karnel, F.~ and Hackl, F.~ and Gangl, A.~ and Peck-Radosavljevic, M.~ and {for the Vienna TIPS Study Group}},
  title = {Survival in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt: ePTFE-Covered Stentgrafts versus Bare Stents.},
  journal = {Hepatology},
  year = {2003},
  volume = {38},
  number = {4},
  pages = {1043--1050},
  issn = {0270-9139 0270-9139},
  doi = {10.1053/jhep.2003.50423},
  keywords = {Adult;Female;Humans;Male;Retrospective Studies;Aged;Middle Aged;Proportional Hazards Models;Survival Analysis;*Polytetrafluoroethylene;*Stents;Portasystemic Shunt;Transjugular Intrahepatic/*mortality}
}

@ARTICLE{franz2003cepn382392,
  author = {Franz, A.~ and K{\"o}nig, F.~ and Anglmayer, M.~ and Rausch-Fan, X.~ and Gille, G.~ and Rausch, W.-D.~ and Lucas, T.~ and Sperr, W.~ and Schedle, A.~},
  title = {Cytotoxic Effects of Packable and Nonpackable Dental Composites.},
  journal = {Dental Materials},
  year = {2003},
  volume = {19},
  number = {5},
  pages = {382--392},
  issn = {0109-5641 0109-5641},
  doi = {10.1016/S0109-5641(02)00081-7},
  keywords = {Animals;Dose-Response Relationship;Drug;Mice;Dental Restoration;Permanent;L Cells (Cell Line);Composite Resins/*toxicity;Fibroblasts/*drug effects;Dopamine/metabolism;Methacrylates/toxicity;Neurons/*drug effects/metabolism;Siloxanes/toxicity;Terpenes/toxicity;Tyrosine 3-Monooxygenase/metabolism}
}

@ARTICLE{brunthaler2003ldrc6370,
  author = {Brunthaler, A.~ and K{\"o}nig, F.~ and Lucas, T.~ and Sperr, W.~ and Schedle, A.~},
  title = {Longevity of Direct Resin Composite Restorations in Posterior Teeth.},
  journal = {Clinical Oral Investigations},
  year = {2003},
  volume = {7},
  number = {2},
  pages = {63--70},
  issn = {1432-6981 1432-6981},
  doi = {10.1007/s00784-003-0206-7},
  keywords = {Humans;Linear Models;Time Factors;Prospective Studies;Follow-Up Studies;Randomized Controlled Trials as Topic;Dental Restoration Failure;Molar;Dental Bonding;Bicuspid;Dental Cavity Lining;*Dental Restoration;Permanent/methods/statistics \& numerical data;Composite Resins/*chemistry;Dental Caries/physiopathology}
}

@ARTICLE{angermayr2003cvms879885,
  author = {Angermayr, B.~ and Cejna, M.~ and Karnel, F.~ and Gschwantler, M.~ and Koenig, F.~ and Pidlich, J.~ and Mendel, H.~ and Pichler, L.~ and Wichlas, M.~ and Kreil, A.~ and Schmid, M.~ and Ferlitsch, A.~ and Lipinski, E.~ and Brunner, H.~ and Lammer, J.~ and Ferenci, P.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Child-Pugh versus MELD Score in Predicting Survival in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt.},
  journal = {Gut},
  year = {2003},
  volume = {52},
  number = {6},
  pages = {879--885},
  issn = {0017-5749 0017-5749},
  doi = {10.1136/gut.52.6.879},
  keywords = {Adult;Female;Humans;Male;Retrospective Studies;Risk Factors;Aged;Middle Aged;Prognosis;Proportional Hazards Models;Follow-Up Studies;Treatment Outcome;Survival Analysis;*Health Status Indicators;*Portasystemic Shunt;Transjugular Intrahepatic;Hepatitis;Viral;Human/surgery;Liver Cirrhosis;Alcoholic/surgery}
}

@ARTICLE{brannath2003ircb311324,
  author = {Brannath, W.~ and K{\"o}nig, F.~ and Bauer, P.~},
  title = {Improved Repeated Confidence Bounds in Trials with a Maximal Goal.},
  journal = {Biometrical Journal},
  year = {2003},
  volume = {45},
  number = {3},
  pages = {311--324},
  issn = {0323-3847},
  doi = {10.1002/bimj.200390014},
  url = {https://doi.org/10.1002/bimj.200390014},
  keywords = {Adaptive design;Monitoring;Flexible design;Repeated confidence interval;Clinical trial;Exhausting the level;Group sequential design}
}

@ARTICLE{angermayr2003sputa734a734,
  author = {Angermayr, B.~ and Cejna, M.~ and Karnel, F.~ and Koenig, F.~ and Hackl, F.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Survival of Patients Undergoing TIPS: ePTFE-Covered Stent-Grafts vs. Bare-Stents.},
  journal = {Gastroenterology},
  year = {2003},
  volume = {124},
  number = {4, Suppl 1: Abstracts Digestive Disease Week and 104th Annual Meeting of the American Gastroenterological Association, Orlando, FL, USA, 17–22 May 2003},
  pages = {A734},
  issn = {0016-5085},
  doi = {10.1016/S0016-5085(03)83709-5},
  url = {https://doi.org/10.1016/S0016-5085(03)83709-5}
}

@ARTICLE{nau2003eafs365369,
  author = {Nau, T.~ and Kutscha-Lissberg, F.~ and Muellner, T.~ and Koenig, F.~ and Vecsei, V.~},
  title = {Effects of a Femoral Shaft Fracture on Multiply Injured Patients with a Head Injury.},
  journal = {World Journal of Surgery},
  year = {2003},
  volume = {27},
  number = {3},
  pages = {365--369},
  issn = {0364-2313 0364-2313},
  doi = {10.1007/s00268-002-6412-7},
  keywords = {Adolescent;Adult;Female;Humans;Male;Aged;Middle Aged;Comorbidity;Injury Severity Score;Length of Stay;Fracture Fixation;Intramedullary;Hemodynamics;Craniocerebral Trauma/*epidemiology;Femoral Fractures/*epidemiology/surgery;Multiple Trauma/*epidemiology}
}

@ARTICLE{kucerasliutz2002vegf32313234,
  author = {Kucera-Sliutz, E.~ and Schiebel, I.~ and K{\"o}nig, F.~ and Leodolter, S.~ and Sliutz, G.~ and Koelbl, H.~},
  title = {Vascular Endothelial Growth Factor (VEGF) and Discrimination between Abnormal Intrauterine and Ectopic Pregnancy.},
  journal = {Human Reproduction},
  year = {2002},
  volume = {17},
  number = {12},
  pages = {3231--3234},
  issn = {0268-1161 0268-1161},
  doi = {10.1093/humrep/17.12.3231},
  keywords = {Adult;Female;Humans;Sensitivity and Specificity;Case-Control Studies;Prospective Studies;Pregnancy;Gestational Age;Diagnosis;Differential;Vascular Endothelial Growth Factor A;Vascular Endothelial Growth Factors;Endothelial Growth Factors/*blood;Intercellular Signaling Peptides and Proteins/*blood;Lymphokines/*blood;Pregnancy;Ectopic/*diagnosis}
}

@ARTICLE{angermayr2002ccsc378a378a,
  author = {Angermayr, B.~ and Koenig, F.~ and Cejna, M.~ and Karnel, F.~ and Gschwander, M.~ and Ferenci, P.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Creatinine-Modified Child-Pugh Score (CPSC) Compared with Meld-Score to Predict Survival in Patients Undergoing Tips.},
  journal = {Hepatology},
  year = {2002},
  volume = {36},
  number = {4, Pt 2: Abstracts 53rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Boston, MA, USA, 1–5 November 2002},
  pages = {378A},
  issn = {0270-9139},
  url = {https://www.ncbi.nlm.nih.gov/pubmed/12375592}
}

@ARTICLE{angermayr2002etuv511a511a,
  author = {Angermayr, B.~ and Cejna, M.~ and Karnel, F.~ and Gschwantler, M.~ and Koenig, F.~ and Poetzi, R.~ and Schoefl, R.~ and Lammer, J.~ and Gangl, A.~ and Peck-Radosavljevic, M.~},
  title = {Emergency Tips for Uncontrolled Variceal Bleeding: Risk-Factors and Prognosis of Patients in Vienna.},
  journal = {Hepatology},
  year = {2002},
  volume = {36},
  number = {4, Pt 2: Abstracts 53rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Boston, MA, USA, 1–5 November 2002},
  pages = {511A},
  issn = {0270-9139},
  url = {https://www.ncbi.nlm.nih.gov/pubmed/12375592}
}

@ARTICLE{fruehwald2002pcvs691696,
  author = {Fr{\"u}hwald, S.~ and Frottier, P.~ and Benda, N.~ and Eher, R.~ and K{\"o}nig, F.~ and Matschnig, T.~},
  title = {Psychosoziale Charakteristika von Suizidopfern in Gef{\"a}ngnissen.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2002},
  volume = {114},
  number = {15-16},
  pages = {691--696},
  note = {[Editorial]},
  issn = {0043-5325 0043-5325},
  url = {https://www.ncbi.nlm.nih.gov/pubmed/12602113},
  keywords = {Adult;Female;Humans;Male;Risk Factors;Austria/epidemiology;Comorbidity;Socioeconomic Factors;Social Adjustment;Prisoners/*psychology/statistics \& numerical data;Ethnic Groups/psychology/statistics \& numerical data;Mental Disorders/mortality/psychology;Suicide/ethnology/prevention \& control/*psychology/statistics \& numerical data}
}

@ARTICLE{frottier2002dlpa162167,
  author = {Frottier, P.~ and Matschnig, T.~ and Benda, N.~ and Eher, R.~ and K{\"o}nig, F.~ and Fr{\"u}hwald, S.~},
  title = {Die letzte psychiatrische Anstalt.},
  journal = {Recht \& Psychiatrie},
  year = {2002},
  volume = {20},
  number = {3},
  pages = {162--167},
  url = {https://psycnet.apa.org/record/2002-04771-001}
}

@ARTICLE{wagner2002qafa905912,
  author = {Wagner, A.~ and Schicho, K.~ and Birkfellner, W.~ and Figl, M.~ and Seemann, R.~ and K{\"o}nig, F.~ and Kainberger, F.~ and Ewers, R.~},
  title = {Quantitative Analysis of Factors Affecting Intraoperative Precision and Stability of Optoelectronic and Electromagnetic Tracking Systems.},
  journal = {Medical Physics},
  year = {2002},
  volume = {29},
  number = {5},
  pages = {905--912},
  issn = {0094-2405 0094-2405},
  doi = {10.1118/1.1469625},
  keywords = {Humans;Tomography;X-Ray Computed;Biophysical Phenomena;Biophysics;Models;Anatomic;Phantoms;Imaging;Electromagnetic Phenomena/instrumentation;Electronics;Medical/instrumentation;Optics and Photonics/instrumentation;Skull/anatomy \& histology/diagnostic imaging/surgery;Surgery;Computer-Assisted/*instrumentation/statistics \& numerical data}
}

@ARTICLE{kucera2001beaa12861290,
  author = {Kucera, E.~ and K{\"o}nig, F.~ and Tangl, S.~ and Grosschmidt, K.~ and Kainz, C.~ and Sliutz, G.~},
  title = {Bcl-2 Expression as a Novel Immunohistochemical Marker for Ruptured Tubal Ectopic Pregnancy.},
  journal = {Human Reproduction},
  year = {2001},
  volume = {16},
  number = {6},
  pages = {1286--1290},
  issn = {0268-1161 0268-1161},
  doi = {10.1093/humrep/16.6.1286},
  keywords = {Adult;Female;Humans;Logistic Models;Pregnancy;Biomarkers/*analysis;Immunohistochemistry;Gestational Age;Apoptosis;Cell Survival;Chorionic Villi/chemistry;Fallopian Tube Diseases/*diagnosis/*metabolism;Pregnancy;Tubal/*metabolism;Proto-Oncogene Proteins c-bcl-2/*analysis;Rupture;Spontaneous/diagnosis/metabolism;Trophoblasts/chemistry}
}

@ARTICLE{frottier2001dvie9096,
  author = {Frottier, P.~ and Fr{\"u}hwald, S.~ and Ritter, K.~ and K{\"o}nig, F.~},
  title = {Deprivation versus Importation: ein Erkl{\"a}rungsmodell f{\"u}r die Zunahme von Suiziden in Haftanstalten.},
  journal = {Fortschritte der Neurologie Psychiatrie},
  year = {2001},
  volume = {69},
  number = {02},
  pages = {90--96},
  issn = {0720-4299},
  doi = {10.1055/s-2001-11173}
}

@ARTICLE{frottier2000cbsr415s416s,
  author = {Frottier, P.~ and Ritter, K.~ and Fr{\"u}hwald, S.~ and K{\"o}nig, F.~ and Bauer, P.~},
  title = {Correlation between Suicide Risk, Time Spent in Prison and Vulnerability Profile of People in Confinement.},
  journal = {European Psychiatry},
  year = {2000},
  volume = {15},
  number = {Suppl 2: Abstracts Congress of the Association of European Psychiatrists, Prague, Czech Republic, 28 October–1 November 2000},
  pages = {415s--416s},
  issn = {0924-9338},
  doi = {10.1016/S0924-9338(00)94753-9},
  url = {http://www.sciencedirect.com/science/article/pii/S0924933800947539}
}

@ARTICLE{kucera2000iemm749753,
  author = {Kucera, E.~ and Tangl, S.~ and Klem, I.~ and K{\"o}nig, F.~ and Grossschmidt, K.~ and Kainz, C.~ and Sliutz, G.~},
  title = {Immunohistochemical Expression of Matrix Metalloproteinases 1 and 2 (MMP-1 and MMP-2) and Tissue Inhibitor of Metalloproteinase 2 (TIMP-2) in Ruptured and Non-Ruptured Tubal Ectopic Pregnancies.},
  journal = {Wiener Klinische Wochenschrift},
  year = {2000},
  volume = {112},
  number = {17},
  pages = {749--753},
  issn = {0043-5325 0043-5325},
  url = {https://www.ncbi.nlm.nih.gov/pubmed/11042903},
  keywords = {Adult;Female;Humans;Retrospective Studies;Data Interpretation;Statistical;Pregnancy;Immunohistochemistry;Coloring Agents;Image Processing;Computer-Assisted;Rupture;Spontaneous;Pregnancy;Tubal/*metabolism;Matrix Metalloproteinase 1/*metabolism;Matrix Metalloproteinase 2/*metabolism;Tissue Inhibitor of Metalloproteinase-2/*metabolism}
}