1 Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, England;2 Statistical Consultant, Middletown, Ohio;3 Medpace, Warsaw, Poland;4 Division of Gastroenterology, University of Miami Leonard M. Miller School of Medicine, Miami, Florida;5 Centre for Statistics in Medicine, University of Oxford, Oxford, England;6 Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Lille, France;7 Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada;8 Section of Gastroenterology & Nutrition, University of Chicago Medical Center, Chicago, Illinois;9 Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;10 AP-HP, Hôpital Lariboisière Medicosurgical Department of Digestive Diseases and University Denis Diderot, Paris, France;11 Universitätsklinik Innere Medizin III, Abteilung Gastroenterologie und Hepatologie, Medical University of Vienna, Vienna, Austria;12 Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York;13 Division of Digestive Diseases, University of Cincinnati, Cincinnati, Ohio;14 Mathematics Department, Ohio State University, Columbus, Ohio;15 Bernhardt Regulatory Consulting, Cincinnati, Ohio;16 INSERM Unité 717 Biostatistics and Clinical Epidemiology, Université Paris Diderot, Paris, France;17 Division of Gastroenterology, University of California San Diego, La Jolla, California