1 Methodology Working Group, College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; Clinical Trial Methodology Department, Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands. Electronic address: K.OudeRengerink-2@umcutrecht.nl.
2 Methodology Working Group, College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; Clinical Trial Methodology Department, Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
3 Methodology Working Group, College ter Beoordeling van Geneesmiddelen, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; Department for Health Evidence, Section Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein 21, 6525 GA Nijmegen, the Netherlands.
4 Biostatistics and Methodology Support Office, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, the Netherlands.