Authors’ contributions
CDi
All authors contributed to the study. NK, CDo, CDi, BP, CK, BL, SF, HvdW, JvB, and JV initiated the study design. JV and NK are grant holders, NK is the principal investigator, and JV is the project leader. CDo and CK provided methodological and statistical expertise in clinical trial design. CDi provided health technology assessment expertise. JV provided the first draft of this manuscript; RB assisted with writing the first draft. All authors contributed to the refinement of the study protocol and read and approved the final manuscript.