Institutional Review Board Statement
Written informed consent was obtained from all participants prior to study enrollment. The PROMISS trial was registered at ClinicalTrials.gov (NCT03712306) and was approved by both the Institutional Review Boards of the Amsterdam UMC, location VUMC in Amsterdam, the Netherlands (approval code: 2018.399), and by the University of Helsinki (approval code: HUS/1530/2018). It was conducted in accordance with the Declaration of Helsinki (version 2013).