Composition of the coordinating center and trial steering committee {5d}
The data will be monitored by the principal investigators, and access to the database is also handled by the principal investigator in collaboration with a data manager located in the Research Unit for Clinical Epidemiology, University of Southern Denmark, Odense, Denmark. The entire research group has access to the raw data. The research group will meet at least quarterly during the 1–2-year inclusion period and meetings will also be arranged on an ad hoc basis during the study period. The trial protocol has been registered at Clinical Trials (ClinicalTrials.gov — identifier: NCT04816812) after ethics approval was obtained.