Adherence to study procedures
CRF
CRF
Due to stringent exclusion criteria and the long duration of the intervention period, we expect many participants to not be able to fully adhere to study procedures as outlined in the study protocol due to for example requiring antibiotic treatment or an unscheduled pregnancy. The study was planned and submitted prior to the COVID-19 pandemic outbreak, and therefore in many cases appointments and schedules for trial procedures may need to be altered. In such a case, deviations from the study protocol are documented in the CRF and participants may still continue with trial participantion. For the purposes of statistical analysis, all participants will be considered for the intention-to-treat analyses. The same statistical analyses will be applied additionally for the subpopulation that completely adhered to the trial protocol.