Missing data
The primary analysis will be performed on all available cases. During the conduction of the trial, data collection will be monitored to minimize missing data for the primary outcome. Moreover, we have planned sensitivity analyses for addressing missing data [The following data will be obtained separately for each intervention group:Proportion of participants with missing data for the primary outcomeComparison of baseline characteristics between participants with available data and participants with missing data for the primary outcomeIf no important difference in baseline characteristics is observed between participants with available data and participants with missing data for the primary outcome, comparisons of intervention groups for the primary outcome will be carried out using multiple imputation techniques for missing data [In case of a relevant amount of missing data (more than 25% of dropouts), a revision of the SAP will be necessary.