Timeframe of analyses and investigations
Investigations of this trial will take place at the baseline visit, followed by a 1-month, 2-month, 6-month, and 12/24/36-month visits. A margin of 2 weeks + / − of each visit will be allowed. Further visits might be needed to achieve the desired rate. A more detailed description of the timeframe of investigations can be found in Table 2 of the protocol [The primary analyses of all outcomes of this trial will be performed after all participants have completed a 12-month follow-up (after randomization). The 12-month follow-up will be regarded as our primary analysis timepoint, and the 24-month and 36-month analyses will be considered hypothesis-generating only to limit multiplicity.Furthermore, an independent data safety monitoring committee (IDSMC) will conduct an interim analysis after 33% of the sample size population has completed 12-month follow-up, to monitor whether the trial still holds scientific merit. The IDSMC will then decide if a new interim analysis should be performed.A more detailed description of the IDSMC and its interim analyses can be found in the protocol and the supplemental file 6 of the protocol [