Data management and statistical analysis
To generate an analysis dataset, the information on each patient obtained from the app, and from the electronic medical record routinely used in the CIDEIM, were collated into a CRF.The statistical analysis followed the methods pre-defined in the protocol and in the statistical analysis plan, and was by intention to treat. For each endpoint, the comparison of main interest was between the two randomized arms. However, the same methods were used for the non-randomized control group. The primary endpoint, the proportion of participants monitored at target study week 26, was compared between the arms using a χ