Recruitment, follow-up, and withdrawal
Patients who meet the eligibility criteria and have provided informed consent will be randomized and will undergo the planned evaluations at T0 (see Table A CONSORT flow diagram specifically designed for the Promotoer study (Fig. Promotoer CONSORT flow diagram (CONSORT 2010)The timing of withdrawals and loss to follow-up, whenever possible, will be presented as time-to-event data and analysed using Kaplan–Meier curves, stratified by intervention group. The Log-rank test will be employed to assess any potential differences between the two curves. Furthermore, the reasons for the loss of participants during the study will be described for each intervention group.The data collected from participants who have withdrawn from the study will be included in the analysis sets, unless the participants expressly withdraw their consent for the use of data collected until that time point.