Adherence and protocol deviations
Adherence to study interventions (BCI-MI or Control-MI) is fixed as a minimum of 9 training sessions (out of 12) delivered within 6 weeks. Moreover, protocol deviations include loss at follow-up (withdrawal/drop-out/death for any cause) and/or missed assessment for primary outcome at T1. The number of patients with adherence to the study intervention and the number of patients showing deviations from the planned study intervention will be reported for each intervention group. Deviations will be described for each patient by intervention group.Major protocol deviations are missing adherence to study interventions.