Analysis population
The intention-to-treat population will include all randomized patients, regardless of their eligibility, according to the treatment they were randomized to receive.The per-protocol analysis set will consist of subjects who (1) were randomly assigned to treatment, (2) have no major protocol violations, (3) comply with the eligibility criteria, (4) have both a baseline and 6-month measurement on the given outcome with the variation in the timing of the 6-month measurement not greater than one month, (5) adhered to the intervention (see the “