Statistical analyses
ADVERSE EVENTS
Analyses were performed using Stata (version 16; StataCorp, College Station, TX, USA) and intention-to-treat with all available data from all randomized participants using their randomized group allocation. Descriptive statistics were used to summarize the program adherence, the adverse events, and the randomization of characteristics in groups at baseline. Changes in exploratory outcomes were analyzed to provide an indication of the direction and magnitude of changes in symptoms and physical performance/activity and whether there may be some indication of MRI structural change. Continuous outcomes at baseline and 24 weeks are shown as means and standard errors derived from unadjusted linear mixed-effects models. The change between these time points by group is presented as means and 95% CI. To investigate whether there was a difference in slope between both groups, the difference of differences was analyzed by linear mixed-effects models for treatment, time point, and a treatment/time point interaction, adjusted for sex and age as covariates. The models were adjusted for the baseline value of the corresponding outcome, which is considered best practice in RCT analysis [