Statistical Analysis
SECONDARY
Sample size estimation was performed using G*Power (version 3.1; Heinrich-Heine-Universität Düsseldorf) [An intention-to-treat approach was used in all data analyses that included all participants. Baseline data are shown as means and SDs for continuous variables and as counts and percentages for categorical variables, with differences in randomization groups assessed using independent sample 2-tailed For the primary and secondary outcomes, an analysis of a linear mixed model was used to compare the effects of the intervention between groups, accounting for both repeated measures and individual heterogeneity (random effect) [An additional post hoc subgroup analysis was performed using tests for intervention-subgroup interactions to explore whether the primary outcome results differed in subsets of participants grouped by baseline characteristics.Statistical analyses were performed using R software (version 4.2.1; R Foundation for Statistical Computing). A 2-sided 