Statistical Analysis
SECONDARY
Linear mixed-effects models were fitted to primary and secondary outcome variables with time and time-by-treatment interaction as categorical fixed effects. The main effect of treatment was removed from the model to adjust for potential baseline differences in the outcome. The models included a random intercept and a random effect for time. Three variables (PART-O social subscale score, QOLIBRI overall scale score, and GAD-7 score) could not be modeled with the random effect for time; thus, only a random intercept was used. Based on the linear mixed-effects models, mean values for primary outcomes were estimated with 97.5% CIs for all time points (baseline, 4 months, and 12 months) for each group. We also estimated mean within-group and between-group differences in change from baseline to 4 months and from baseline to 12 months. Analyses were performed using the intention-to-treat approach. To accommodate for having 2 independent primary outcomes, a conservative significance level of 2-tailed 