Statistical Analysis
We included all randomized participants in our intention-to-treat analysis. For all outcomes, we report mean within-group changes (from baseline to 6 months) and between-group comparisons of changes (ie, difference) with corresponding 95% CIs. We used linear mixed-effects modeling with a random intercept for each patient to examine the association between study group and outcomes. We chose this model to account for both within-patient correlation and missing data (eg, due to loss to follow-up). Models included an interaction term of time × study group to test for the significance of between-group (difference) comparisons. To quantify the magnitude of influence of outliers on the difference between groups, we conducted sensitivity analyses of outliers by excluding those with large model-based residuals and comparing results from a model with and without outliers. Testing for all analyses was 2 sided at a significance level of 