Statistical Analyses
Data normality was verified using the Shapiro-Wilk test. Measures of central tendency and dispersion were used as appropriate to describe sample characteristics. Between groups comparisons at baseline were performed with both independent t-test and Mann-Whitney U test for continuous variables, and Pearson’s Chi-Squared test or Fisher’s Exact test for categorical variables. Longitudinal changes in the outcome measures from baseline to 6-months were analyzed using linear mixed-effects models, considering group, time, and interaction time*group as fixed effects and participant as random effect. Adjustments were performed for age and sex. The least square mean within-group difference was estimated from these models. A significance level of 