Statistical analysis
RBD
SECONDARY
Statistical analysis (using SAS 9.4, Cary, NC) was by intention-to-treat for the primary efficacy analysis, comparison of baseline characteristics, safety and tolerance, and per-protocol (PP) for secondary/exploratory analyses. PP analysis included all participants who completed titration and the 4-week treatment period. Sample size calculation was based on a prior randomized controlled study by Brunetti et al [We tested the primary hypothesis that SXB is superior to placebo in reducing the number of RBD episodes from baseline, as observed in the last month of treatment using linear mixed-effects models with random intercepts. Models were parameterized in two ways to estimate separate group trajectories and between-group differences in change over time. Cohen’s d was calculated as a measure of treatment effect size. Similar hypotheses were tested on secondary and exploratory outcomes. Within- and between-group differences were assessed with paired- and unpaired 