Statistical Analyses
SECONDARY
Analyses were performed according to a prespecified statistical analysis plan. Descriptive analyses present distributions as frequency (%) for categorical variables and means with standard deviations (SDs) or medians with interquartile ranges (IQR), as appropriate, for continuous variables. Differences between the study arms and between the subgroups (age, gender, severity) were tested using either a two-sample t-test or the Wilcoxon rank-sum test for continuous variables and Pearson xThe pre-specified modified intention-to-treat (mITT) analysis population for the primary and secondary endpoints included all the patients who completed one month of study. The per-protocol (PP) analysis population included all participants from the mITT population who adhered adequately to the protocol. In the SOC arm, participants who purposefully or accidentally initiated more than one therapy session greater than or equal to 5 minutes in duration during the month were excluded from PP analysis. In the TX arm, participants who completed only one TAPS session or no TAPS sessions during the month were excluded from PP analysis. The rationale is that these TX patients would not have complied with the study protocol of using TAPS as needed beyond the training session. If a TX patient completed at least two TAPS sessions of at least 5 minutes duration during the month, they were included in the PP analysis.