Statistical analysis
REGRESSION
No power calculations were used to derive a sample size given this study sought to identify which health outcomes should be used for a larger randomized controlled trial in the future. The desired target sample size for this feasibility study was set at 10 analyzable data sets for each group. Enrollment of up to 30 participants was planned to achieve 60-day follow-up data on at least 20 participants.The analysis population includes all enrolled participants. Participants were assessed by treatment group for the primary endpoint. Ad hoc regression analyses were performed on the pooled cohort by compliance status (complete, partial, noncompliance), irrespective of the treatment assignment.Descriptive statistics were calculated for all continuous variables. Frequencies, percentages, and confidence intervals were calculated for categorical data. Any data found to be randomly missing within the survey measures were handled as specified by the survey developers. Nonrandom missing visit data were not imputed.Mixed effects regression models were fit to the data to account for the repeated (non-independent) nature of the measurements for each participant over multiple timepoints. An autocorrelation structure (AR1) was used to account for single-order correlation between timepoints. For each participant, the measures post baseline are likely dependent upon the prior timepoint. The post baseline means and differences presented in the tables are model estimated means and differences, and not the raw observed means and differences for each time point. A Tukey method was used to adjust the confidence intervals and Analyses were performed using R version 4.1.0 or higher (The R Foundation for Statistical Computing. 