Sample size A non-parametric paired Wilcoxon test was performed to determine sample size, which was based on a significance level (α) of 0.05, 80% power (1 – β), and an estimated standardized effect size of 0.27. Using these parameters, a sample size of N = 125 eligible participants to retain 100 completed participants was obtained to be sufficient to observe improvement in QoL. The Full Analysis Set population and the modified intention-to-treat (mITT) population were considered the same in this instance as participants used the study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments.