Statistical analyses
Given its pilot nature, the study was not powered to detect a significant between-group effect. Instead, precision analysis was performed to determine the sample size required to achieve a suitable confidence interval width for treatment effect estimation. Average soreness or discomfort was designated as the primary effect of interest. Assuming a pooled standard deviation of 1.62 based on previous studies for average soreness/discomfort post-DOMS [Efficacy analyses were based on the modified intention-to-treat (mITT) population. The mITT was defined as all participants who were randomized to formulation group and received at least one dose of their assigned formulation and had baseline and at least one post-baseline efficacy evaluation. To estimate treatment effects, outcomes were analyzed using mixed models for repeated measures that assumed a first-order autoregressive covariance and homogeneous variance structure. Fixed effects consisted of baseline values of each outcome, treatment group, day, and the interaction of treatment group and day. Treatment effect estimates were calculated as contrasts between active and placebo groups adjusting for baseline outcome measures within each post-DOMS assessment.To facilitate interpretation, standardized mean difference treatment effect measures were also calculated for all outcomes by dividing the raw treatment effect estimates derived from the analysis models described above by the average within-group standard deviation during the post-DOMS period [Following the recommendations of Lee et al. [Safety analyses were conducted in the safety population, which was defined as all participants who were randomized to treatment and received study formulation. Safety analyses consisted of tabulation of incidence of AEs and SAEs reported by participants.