Supplementation
SOLUGEL
ADVERSE EFFECTS
Participants received a 1-month supply of their respective treatments supplement packages (placebo = maltodextrin, 10 g CP, or 20 g CP) at each monthly visit along with a compliance log to track days and times of supplementation. Treatments were packaged and supplied in opaque packets by the Sponsor to maintain a double-blind design. Participants were instructed to take the CP supplement twice daily (morning and evening) to achieve their total daily dose. The empty supplement packets and compliance log were brought back to the ISSM at each subsequent visit to determine if ≥ 80% adherence to supplementation was maintained. Participant compliance of ≥ 80% was to be maintained to remain in the study, and thus was verified at each monthly visit by study staff using a two-person quality control process (no participants were disqualified for noncompliance). No adverse effects were self-reported by participants in any of the treatment groups during study participation. Therefore, the CP supplements at both doses were found to be safe and well tolerated. The CP product (SOLUGEL ®) was third party tested to ensure good manufacturing practices.