Baseline characteristics of subjects in the intention-to-treat and per-protocol populations.

Values are mean±SD; ITT: intention-to-treat; PP: per-protocol; F: female; M: male. The baseline data in the dietary supplement and placebo groups were compared using Student’s t-tests for quantitative variables and Fisher's exact test for sex. No statistically significant difference was found between the two treatment groups in either of the two study populations.