2.7. Sample Size Calculation
Based on the results of the previous clinical trial (Clinical Trial Registry no. UMIN 000041724), a total of 66 participants was calculated to be necessary to detect a difference of 1.27, with 1.7 standard deviations in the Euthymia Scale between the REP hydrolysate group and the placebo group with a two-sided significance level of 5% and 85% power. The final sample size was determined to be 76 with a predicted dropout rate of 15%.