Confidence intervals and P values
SECONDARY
The primary hypothesis testing will be performed at a one-sided alpha of 0.05. The significance level used for the primary outcome is consistent with that used in the sample size calculation. Hypothesis testing on any of the secondary outcomes will be performed at a two-sided alpha of 0.05. Treatment effects will be reported through mean differences for continuous variables and odds ratio for binary variables, with two-sided 95% confidence intervals.Adjustment for multiplicity will be considered in post-hoc comparisons of secondary analyses, specifically in comparisons among groups in each evaluation time (T1, T2, T3, and T4). Bonferroni’s correction criteria will be applied, and exact 