3.2. Primary Endpoint
The primary endpoint evaluation of this trial used the change in Kupperman index scores from baseline to the final evaluation at 12 days as the outcome variable. To demonstrate non-inferiority between the study group and the control group, the lower limit of the two-sided 95% confidence interval for the difference between groups was calculated. The results of the primary endpoint evaluation for the per-protocol (PP) analysis population, i.e., the main analysis population for efficacy evaluation, are shown in 