2.3. Statistical Analysis
ADVERSE EVENTS, SECONDARY
The analysis population of this clinical trial is divided into the intent-to-treat (ITT) analysis population, per-protocol (PP) analysis population, and safety analysis population. The efficacy evaluation was performed for both the ITT and PP analysis populations, but the final assessment for the primary efficacy evaluation variable was based on the PP analysis population. The ITT analysis population was also included for comparison, and individual participant results were provided if there were significant differences. The analysis of secondary efficacy evaluation variables was conducted using both the ITT and PP analysis populations, but the final assessment of the effect was based on the results of the ITT analysis population. The safety analysis population was defined as all participants who received the investigational drug at least once after randomization.Baseline observational values, including demographic data, were analyzed for this clinical trial. For continuous variables, mean, standard deviation, minimum value, maximum value, etc., were calculated. For categorical variables, absolute and relative frequencies, as well as corresponding percentages, were computed. To compare the trial group and control group regarding demographic variables, Student’s The primary endpoint aimed to demonstrate that the change in the Kupperman index from baseline to the final evaluation at 12 days after treatment in the Unicenta group was not inferior to the Melsmon group (control group). To confirm non-inferiority, a one-sided 97.5% confidence interval for the difference in the mean change in the Kupperman index between the Unicenta group and the Melsmon group was calculated. Specifically, if the lower bound of the one-sided 97.5% confidence interval for the difference in the mean change in the Kupperman index was greater than −3.2, it was determined that the Unicenta group was not inferior to the control group. For the secondary endpoints, the mean, standard deviation, and 95% confidence interval were provided separately for the trial group and control group. A Student’s The number and percentage of subjects experiencing one or more adverse events were reported for each group, considering the severity of adverse events, their relationship with the investigational drug, and the actions taken and their outcomes. The number and percentage of subjects were described separately for each investigational drug. To compare the incidence rates of adverse events between the two groups, a chi-square test was used. The normal range for clinical trial laboratory tests was based on the respective institution’s reference standards. For safety evaluation results, descriptive statistics (mean, standard deviation, median, minimum value, maximum value) were provided for continuous data. A Student’s For categorical data among laboratory tests, a chi-square test or Fisher’s exact test, was used to compare differences between groups. McNemar’s test was employed to analyze within-group categorical data before and after the application of the investigational drug. Descriptive statistics (mean, standard deviation, median, maximum value, minimum value, etc.) were provided for continuous variables among clinical examination results. The variables were categorized as below the normal range, within the normal range, or above the normal range based on each institution’s normal range criteria. Categorical variables were classified as normal or abnormal.