PPS group

The PPS group included subjects who completed this study according to the clinical trial protocol among subjects included in the FAS group.

In this case, only the following among randomized subjects were excluded from statistical analysis during PPS analysis.

- Those who violate the test plan.

- Those who take contraindicated medications, those with a continuous compliance of 80% or less, and those who do not comply with the visit period.

In principle, the main analysis of the efficacy data obtained from this study was performed in the FAS analysis group, and the PPS analysis group was additionally performed. Analysis of data on safety was performed in the safety analysis group. For demographic and health status, the characteristics of the data were evaluated utilizing the mean, standard deviation, maximum value, and minimum value through basic statistical analysis. In the case of continuous data, the average value of the test group and the control group were compared through ANOVA analysis. Categorical data were analyzed using the Chi-square test or Fisher’s exact test.