Statistical analyses
HGP1705
For estimating the necessary number of subjects, the complete healing rate of EE by week 8 was assumed to be 93.7% in the HGP1705 40 mg group [Safety analysis was conducted among those who took at least one dose of the clinical trial drugs after random assignment, for whom data on safety assessments could be obtained. All patients who received at least one dose of investigational drugs and underwent efficacy assessments at least once until the end of the clinical trial were included in the full analysis set (FAS). Among the patients included in the FAS, those who completed the clinical trial in accordance with the protocol were included in the PPS. Patients with major protocol violations or poor compliance (taking less than 70% of the total medications) were excluded from the PPS. Compliance was assessed by counting the unused medications at the completion of 4 or 8 weeks of treatment. For the primary efficacy evaluation, in principle, the PPS was the main analysis set, and the FAS was the supportive analysis set. Secondary efficacy analysis was performed using both PPS and FAS.The chi-square test or Fisher’s exact test was used to test for associations among various categorical variables, and the independent samples t-test or Wilcoxon’s rank-sum test was used for non-categorical variables. Comparisons between the two groups at weeks 4 or 8 were performed using the Cochran–Mantel–Haenszel test to analyze stratified categorical data (LA Classification, grades A/B and C/D). Statistical analyses were performed using SAS® Version 9.4, SAS Institute, Cary, NC, USA), and a 