2.3. Statistical analysis
erosion, erosion of CKD-495
ACUTE AND CHRONIC GASTRITIS, EROSION
This study aimed to demonstrate that the endoscopic improvement rate of CKD-495 75 mg, at Week 2 is superior to that of the AAF 60 mg, in patients with acute and chronic gastritis. To calculate the sample size, the improvement rate of erosion of CKD-495 and AAF was assumed based on the result of the Phase II study of CKD-495. When the improvement rate of CKD-495 75 mg and AAF 60 mg was set to 73.08% and 52.08%, respectively, the sample size calculated with a 2-sided 5% significance level (α), power (1- β) of 90%, dropout rate of 10%, and allocation ratio of 1:1 was 119 subjects per group, totally 238 subjects.The analysis group was divided into 3 groups: full analysis set (FAS), per protocol analysis set (PPS) and safety set. The FAS included all randomized patients who received at least one dose of the study drug and underwent at least one efficacy measurement after treatment with the study drug. The PPS included all randomized patients except those who had major protocol violations or had poor drug compliance (<80% or >120%) and terminated the clinical trial ahead of schedule. The safety set included all patients who took the study drugs at least once. All efficacy endpoints were analyzed in the FAS and PPS.In the analysis of baseline characteristics, continuous variables were presented as mean and standard deviation and were analyzed by the 2-sample t-test or Wilcoxon rank-sum test for between-group comparisons. Categorical variables were presented as number and proportion and were analyzed using chi-square or Fisher exact test for between-group comparisons. Endoscopic improvement rates of erosion were analyzed by the Wald test including study site as a covariate, and results are presented as odds ratio (OR), 95% confidence interval (95% CI) and 