Statistical analysis
REGRESSION
Since this study is an exploratory study (i.e. is not a confirmatory study), the sample size was determined using precision-based method for the primary endpoint (change in E/e′ from the baseline to 48 weeks). If the sample size was set at 87 subjects per group, the difference in primary endpoint between the azilsartan and candesartan groups divided by the common standard deviation (i.e. standardized effect size) could be estimated with a sufficient precision which achieves the 0.6 width of the 95% confidence interval. Hence, the planned sample size was set at 95 subjects per group, with consideration for dropouts.Analyses were performed based on the intention-to-treat principle. For the primary endpoint, i.e. the change from baseline to 48 weeks in E/e′, the analysis of covariance was used to calculate an adjusted mean difference and its 95% CI, where baseline E/e′ was included as a covariate. For subgroup analyses, regression methods were used with appropriate interaction terms (respective subgroup × treatment group). Secondary endpoints were descriptively analyzed, and while categorical variables were assessed using the Pearson chi-square test or Fisher’s exact test, continuous variables were analyzed with the Student’s 