Statistical analysis plan
REGRESSION, ADVERSE EVENT
Descriptive statistics will be used to summarize all baseline characteristics with the number of participants with data (all variables), mean, standard deviation, median, interquartile range, minimum and maximum (continuous variables), and frequencies and proportions (categorical variables).Analyses of the efficacy endpoints will be performed on an intention-to-treat-basis, and full analysis set (FAS) will be identified from all randomized participants by excluding participants who (1) withdrew their consent after enrollment, (2) those who are found to be not eligible after enrollment, (3) those have not received any protocol treatment after allocation, and (4) those without any efficacy data after the initiation of protocol treatment. In the FAS population, the participants without serious protocol deviations will be designated as per protocol set for the supplemental efficacy analysis. Regarding the primary endpoint, changes from baseline in CAVI to 24 weeks after protocol treatment will be analyzed using a linear regression model with the treatment group as a fixed effect and the baseline value as a covariate. Mean changes in both treatment groups with two-sided 95% confidence intervals (CIs) will be estimated based on the least squares mean at 24 weeks. Moreover, the group-difference with 95% CI and Safety analysis will be conducted on all randomized patients who have received at least one dose of the protocol treatment. The reported AEs should be assigned with a lower-level term code using the Japanese version of the MedDRA/J dictionary of regulatory terms. AEs occurring after the start of protocol treatment will be counted, and AEs that are considered to be causally “related” to finerenone will be considered as its side effects. If an adverse event of the same preferred term occurs more than once in a participant, the number of occurrences, and the number of participants will be counted separately. For all AEs and side effects, the number of occurrences, number of participants, and its percentage with 95% CI in each treatment group will be calculated.The principal investigator (KN) and a statistician (TI) will finalize the detailed statistical analysis plan before the database lock. All 