Statistical analysis
EVENTS, SECONDARY
Analyses of the primary and secondary endpoints were performed using data from the full analysis set (FAS) population, including all subjects enrolled in this extension study, and excluding those violating the protocol severely (without written consent, enrollment outside the contract period, etc.). In principle, missing values were not complemented.Primary analysis was performed using the mixed-effects model for repeated measures (MMRM) with the treatment group, time (week), and interactions between the treatment group and time (week) as fixed effects, and subjects nested by group as random effects. An unstructured covariate was used to model the covariance of within-subject variability. The Kenward-Roger method was used to estimate the degrees of freedom. The sensitivity analysis assessed differences in changes in IMT-CCA from baseline between the two groups using analysis of covariance (ANCOVA) models that included the treatment group, age, sex, baseline IMT-CCA, systolic blood pressure, and administration of statins. For the occurrence of cardiovascular events as a secondary outcome, the time to onset was analyzed using the log-rank test and Cox proportional hazard model.Baseline and follow-up group comparisons were performed using Student’s t-test or Wilcoxon rank-sum test for continuous variables and Fisher’s exact test or chi-square test for categorical variables. Changes from baseline to treatment visits were assessed using a paired t-test and Wilcoxon signed-rank test within the group. The frequency and proportion of patients reporting AEs were derived from each treatment group and compared using Fisher’s exact test.All p values were two-sided. Statistical significance was set at p < 0.05. All analyses were performed using SAS version 9.4 (SAS Institute, Inc., Cary, NC, USA). All statistical analyses were performed by a third-party entity (Soiken Inc.) under the supervision of an independent biostatistician. The corresponding author had full access to all data in the study and had final responsibility for the decision to submit for publication.