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Percent changes from baseline were analyzed with an ANCOVA model with treatment as a factor and baseline as the covariate.

Absolute HbA1c change from baseline was analyzed with a mixed effects model including a moderator for baseline HbA1c.

The percentage of patients with ≥15-letter BCVA improvement from baseline was analyzed with the Cochran-Mantel-Haenszel general association test stratified by study, with the 95%% confidence interval of the between-group difference constructed using normal approximation for binary variables.

Within-group changes from baseline were analyzed by ANOVA with Bonferroni post hoc tests adjusting for multiple comparisons.

Changes from baseline were analyzed using ANCOVA with region and treatment as factors, and baseline as covariate (using LOCF imputation of missing data).

Changes from baseline were analyzed using ANCOVA, with treatment and geographic region as class effects and baseline value as a continuous covariate.

The association between spontaneous BRS and 24-h AMBP and office blood pressure at baseline were analyzed in patients with AMBP data available.

The ER status (positive vs. negative), PgR status (positive vs. negative), Ki67 LI (high vs. low), and p27Kip1 expression (high vs. low) at baseline were analyzed for their relationships with pCR.

Following analysis by Kolmogorov-Smirnov test for normality of distribution, differences in comparison with baseline were analyzed by Student paired t test.

Subjects with significant depressive or manic/mixed symptoms at baseline were analyzed.

Changes from baseline were analyzed by ANOVA.