Statistical Analysis
SECONDARY
The analysis of covariance will be performed on the primary endpoint with last observation carried forward for missing values, as well as on the secondary efficacy parameters. All statistical tests between treatment groups will be tested at the 2-sided <0.05 significance level. Descriptive statistics will be performed on the safety outcomes. Two analysis sets will be used for the statistical testing: the full analysis set, including all randomized patients with baseline and at least one post-baseline data, and the per-protocol analysis set, including all randomized patients completing the study without major protocol deviations.