Statistical analysis
SECONDARY
Statistical analyses were performed with a full analysis set (FAS) and safety analysis set (SAS). FAS was defined as all subjects without violations of the main eligibility criteria (selection and exclusion criteria) or conflicts with discontinuation and dropout criteria. SAS was defined as all subjects who received the study treatment. An efficacy analysis was performed with FAS. The safety analysis was conducted with SAS.In the primary efficacy analysis, non-inferiority was examined using the Farrington-Manning test for efficacy differences from a non-inferiority margin of 20%. Differences in secondary outcomes were evaluated using χ