Statistical Analysis
SECONDARY
In the primary analysis, the intention-to-treat population was considered, including all patients who were randomized and had provided at least baseline characteristics. Analyses followed a statistical analysis plan that was written before data collection was completed and analysis began (Primary and secondary outcomes were compared between the 2 groups using A post hoc subgroup analysis was assessed for the primary outcome as follows. RRs were considered with tests for the interactions between the study group and prior identified subgroups. Three subgroups were examined: women older than 30 years, tobacco users, and nulliparous women. Imputation models were implemented using the MICE and miceadds R packages (R studio version 3.6.0; The R Foundation), with statistical significance set at 2-sided 