Safety analysis
EVENTS
For the safety co-primary objective, AEs will be analyzed in total and by body system. Tables will show the number of AEs observed and the number and percentage of participants experiencing them within a system organ class or within preferred term category by severity or by relationship to the study product. Participants with multiple AEs within a category will be counted once under the maximum severity or the strongest recorded causal relationship to the study product. Differences between AE rates in the intervention groups will be assessed by means of generalized estimating equations to account for the cluster design.A listing of SAEs reported to the DSMB will provide details of the events including severity, relationship to the study product, time between onset and last treatment, and the number of treatments administered and received by the study participant.The number and percentage of study participants who discontinue treatment and who terminate from the study early will be tabulated by reason and treatment arm.