Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SECONDARY
The primary analysis will be performed using the ITT population, consisting of all participants who are enrolled, included within the study arm corresponding to the treatment assigned to the site during that study period. The ITT population will also be the population used in all secondary outcome, safety, and subgroup analyses. A per-protocol analysis will be conducted to gain additional insight, but the results will not replace the results of the ITT analysis. The per-protocol analysis dataset will consist of the subset of the ITT population who are confirmed eligible and are classified as protocol “adherent.”Per the ITT principle, subjects who withdraw from the study or are lost to follow-up will have all available data used in the analysis. Subjects who are missing data for a particular outcome will not be included in analysis of that outcome. If a substantial number of subjects are withdrawn or lost to follow-up, baseline characteristics and available information on hospital course will be reviewed and compared to subjects not withdrawn or lost, to assess empirically if these subjects differ from those remaining in the study for the scheduled treatment and follow-up time. However, we expect very little missing data for the primary outcome.