Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
EVENTS
In the primary analyses, participants will be assessed according to the initially prescribed treatment, irrespective of intercurrent events, including whether and how treatments are received, non-adherence, changes to therapy, or loss to follow-up, i.e., the analysis will determine the effect attributable to the initial treatment plan, reflecting the de facto or “treatment policy” estimand.