Population for Analysis Clause Samples

Population for Analysis. ‌ The following subject populations will be created: • Intent-to-Treat (ITT): All enrolled subjects. ITT analysis will be per randomized group irrespective of the treatment actually received. • Per Protocol (PP): All ITT subjects excluding those with major protocol violations. PP analysis will be per actual treatment group which is the same as the treatment initially randomized. • As the PP analysis is more conservative for non-inferiority hypothesis, all hypotheses will be tested with the PP population. ITT analysis will also be performed for all hypotheses, as the primary analysis for the primary endpoint, and the supportive analysis for secondary endpoints with non-inferiority hypothesis.