Full Analysis Set (FAS)
ICH
Compliance with the ITT principle would necessitate complete follow-up of all randomised subjects for study outcomes. As this cannot be achieved in most studies, a full analysis set (FAS) was planned to be analysed for providing evidence of an effect. This is as complete as possible and as close as possible to the ITT set (FAS) including all randomised test persons. The elimination of individuals was considered to be justified according to the ICH E9 guideline in the following cases:Violation of an essential and, before randomization, objectively measurable inclusion criterion.Not taking a single dose of the test substance (without knowledge of the assigned test group).Lack of any dates for the assessment of effectiveness after randomization.