Table 4

Data analysis sets

Randomised setAll randomised patients
Full analysis set (based on intention to treat (ITT) principle)Randomised patients having the studied disease, having taken at least one dose of study treatment after inclusion and with at least one evaluation of the primary criteria.
Per-protocol setPatients of the full analysis set without relevant deviation, which could affect the evaluation of efficacy outcome.
Safety setAll patients having received at least one dose of the treatment.