Data analysis sets
| Randomised set | All 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 set | Patients of the full analysis set without relevant deviation, which could affect the evaluation of efficacy outcome. |
| Safety set | All patients having received at least one dose of the treatment. |