Table 2 Analysis sets

Safety analysis population

All patients enrolled in the study who received at least one dose of the study medication

Intention-to-treat (ITT) population (full analysis)

All patients enrolled in the study who received at least one dose of study medication AND died during treatment or were non-responders OR reached a protocol-defined endpoint [probable relapse, relapse or death during follow-up (all causes of deaths)] OR for whom efficacy evaluation data at the test-of-cure visit (18 months) or a protocol defined earlier time-point are available

Per-protocol (PP) population

All patients enrolled in the study who: received at least one dose of study medication AND died during treatment or were non-responders OR for whom treatment was discontinued because of treatment-related adverse events OR completed the protocol-defined treatment (≥ 95%) AND reached one of the protocol-defined endpoints [probable relapse, relapse or death during follow-up (all causes of deaths except death clearly unrelated to HAT and treatment)] before the test-of-cure visit (18 months) OR have a test-of-cure visit assessment (at 18 months).

Modified full analysis (mITT) population

All patients enrolled in the study who received at least one dose of study medication AND died during treatment or were non-responders OR for whom treatment was discontinued because of treatment-related adverse events OR received a defined minimum amount of treatment (≥ 85%) AND reached a protocol-defined endpoint [probable relapse, relapse or death during follow-up (all causes of deaths)] OR for whom efficacy evaluation data at the test-of-cure visit (18 months) or a protocol defined earlier time-point are available