Pepin 1989a.

Methods	Prospective randomized trial Generation of allocation sequence: not described Allocation concealment: not specified Blinding: not done Inclusion of all randomized participants: ITT or per protocol profile not included, but 598 participants out of 620 enrolled, completed treatment (96.4%) Study conducted between March 1984 and October 1988
Participants	Number randomized: 620 Inclusion criteria: parasitologically confirmed cases of T. b. gambiense Diagnosis and follow up methods: standard parasitological investigations and white cell count (WCC)
Interventions	1. Melarsoprol: 3.6 mg/kg; 2 series of 3 injections if WCC < 20, 3 series of 3 injections if WCC = 20 to 99, or 3 series of 4 injections if WCC ≥100; 1‐week interval between first and second series, and 2‐week interval between second and third series 2. Melarsoprol + prednisolone: melarsoprol same as group 1; oral prednisolone as a single daily dose of 1 mg/kg up to a maximum of 40 mg started on the day before first dose of melarsoprol; given throughout first series, first interval, and second series of melarsoprol; discontinued over 3 days after second series, resumed on the day before third series, and discontinued over 3 days after the end of the third series Pretreatment: mebendazole, chloroquine, and suramin 24 h before first melarsoprol dose
Outcomes	1. Relapse 2. Death 3. Encephalopathy and other adverse events
Notes	Location: Nioki, Zaire (Democratic Republic of Congo) Setting: hospital Source of funding: Canadian International Development Agency
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomization was not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	High risk	Not done
Incomplete outcome data (attrition bias) All outcomes	Low risk	96.4% participants completed treatment