Burri 2000.

Methods	Randomized controlled equivalence trial Generation of allocation sequence: randomization in blocks of 10 Allocation concealment: opaque sealed envelopes Blinding: not feasible Inclusion of all randomized participants: ITT profile included, 88.4 % participants completed treatment Duration: not mentioned
Participants	Number randomized: 500 Inclusion criteria: age > 14 years; confirmed second‐stage T. b. gambiense infection; trypanosomes in CSF or > 5 WBC/μL in CSF. Exclusion criteria: Glasgow coma score < 8; pregnancy; active tuberculosis Diagnosis and follow‐up methods: cerebrospinal fluid (CSF) examination, double centrifugation
Interventions	1. Melarsoprol: 1.2 mg/kg on day 1, 2.4 mg/kg on day 2, 3.6 mg/kg on day 3, and 3.6 mg/kg on day 4; 3 series repeated at 7‐day intervals; administered intravenously 2. Melarsoprol: 2.2 mg/kg/day per 10 days; administered intravenously All participants were pretreated with chloroquine, mebendazole, multivitamins, and paracetamol Prednisolone was given to all participants at 1 mg/kg followed by decreasing doses
Outcomes	1. Cure rates at 24 h after treatment 2. Death 3. Relapse 4. Adverse events
Notes	Location: Kwanza Norte Province, Angola Setting: Trypanosomiasis Units Funding: Swiss Agency for Development and Cooperation, partly World Health Organization: Division of Control of Tropical Diseases.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation in blocks of ten was done during pretreatment
Allocation concealment (selection bias)	Low risk	Non transparent, sealed envelopes were used
Blinding (performance bias and detection bias) All outcomes	High risk	Stated: "A masked trial design was not possible" because of substantial differences between the two treatment schedules
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis included; 88.4% participants analysed (not adequate)