Kinde‐Gazard 2012 BEN.

Methods	Trial design: RCT Follow‐up: Patients were hospitalized for the first three days, and monitored clinically and biochemically. Following discharge patients were seen on Day 7, 14, 21, and 28 with a malaria blood film at each visit. Adverse event monitoring: A symptom questionnaire, biochemistry (U and E, LFT), and haematology were conducted at each visit.
Participants	Number: 174 participants randomized Inclusion criteria: Age 6 months to 15 years, clinical signs of uncomplicated malaria, temp > 37.5°C or history of fever in the last 24 hours, asexual P. falciparum density > 2000/μL, able to take oral medication, informed consent. Exclusion criteria: Signs of severe malaria, known hypersensitivity to study medications, treatment with antimalarials within the past 7 days, positive pregnancy test. In addition the trial authors state that they planned to exclude the following groups from the study: severe toxicity, abnormal biochemical tests, unsatisfactory therapeutic response. However, no participants appear to have been excluded for these reasons.
Interventions	1. Artemesinin‐naphthoquine 125 mg/50 mg, fixed‐dose combination (Arco, Kunming Pharmaceutical Corporation, China): weight < 10 kg 1 tablet, single dose weight 10 to 15 kg 2 tablets, single dose weight 16 to 25 kg 4 tablets, single dose weight 26 to 35 kg 6 tablets, single dose weight > 35 kg 8 tablets, single dose 2. AL 20 mg/120 mg, fixed‐dose combination (Coartem, Novartis SA, Switzerland): weight < 15 kg 1 tablet, twice a day for 3 days weight 15 to 24 kg 2 tablets, twice a day for 3 days weight 25 to 35 kg 3 tablets, twice a day for 3 days weight > 35 kg 4 tablets, twice a day for 3 days
Outcomes	PCR‐adjusted and PCR‐unadjusted treatment failure at Day 28 Haemoglobin Adverse event Fever clearance Parasite clearance
Notes	Country: Benin Setting: Hospital Transmission: High Resistance: Chloroquine and SP Dates: July to Oct 2008 and May to Sept 2009 Funding: None stated, however the randomization procedure was done by the manufacturer of artemisinin‐naphthoquine
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"According to a randomization method".
Allocation concealment (selection bias)	Unclear risk	None described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Described as "single blind", however as the drug regimens differed significantly blinding of patients and personnel is unlikely.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding described.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up reported.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Other bias	Unclear risk	Funding is unclear, but the pharmaceutical company appear to be involved.