Karema 2006 RWA.

Methods	Trial design: A 3‐arm open label RCT Follow‐up: History, clinical signs and symptoms, and malaria film on days 0, 1, 2, 3, 7, 14, 21, and 28 and any other day they felt unwell. PCV measured at days 0 and 14. Adverse event monitoring: An adverse event defined as any unfavourable and unintended sign associated temporally with the use of the drug administered. Differential WBC count (and liver function tests at 1 site only) assessed at days 0 and 14.
Participants	Number of participants: 762 Inclusion criteria: Age 12 to 59 months, weight > 10 kg, axillary temp > 37.5 °C or history of fever in the preceding 24 hrs, P. falciparum mono‐infection 2000 to 200,000/µL. Exclusion criteria: Severe malaria, any other concomitant illness or underlying disease, known allergy to trial drugs, clear history of adequate antimalarial treatment in the previous 72 hrs, PCV < 15%.
Interventions	1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleypharm) Total dose: DHA 4.8 to 9.3 mg/kg + P 38.4 to 73.8 mg/kg in 3 divided doses, given once daily for 3 days 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi) AS 4 mg/kg once daily for 3 days AQ 10 mg/kg once daily for 3 days All doses supervised
Outcomes	ACPR at day 28, PCR‐adjusted and PCR‐unadjusted Gametocyte prevalence during follow‐up Mean PCV at baseline and day 14 Adverse events Not included in this review: Fever clearance Parasite clearance
Notes	Country: Rwanda Setting: Peri‐urban and rural health centres Transmission: Not reported Resistance: Not reported Dates: Oct 2003 to Apr 2004 Funding: Belgian Development Co‐operation in collaboration with the Prince Leopold Institute of Tropical Medicine. DHA‐P provided by Holleypharm
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomly allocated in blocks of 15", computer generated sequence (information from author).
Allocation concealment (selection bias)	Unclear risk	"Allocation of treatment was concealed until final recruitment'. No further details.
Blinding for microscopy outcomes (performance bias and detection bias)	Low risk	"Laboratory technicians reading malaria slides did not know the treatment received".
Blinding for adverse events (performance and detection bias)	High risk	An open‐label trial.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Very low losses to follow‐up in all groups (0.8% DHA‐P versus 0.4% AS+AQ).
Selective reporting (reporting bias)	Low risk	All WHO outcomes reported. Day 28 outcomes may underestimate failure with DHA‐P due to its long half‐life.
Other bias	Low risk	No other sources of bias identified.