Arinaitwe 2009 UGA.

Methods	Trial design: An open label RCT Follow‐up: Blood smears taken on days 0, 2, 3, 7, 14, 21, and 28 after each episode and any time they felt ill. Follow‐up continued for up to one year. Adverse event monitoring: Clinicians assessed participants for adverse events using standardized criteria at each follow‐up visit. Passive monitoring was carried out for up to 63 days after treatment. Adverse events were defined as any untoward medical occurrence, regardless of its suspected relationship to the trial drugs, as per International Conference of Harmonization guidelines. Adverse events were graded as mild, moderate, severe, or life threatening.
Participants	Number of participants: 232, with 671 episodes of uncomplicated falciparum malaria treated. All episodes treated were included in the analysis. Inclusion criteria: For enrolment in the trial cohort: age 6 weeks to 12 months, HIV status of mother and child documented, living within a 30 km radius of the trial clinic, currently breast‐feeding if HIV exposed, and informed consent including consent to come to the trial clinic for any illness and avoid medications given outside of the trial. For randomization: uncomplicated malaria diagnosed by positive blood smear after documented fever of ≥ 38.0 °C or history of fever in the past 24 hrs, age ≥ 4 months, weight ≥ 5 kg. Exclusion criteria: Active medical problems requiring inpatient evaluation. For withdrawal from trial cohort: movement outside trial area, inability to tolerate trial drugs, withdrawal of informed consent, inability to be located for > 60 days, or inability to adhere to trial procedures and schedule.
Interventions	1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Duocotecxin: Holley Pharm) Target daily dose 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg piperaquine given in three equally divided daily doses to the nearest quarter tablet. 2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg (Coartem: Novartis) 5 to 14 kg 1 tablet twice daily for 3 days 15 to 24 kg 2 tablets twice daily for 3 days Only the first daily dose supervised. Subsequent episodes of malaria occurring > 14 days after a previous episode were treated with the assigned trial drug.
Outcomes	Recurrent falciparum parasitaemia at day 28, 42, 63, PCR‐unadjusted and PCR‐adjusted Gametocyte carriage Mean change in Hb from baseline to day 28 Adverse events Not included in this review: Incidence of malaria after randomization Fever clearance Parasite clearance
Notes	Country: Uganda Setting: Enrolled from local antenatal clinics in Tororo Transmission: High transmission Resistance: Not reported Dates: Aug 2007 to Jul 2008 Funding: Doris Duke Charitable Foundation and Puget Sound Partners in Global Health. Holleypharm provided DHA‐P free of charge.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A randomization list was computer generated by an off‐site investigator".
Allocation concealment (selection bias)	Low risk	"Sequentially numbered, sealed envelopes containing the treatment group assignments were prepared from the randomization list. The study nurse assigned treatment numbers sequentially and allocated treatment by opening the envelope corresponding to the treatment number".
Blinding for microscopy outcomes (performance bias and detection bias)	Low risk	No blinding of microscopists reported, but all slides were re‐read by a second microscopist, and a third microscopist resolved discrepancies.
Blinding for adverse events (performance and detection bias)	High risk	Described as "open‐label".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Similar low drop out in both groups (1.7% DHA‐P versus 1.6% AL6).
Selective reporting (reporting bias)	Low risk	All listed outcomes reported.
Other bias	Low risk	This trial randomized individuals to an ACT and then followed them up through multiple treatment episodes. The data presented is for the all malaria episodes reported during the trial period.