Sutanto 2013

Methods	2-arm open-label RCT Follow-up: days 1, 2, 3, 7, 14, 21, 28, 35 and 42, and any other day in between if they felt ill. Thin and thick blood smears and dried blood spot for genotyping Dates of randomization: December 2008 to March 2010
Participants	188 (178 left on day 3) + 186 (171 day 3). Analysis based on those still present on day 3 Setting: Hanura Primary Health Center, Padang Cermin district, Lampung province located at the southern end of Sumatra. Endemicity: low malaria endemicity with a malaria prevalence of 1.8% across all age groups. Seasonal transmission. Inclusion criteria: (1) parasite density ≥ 1000 parasites/μL; (2) age ≥ 5 years; (3) normal glucose-6-phosphate dehydrogenase (G6PD) enzyme levels based on a qualitative test; (4) haemoglobin level ≥ 8 g/dL; (5) negative pregnancy test (assessed by human chorionic gonadotropin urine test) or not breastfeeding; (6) no signs of severe malnutrition; (7) no other chronic diseases; (8) no history of allergy to the trial drugs; (9) ability to return for 42 days of follow-up.
Interventions	1. Standard 3-day DHAP (fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine; D-ARTEPP, Guilin Pharmaceutical Co, Ltd) 2. DHAP as in intervention 1; PQ: Day 3, single dose of 0.75 mg/kg, rounded to the nearest half tablet. Mean dose was 0.74 mg/kg (range, 0.5 to 0.94 mg/kg)
Outcomes	1. Gametocyte prevalence-days 7, 14, 21, 28, 35, and 42 2. Gametocyte clearance rates by day 42 in patients with gametocytes on day 3, 3. Recurrence of asexual stages of P. falciparum, polymerase chain reaction (PCR) adjusted and unadjusted for reinfections. 4. Gametocyte development by day 42 in patients who were gametocyte free on day 3. 5. Gametocyte densities between days 3 and 42 inclusive. 6. Asexual infection recurrence by PCR. 7. Hemoglobin on days 7, 42. 8. Adverse events.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer-generated sequences in blocks of four.
Allocation concealment (selection bias)	Low risk	Opaque envelopes used in order at the health centre.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of differential attrition.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Other bias	Low risk	None detected.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding, no PQ placebo.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information.