Abacassamo 2004.

Methods	Randomized open trial Generation of allocation sequence: random permuted block Allocation concealment: not mentioned Blinding: not mentioned Inclusion of all randomized participants: no (113/124) Length of follow up: 21 days
Participants	Number: 124 enrolled, 113 analysed Inclusion criteria: children 6 to 59 months living within the study area; axillary temperature 37.5 ºC to 40 ºC; acute non‐complicated Plasmodium falciparum; parasitaemia 2000 to 100,000 asexual parasites/µL of blood; parent or guardian written informed consent Exclusion criteria: danger signs (not able to drink, eat or breastfeed; severe vomiting – > 2 times in 24 hours; unconscious and unable to sit or stand; signs of severe malaria – cerebral malaria defined as inability to localize pain; severe anaemia – haemoglobin < 5 g/dL or a packed cell volume less < 15% or with spontaneous bleeding and repeated generalized convulsions
Interventions	1. Sulfadoxine‐pyrimethamine (SP) plus amodiaquine (AQ) 2. SP plus artesunate (AS) AQ: 10 mg/kg/day for 3 days AS: 4 mg/kg/day for 3 days SP: 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine Third arm not relevant to review: AQ plus AS
Outcomes	1. Therapeutic response, according World Health Organization (WHO) 1996 definitions (reference in Abacassamo 2004) 2. Presence of fever 3. Gametocyte carriage
Notes	Location: Mozambique Date: February to June 2002 Funding: DBL/INS joint research programme and the WHO/Special Programme for Research and Training in Tropical Diseases (TDR)