Schellenberg 2001 TZA.

Study characteristics
Methods	Trial design: RCT Trial dates: August 1999 to April 2000 Length of follow‐up: 24 months of age
Participants	Number of participants: 701 infants (350 versus 351) Inclusion criteria: infants have just received second dose of DPT and oral poliovirus vaccine Exclusion criteria: illness requiring hospital admission
Interventions	Intervention: IPTi with SP (25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine) first dose at 2 months, second dose at 3 months, and third at 9 months with 1/4 tablet for children < 5 kg, 1/2 tablet for children 5 to 10 kg, or 1 tablet for children > 10 kg Placebo: identical placebos (consisting of lactose and maize starch) were also administered according to body weight as for IPTi
Outcomes	Outcomes included in the review Clinical malaria All‐cause mortality Hospital admissions Anaemia Adverse events Outcomes not included in the review Serological responses to EPI vaccines Outpatient visits
Notes	Location: Ifakara, Tanzania Malaria transmission: perennial/holoendemic Funding: UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR); Spanish Agency for International Cooperation (AECI); Fondo de Investigaciones Sanitarias (FIS number 00/0803); Swiss Agency for Development and Cooperation; Hoffman‐La Roche provided the SP and placebo, and UNICEF provided the iron syrup.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial computer‐generated the sequence generation
Allocation concealment (selection bias)	Low risk	The trial used sealed, opaque envelopes and identical, centrally coded drugs and placebo
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No other project staff had ready access to treatment allocation information besides the health assistant who was not involved in the trial.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No other project staff had ready access to treatment allocation information besides the health assistant who was not involved in the trial.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The percentage loss was 3%
Selective reporting (reporting bias)	Low risk	The trial authors reported key outcomes
Other bias	Low risk	The trial appeared to be free of other sources of bias

Abbreviations: AIDS: acquired immunodeficiency syndrome; AQ: amodiaquine; AS: artesunate; DHAP: dihydroartemisinin‐piperaquine; DPT:diphtheria‐pertussis‐tetanus; ECG: electrocardiogram; EIR: entomological inoculation rate; EPI: expanded programme on immunization; HIV: human immunodeficiency virus; ICC: intracluster correlation coefficient; IPTi: intermittent preventive treatment in infants; ITN: insecticide‐treated net; OPV: oral poliovirus vaccine; PENT: pentavalent vaccine; RCT: randomized controlled trial; SP: sulfadoxine pyrimethamine.