The study was carried in collaboration with the EPI unit of the Department of State for Health, National Malaria Control Programme and NBR District Health Team. During the preparatory phase of the study, the design and objectives of the study were discussed extensively with the NBR District Team and all health care providers working in the study area. The study team visited all the villages in the study area to explain the objectives of the trial to village elders, opinion leaders, and heads of women's groups, village health workers and traditional birth attendants. This was followed by village meetings, at which the entire community was invited to participate. During these meetings, agreement to participate in the study was obtained from the villagers. In addition, parents or guardians of prospective study subjects in the right age group were visited at home and they were provided with flyers in English and the appropriate local language (Mandinka, Wollof or Fula). Written informed consent was obtained from the parent(s) or guardian(s) before a child was enrolled in the study. Enrolled subjects were provided with a treatment card stamped with a label carrying their name and study number to facilitate identification at each contact.