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Mother-infant pairs were offered clinical, nutritional and psychosocial follow-up in study clinics from birth to two years.
Clinical interview and functional assessment were performed at the study clinics located in each town.
The endpoint was clinical malaria, as defined above, detected passively at one of the study clinics.
If eligible, women were referred to one of two study clinics in Kumasi or Accra.
The rationale for selection of study clinics is described below in statistical considerations.
Clinical follow-up of infants from birth to two years took place in study clinics.
Women were counseled to use an effective contraceptive method and could receive free hormonal contraception at the study clinics.
Study clinics screened potential study participants for HIV-1 using paired commercial HIV-1 rapid tests run in parallel.
The six additional study clinics were not included in the calculation of the coefficient of variation for 18-month mortality.
This mainly reflected patients living outside the study area, or patients visiting the study clinics outside study days.
This resulted largely from the irregularity of routine patient visits to the study clinics and the difficulty of locating and interviewing patients who present at unscheduled times.
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