Most frequent medication related adverse events (safety cohort).

<p>Most frequent medication related adverse events (safety cohort).</p

Immediate tolerability (safety cohort).

<p>Immediate tolerability (safety cohort).</p

Trial profile (modified ITT cohort).

<p>Trial profile (modified ITT cohort).</p

Time to first episode of clinical malaria. ITT cohort. Kaplan Meier graph.

<p>Time to first episode of clinical malaria. ITT cohort. Kaplan Meier graph.</p

Low birth weight (<2,500 g at birth) rates by treatment group and country.

<p>ITT analysis adjusted by country. Interaction country×treatment: χ²: 1.22 with 3 degrees of freedom <i>p</i> = 0.766.</p><p>ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]). Interaction country×treatment: χ²: 0.31 with 3 degrees of freedom <i>p</i> = 0.959.</p><p>Low birth weight (<2,500 g at birth) rates by treatment group and country.</p

Baseline characteristics.

<p>ITT cohort.</p>a<p><i>n</i> (column percentage).</p>b<p>Arithmetic mean (SD) [<i>n</i>].</p>c<p>Median (IQR) [<i>n</i>].</p><p>MUAC, middle upper arm circumference.</p><p>Baseline characteristics.</p

Adverse events by system organ class and treatment group.

<p>N, number of participants with at least one event.</p><p>Adverse events by system organ class and treatment group.</p

List of possibly/probably related SAEs.

<p>List of possibly/probably related SAEs.</p

Incidence of clinical malaria, outpatients visits, and hospital admissions.

a<p>Episodes person/year; ATP analysis adjusted by baseline variables (country, seasonality, gestational age, gravidity, anemia, literacy, and middle upper arm circumference [MUAC]); ITT analysis adjusted by country.</p><p>Incidence of clinical malaria, outpatients visits, and hospital admissions.</p

Birth weight distribution by study country and IPTp group.

<p>Newborn weights not captured at birth but within the first week of life were estimated using a linear regression model.</p