Figure 1. Observation-time model vs. Live births model to calculate expected background maternal and neonatal deaths over the course of a clinical trial in 1000 pregnant women in Mali.

Assuming a maternal mortality ratio of 418.8 (327.5–519.8) per 100,000 live births, stillbirth rate of 23 (18–42) per 1,000 total births, early neonatal mortality rate of 33.5 (28.1–39.0) per 1,000 live births, and late neonatal mortality rate of 12.4 (9.9–15.5) per 1,000 live births estimated for Mali by recently published systematic analyses [3], [44], [45]. We assume women are recruited at 28 weeks gestation and deliver exactly 12 weeks later. † 50 pregnant women recruited each week over 20 weeks. ‡500 pregnant women recruited each week over 2 weeks.