Table 9 Power to evaluate secondary outcomes

Birthweight (difference of 100 gm)*

928

Birthweight (difference of 200 gm)*

234

Gestational age (difference of 2 days*

2484

Gestational age (difference of 4 days*

622

Pre-eclampsia-Change by 40% from 10% baseline rate

1540

Pre-eclampsia-Change by 50% from 10% baseline rate

948

Severity (50% change from cleft lip with palate to cleft lip only in affected cases with 25% overall cleft prevention)

680

Miscarriage (30% change from 15% baseline rate)

1629

Miscarriage (50% change from 15% baseline rate)

562

* Assumes SD of 543 grams (birthweight) and 17.8 days (gestational age) as estimated in our studies in these populations.