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Table 1 Statistical power for primary outcomes of preeclampsia and preterm birth for each trial site based on a one-sided test with a type I error rate of 0.05 (India = 11,000 participants; Tanzania 11,000 participants)

From: Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania

 

Cumulative incidence of preeclampsia in standard high-dose calcium group (1500 mg/day)

1.5%

3%

5%

Statistical power for preeclampsia

Noninferiority margin—relative risk of 1.54

95.3%

99.9%

> 99.9%

 

Proportion of preterm (< 37 weeks) in standard high-dose calcium group (1500 mg/day)

10.0%

12.5%

13.5%

Statistical power for preterm birth

Noninferiority margin—relative risk of 1.16

84.3%

91.4%

93.3%