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Table 4 Simulated trial operating characteristics

From: Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol

Scenario %. %. Power Mean    Mean trial
  Finish Finish   Subjects % Group 1 % Group 2 (Weeks)
  Early Late      
#1. very likely (4 vs 1%)a 82% 8% 90% 938 40% 60% 184
#2. likely (3 vs 0.5%) 84% 7% 91% 934 41% 59% 184
#3. unlikely (3 vs 1%) 52% 11% 63% 1046 44% 56% 204
#4. very unlikely (3 vs 2%) 23% 4% 27% 1142 46% 54% 221
#5. no difference (3 vs 3%) 5% 0% 5% 1188 51% 49% 231
  1. aBased on our planned enrollment and US 2012 ePTB rates of black and white pregnancies, we anticipate 4.1% ePTB in the control group