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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