Table 3 Per Protocol analysis of pregnancy outcomes for women randomized in the trial using Poisson regression analysis with robust error estimation (crude and adjusted incident rate ratios)

11.9 (28/235)

9.6 (13/136)

0.80 (0.42 - 1.49)

0.84 (0.45 - 1.54)

46.1 (119/258)

50.7 (75/148)

1.09 (0.89 - 1.35)

1.12 (0.91 - 1.38)

2.3 (6/258)

1.4 (2/148)

0.58 (0.12 - 2.84)

0.63 (0.12 - 3.46)

11.3 (29/257)

9.5 (14/148)

0.83 (0.46 - 1.53)

0.77 (0.43 - 1.35)

1.2 (3/257)

2.0 (3/148)

1.73 (0.35 - 8.51)

1.56 (0.34 - 7.10)

1.2 (3/257)

2.7 (4/148)

2.31 (0.5 - 10.22)

2.32 (0.47 - 11.36)

1.3 (2/136)

1.5 (2/136)

1.15 (0.19 - 6.82)

1.29 (0.21 - 7.99)

19.2 (9/47)

13.6 (3/22)

0.71 (0.21 - 2.39)

0.78 (0.22 - 2.72)

63.5 (33/52)

58.3 (14/24)

0.92 (0.62 - 1.36)

1.00 (0.68 - 1.49)

3.9 (2/52)

0

-

-

17.3 (9/52)

12.5 (3/24)

0.72 (0.21 - 2.45)

0.56 (0.15 - 2.09)

3.9 (2/52)

4.2 (1/24)

1.08 (0.10 - 11.52)

0.31 (0.08 - 1.25)

1.9 (1/52)

0

-

-

4.3 (2/47)

0

-

-

15.4 (12/78)

11.5 (6/52)

0.75 (0.29 -1.87)

0.81 (0.32 - 2.01)

41.7 (35/84)

43.9 (25/57)

1.05 (0.71 - 1.55)

1.10 (0.73 - 1.66)

2.4 (2/84)

1.8 (1/57)

0.89 (0.06 - 8.00)

0.92 (0.10 - 8.77)

15.5 (13/84)

12.3 (7/57)

0.79 (0.34 - 1.87)

0.77 (0.35 - 1.68)

0

1.8 (1/57)

-

-

0

5.3 (3/57)

-

-

0

0.8 (1/130)

-

-

6.4 (7/110)

6.5 (4/62)

1.01 (0.31 - 3.34)

1.09 (0.32 - 3.68)

41.8 (51/122)

53.7 (36/67)

1.28 (0.95 - 1.75)

1.26 (0.92 - 1.71)

1.6 (2/122)

1.5 (1/67)

0.91 (0.08 - 9.91)

-

5.8 (7/121)

5.9 (4/67)

0.72 (0.21 - 2.45)

-

0.8 (1/121)

1.5 (1/67)

-

-

1.6 (2/121)

1.5 (1/67)

0.90 (0.08 - 9.83)

0.77 (0.04 - 15.87)

0.9 (1/110)

1.6 (1/62)

1.77 (0.11 - 2.80)

-