Single Dose Group [n = 225]

Double Dose Group [n = 225]

P

RR (95%CI)

NNT_(Harm) (95%CI)

Noncompliance

29 (12.9%)

48 (21.3%)

0.02

1.66 (1.09 - 2.53)

11.8 (65.4 - 6.51)

Nausea/Vomiting

7 (3.11%)

11 (4.89%)

0.34

1.57 (0.62 - 3.98)

–

Constipation

24 (10.7%)

41 (18.2%)

0.03

1.71 (1.07 - 2.73)

13.2 (91.1_(Harm) - 7.13_(Harm))

Abdominal pain

9 (4.0%)

14 (6.2%)

0.29

1.56 (0.68 - 3.52)

–

Black staining of the stools

36 (16.0%)

68(30.2%)

<0.001

1.89 (1.32 - 2.71)

7.0 (15.2_(Harm) - 4.56_(Harm))