| FeSO4 n = 74 | Placebo n = 71 | Absolute difference | Significance level Fisher's exact test |
---|---|---|---|---|
Undesirable events, n (%) | Â | Â | Â | Â |
   Hard stools | 13 (17.6%) | 3 (4.2%) | 13.4% | P = 0.015 |
   Liquid stools | 9 (12.2%) | 3 (4.2%) | 8.0% | P = 0.130 |
   Abdominal pain | 7 (9.5%) | 4 (5.6%) | 3.9% | P = 0.534 |
   Nausea | 2 (2.7%) | 0 (0%) | 2.7% | P = 0.497 |
   Any gastrointestinal | 25 (33.8%) | 8 (11.3%) | 22.5% | P = 0.001 |
   Other events | 6 (8.1%) | 3 (4.2%) | 3.9% | P = 0.495 |
   Any event | 29 (39.2%) | 11 (15.5%) | 23.7% | P = 0.002 |
Days with correct dosing (compliance)a | Â | Â | Â | Â |
   Mean (SD) | 26.3 (3.9) | 26.5 (2.8) | -0.2 | P = 0.624 |
   Median (range) | 27 (7 to 35) | 27 (13 to 35) | 0 |  |
Believed to have received b n (%) | Â | Â | Â | Â |
   FeSO4 | 44 (60.3%) | 9 (12.9%) | 37.4% | P < 0.001 |
   Placebo | 13 (18.8%) | 42 (60.0%) | 41.2% |  |
   Does not know | 16 (21.9%) | 19 (27.1%) | 5.2% |  |