| 4.8 g/day n = 727 | 2.4 g/day n = 732 | |
| Patients with AE (%) | 209 (28.7%) | 211 (28.8%) |
| Patients with serious AE (%) | 6 (0.8%) | 13 (1.8%) |
| Patients withdrawn due to AE (%) | 28 (3.9%) | 31 (4.2%) |
| Severity of AE (%) | ||
| Mild | 218 (55.3%) | 257 (62.8%) |
| Moderate | 146 (37.1%) | 121 (29.6%) |
| Severe | 30 (7.6%) | 31 (7.6%) |
| AE relationship to study drug (%) | ||
| Doubtfully related | 266 (67.5%) | 297 (72.6%) |
| Possibly related | 105 (26.6%) | 93 (22.7%) |
| Probably related | 23 (5.8%) | 19 (4.6%) |
| No of serious AE | 8 | 22 |
AE, adverse event.