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Intensity of adverse events reported as being related to the investigational product
| One intake N = 161 | Two intakes N = 155 | |||||
| AE intensity/type | Mild | Moderate | Severe | Mild | Moderate | Severe |
| Gastrointestinal | 1 | 4 | 0 | 2 | 1 | 0 |
| Abdominal pain | 0 | 2 | 0 | 0 | 1 | 0 |
| Duodenal ulcer | 0 | 1 | 0 | 0 | 0 | 0 |
| Nausea | 1 | 1 | 0 | 2 | 0 | 0 |
| Nervous system | 0 | 0 | 1 | 3 | 0 | 0 |
| Dysgeusia | 0 | 0 | 0 | 1 | 0 | 0 |
| Drowsiness | 0 | 0 | 0 | 2 | 0 | 0 |
| Seizures | 0 | 0 | 1 | 0 | 0 | 0 |
| Skin | 4 | 1 | 0 | 2 | 1 | 0 |
| Pruritus | 3 | 0 | 0 | 0 | 1 | 0 |
| Generalized pruritus | 1 | 1 | 0 | 2 | 0 | 0 |
| Total | 5 | 5 | 1 | 7 | 2 | 0 |
