Table 4. Adverse events.
| Outcomes | Active N (%) | Control N (%) |
|---|---|---|
| 314 (100%) | 324 (100%) | |
| Number of subjects with at least one adverse event (AEs) | 18 (5.73%) | 22 (6.81%) |
| Diarrhea | 6 | 3 |
| Gas | 1 | 0 |
| Vomiting | 0 | 3 |
| Lack of appetite | 0 | 3 |
| Constipation | 2 | 2 |
| Hives | 1 | 0 |
| Rash | 7 | 10 |
| Other | 5 | 9 |
| Number of subjects with at least one serious adverse event (SAEs)a | 1 | 2 |
a
Active group SAE versus gastro-intestinal virus, participant evaluated in emergency room and discharged, and control included an asthma attack induced from pneumonia, and a viral infection requiring hospitalization because of high fever.