Table 2.
Adverse events comparisons between BSE group and placebo group.
| Adverse Events (AE) | BSE (n= 50) Number (%) |
Placebo (n = 48) Number (%) |
|---|---|---|
| Bloating | 1 (0.02) | 0 (0.0) |
| Burping | 0 (0.0) | 0 (0.0) |
| Diarrhea | 0 (0.0) | 0 (0.0) |
| Nausea/vomiting | 0 (0.0) | 0 (0.0) |
| Bruising | 0 (0.0) | 0 (0.0) |
| Headache | 1 (0.0) | 0 (0.0) |
| Upset Stomach | 0 (0.0) | 0 (0.0) |
| Heartburn | 0 (0.0) | 0 (0.0) |
| Abdominal Pain | 0 (0.0) | 0 (0.0) |
| Muscle Pain | 0 (0.0) | 0 (0.0) |
| Taste Alteration | 0 (0.0) | 1 (0.02) |
| Other1 | 0 (0.0) | 0 (0.0) |
| All2,3 | 2 (0.04) | 1 (0.02) |
1
Other changes to health included back/neck pain and mental health issue.
2
Count of subjects who experienced at least one of the grade 2 adverse events.
3
P value for all adverse events comparing the treatment groups through Fisher’s exact test is 1.00.