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Summary of AEs in VPA arm (safety population)
| Number of patients, n (%) | Placebo (n = 4) | CBD (n = 16) |
|---|---|---|
| At least one AE | 1 (25) | 14 (88) |
| AEs leading to discontinuation | 0 (0) | 2 (13) |
| Serious AEs | 0 (0) | 1 (6) |
| Severe AEs | 0 (0) | 0 (0) |
| Death | 0 (0) | 0 (0) |
| AEs reported by ≥ 10% of patients | ||
| Diarrhea | 0 (0) | 11 (69) |
| Nausea | 0 (0) | 2 (13) |
| Nasopharyngitis | 0 (0) | 2 (13) |
AE treatment-emergent adverse event, CBD cannabidiol, VPA valproate
