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Pooled top 10 treatment-emergent adverse-events occurring in 5% or more of patients.
| AE | Placebo (n = 101) n (%) | Aripiprazole (n = 212) n (%) |
|---|---|---|
| Sedation | 4 (3.96) | 44 (20.75) |
| Fatigue | 2 (1.98) | 35 (16.51) |
| Vomiting | 6 (5.94) | 29 (13.68) |
| Increased appetite | 7 (6.93) | 27 (12.74) |
| Somnolence | 4 (3.96) | 22 (10.38) |
| Tremor | 0 (0) | 21 (9.91) |
| Pyrexia | 1 (0.99) | 19 (8.96) |
| Drooling | 0 (0) | 19 (8.96) |
| Headache | 10 (9.90) | 16 (7.55) |
| Extrapyramidal disorder | 0 (0) | 13 (6.13) |
