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Nonserious Treatment-Emergent Adverse Events (TEAEs) in ≥5% of Patients in Either Treatment Group (Safety Analysis Set)
| TEAE | Quetiapine XR (n=92) | Placebo (n=100) |
|---|---|---|
| Headache | 20 (21.7) | 12 (12.0) |
| Sedation | 7 (7.6) | 6 (6.0) |
| Dizziness | 6 (6.5) | 2 (2.0) |
| Somnolence | 6 (6.5) | 4 (4.0) |
| Diarrhea | 5 (5.4) | 1 (1.0) |
| Fatigue | 5 (5.4) | 2 (2.0) |
| Nausea | 5 (5.4) | 1 (1.0) |
| Irritability | 2 (2.2) | 5 (5.0) |
XR, extended release.
