- Outpatients who have completed 8 weeks double-blind study (B2411263), without major
protocol violations or tolerability concerns in the opinion of the investigator.
- Clinically important abnormalities on baseline (Week 8 of the double-blind study)
physical examination, or any unresolved clinically significant abnormalities on
electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week
8 in the previous double-blind study.
- Significant risk of suicide based on clinical judgment.
- Use of prohibited treatments