- Outpatients who have completed 8-weeks of treatment in the preceding study,
3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term
treatment.
- Study participants who are not surgically sterile or postmenopausal must agree and
commit to the use of a reliable method of birth control for the duration of the study
and for 15 days after the last dose of test article. Sexually active study
participants must agree and commit to the use of condoms in addition to other
contraceptive methods.
- Clinically important abnormalities on baseline physical examination or any clinically
significant abnormality on electrocardiogram (ECG), laboratory test results, or vital
signs recorded before the final study day (day 56 visit) of the preceding study
3151A6-2000.
- Unresolved clinically significant adverse events or serious adverse events in the
preceding study 3151A6-2000.
- Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator
and the medical monitor.
- Other exclusion criteria apply.