- Subjects must have completed all phases of one of the four preceding double-blind GAD
- Female must continue to use adequate birth control methods and have a negative serum
pregnancy test within 14 days prior to starting open label treatment.
- Subjects who experienced a serious adverse event during the preceding double-blind
efficacy study that was judged to be related to study medication by the investigator
or the sponsor's medical monitor.
- Individuals who have an ongoing, unresolved, clinically significant medical problem
that, in the judgment of the investigator or the sponsor's medical monitor, would
make it unsafe for the subject to participate in the study.
- Serious suicidal risk per the clinical investigators's judgement.