BHV-7000 Open-Label Extension Bipolar Mania Study

Exclusion Criteria

• •1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
• •2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
• •3. Investigator deems subject at imminent risk of danger to others or themself.