- Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study - Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant - Poor compliance with the visit schedule or medication intake in the previous BRV studies - Planned participation in any other clinical study of another investigational drug or device during this study - Pregnant or lactating woman - Any medical condition which, in the Investigator’s opinion, warrants exclusion - Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months - Study participant has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert’s syndrome)