A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

Exclusion Criteria

• •Pregnancy or breastfeeding, or intention to become pregnant during the study
• •Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
• •Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
• •Substance use disorders during the last 12 months
• •Significant risk for suicidal behavior, in the opinion of the investigator
• •Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
• •Clinical diagnosis of peripheral neuropathy
• •Within the last 2 years, unstable or clinically significant cardiovascular disease
• •Uncontrolled hypertension
• •Unexplained syncopal episode within the last 12 months
• •Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
• •Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
• •History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
• •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
• •Confirmed clinically significant abnormality in parameters of hematology
• •Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
• •Medical history of malignancy, if not considered cured