Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome

Exclusion Criteria

• •Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
• •Sitting BP that meets the following criteria after 5 minutes of rest at Screening:
• •1. Adult subjects with systolic BP \>/=145 mmHg or \<100 mmHg; or
• •2. Adult subjects with diastolic BP \>/=95 mmHg or \<70 mmHg; or
• •3. Adolescent subjects with a systolic or diastolic BP that is 95th percentile or greater for age and sex
• •Type 1 diabetes mellitus
• •History of dementia (eg, Alzheimer's disease, Parkinson's disease)
• •History of bulimia or anorexia nervosa
• •History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
• •Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
• •Medical condition or recent systemic infection that, in the opinion of the Investigator, could impact the safety of the subject
• •Use of prohibited medications, including current use of SSRIs/SNRIs