Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Inclusion Criteria

• •Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion.
• •Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
• •Subject is able to be treated on an outpatient basis.
• •Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient.
• •Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
• •Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study.