Autism Spectrum Disorder Clinical Trials

• Able to provide consent as follows:

‣ The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;

⁃ The patient must provide written assent to study enrollment;

• Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

• Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.

∙ Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.