ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

Inclusion Criteria:

• Has completed Study ML-004-002 within the past 90 days

• Age 12 years to 46 years at screening

• Has a designated care/study partner who can reliably report on symptoms

• Has a diagnosis of Autism Spectrum Disorder (ASD)

• Has a body mass index (BMI) ≥18 kg/m²

• Psychoactive medications and adjunctive therapies stable for 4 weeks prior toscreening

• Must be able to swallow study medication

Exclusion Criteria:

• Has Rett syndrome or Child Disintegrative Disorder

• History of epilepsy without current adequate control, or any seizure in the 6 monthspreceding screening

• Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk forsuicidal behavior

• Has a clinical history of uncontrolled or severe hypertension

• If female, is pregnant or lactating