To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication

Inclusion Criteria:

• Participants previously diagnosed with ASD (DSM-5)
• Available well-documented health records within the first 2 years of life
• Participants must have a parent or reliable caregiver who agrees to provide information about the participant
• Participants willing and consenting or assenting to participate.

Exclusion Criteria:

• Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
• If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.

Male or female individuals with an autism diagnosis as defined by the DSM-5, adults (from 18 to 65 years of age, inclusive) and adolescents (from 12 to 17 years of age, inclusive).