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Table 1 Inclusion and exclusion criteria for study participation

From: Cannabinoid treatment for autism: a proof-of-concept randomized trial

Inclusion criteria 1. Male or female outpatients aged 5–21 years olda
2. Diagnosis of ASD according to Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition; DSM-5]
3. Moderate or greater behavioral problems as measured by a Clinical Global Impression Scale—Severity (CGI-S) score of 4 or higher at screeningb
4. Involvement of a parent or caregiver able to consistently complete assessments throughout the study
Exclusion criteria 1. Lifetime history of psychotic disorder
2. Current or former treatment with cannabinoids
3. A medical condition (such as heart, liver, renal or hematological disorder) that impacts the subject's ability to participate in the study or makes the subject predisposed to severe adverse events
4. Subjects who have had changes in pharmacological, educational, or behavioral treatments for 4 weeks prior to randomization or planned changes in existing interventions for the duration of the trial
  1. aIn Israel, special education programs for individuals with ASD and neuropediatric clinics continue to follow patients with ASD until they are 21 years old
  2. bTo assign CGI-S scores, structured criteria were used to rate behavioral difficulties on the CGI-S, rather than overall ASD severity