Table 2 Most important inclusion and exclusion criteria of the GOAT trial (for further information see [34])
Most important inclusion criteria | Most important exclusion criteria |
|---|---|
- Aged 6 years (ASD patients)/8 years (OCD patients) to 17 years 9 months at initial inclusion - IQ ≥ 70 (based on Wechsler scales, four subtests) - Ability to speak and comprehend the native language of the country in which the assessments take place - DSM-5 diagnosis of OCD (according to a structured interview) and/or ASD (according to ADI-R) | - Intellectual disability (IQ < 70) - Subject has taken another investigational product or taken part in a clinical study with 30 days prior to screening - History of or present clinically relevant somatic acute or chronic disorder that might confound the results of tolerability/safety assessment or would not be in the best interest of the patient |