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Table 2 Most important inclusion and exclusion criteria of the GOAT trial (for further information see [34])

From: “Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

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
  1. DSM-5 Diagnostic and Statistical Manual, 5th edition
  2. ADI-R Autism Diagnostic Interview-Revised