To raise awareness for WorldMentalHealthDay, here is a phase 1b/2 trial involving an oral molecule sequestrant in adolescents living with autism spectrum disorder WMHDay
)) was an open-label, outpatient, multiple-ascending-dose phase 1b/2a study in an ASD-diagnosed adolescent population with confirmed GI symptoms . Forty-one individuals were screened between 18 April 2019 and 23 January 2020. Thirty participants were enrolled across three sites in Australia and New Zealand, including the Queensland Children’s Hospital in Brisbane , the Brain and Mind Centre in Sydney and Optimal Clinical Trials in Auckland .
The study protocol, investigator brochure, participant information and consent forms, participant-facing questionnaires, recruitment documentation and procedures and documentation regarding the investigatorsʼ experience and qualifications were submitted to Health and Disability Ethics Committees , Children’s Health Queensland Hospital and the Health Service Human Research Ethics Committee and Bellberry Human Research Ethics Committee for ethical review and approval.
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