Stern 1990.

Methods	Cross‐over trial of fenfluramine versus placebo
Participants	Inclusion criteria: "infantile autism with or without mental retardation [intellectual disability]" diagnosis based on DSM‐III, previously under the care of paediatricians and paediatric neurologists Exclusion criteria: chromosomal anomalies, including the fragile X chromosome Location/setting: Adelaide Children's hospital, Australia Sample size: 20 in total Number of withdrawals/dropouts: "one child moved to another state half way through the trial" Gender: 14 boys, 6 girls Mean age: 10 years IQ: not reported Baseline ABC‐I or other BoC: not reported Concomitant medications: 15/20 were on no medications, 3 were on anticonvulsants, 1 was on benzodiazepine and 1 was on the contraceptive pill History of previous medications: not reported
Interventions	Intervention (fenfluramine) for 5 months: "the dose of Fenfluramine was 1.5mg/kg/day given twice daily for a 5 month period". At the end of the period all children were given placebo for 2 months before the groups crossed over for a second 5‐month period. Comparator (placebo) for 5 months: All children were given placebo for a month to get used to the routine of taking tablets regularly. The children were then randomised to either fenfluramine or placebo for a 5‐month period. At the end of the period all children were given placebo for 2 months before the groups crossed over for a second 5‐month period.
Outcomes	Primary outcomes: AEs (weight change, measured in kgs) Secondary outcomes: none reported Timing of outcome assessments: not reported
Notes	Study start date: not reported Study end date: not reported Source of funding: "this study was supported by a grant from the Apex Foundation. The authors thank Dr Grant Sutherland for the karyotypes and Mrs Robyn Clements for the manuscript preparation. Fenfluramine and placebo tablets were supplied by Servier Laboratories (Australia) Pty, Ltd." Conflicts of interest: none declared