Yatawara 2016.

Methods	14‐week cross‐over trial of oxytocin versus placebo
Participants	Inclusion criteria: "children aged between 3 and 8 years of age who met the DSM‐IV‐TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision) criteria for Autistic Disorder, Asperger’s Disorder or Pervasive Developmental Disorder‐Not Otherwise Specified (PDD‐NOS)." Exclusion criteria: "Exclusion criteria included known sensitivity to preservatives in the nasal spray (in particular, E216, E218 and chlorobutanol hemihydrates)." Location/setting: "The study was conducted at the Brain and Mind Centre (BMC), The University of Sydney (Australia)". Number of participants: 39 were randomised, 17 to oxytocin (phase 1); 22 to placebo (phase 1). Number of withdrawals/dropouts: phase 1, 2 were excluded from oxytocin group (adverse reaction (1), competing time commitments (1)); 5 in placebo were excluded (intolerance of nasal spray (2); adverse reaction (1); competing time commitments (1); respiratory illness (1)). An additional person was excluded during phase 2 (oxytocin group). Gender: 27 male, 4 female Mean age (SD) in years: 6.2 (1.7) Mean IQ (SD): non‐verbal IQ 83.6 (24.2) Concomitant medications: atomoxetine (1); melatonin (1); anticonvulsant (2); risperidone (2); selective serotonin reuptake inhibitor (sertraline) (2) History of previous medications: not reported
Interventions	Intervention: oxytocin nasal spray 12 IU twice daily (24 IU daily) for 5 weeks with a 4‐week wash‐out period before starting phase 2 of the trial. Comparator (placebo): equivalent placebo nasal spray twice‐daily for 5 weeks with a 4‐week wash‐out period before starting phase 2 of the trial.
Outcomes	Primary outcomes: repetitive behaviour scale (not clear which subscales); adverse effects Secondary outcomes: none reported Timing of outcome assessments: baseline and endpoint of each phase
Notes	Study start date: October 2010 Study end date:October 2012 Funding: "We acknowledge an National Health Medical Research Council Australian Fellowship (APP 511921) to IBH, an NHMRC Career Development Fellowship (APP 1061922) to AJG and a generous donation by Mr Geoff Stein toward the completion of this trial. These funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication." Conflicts of interest: "the authors declare no conflict of interest"

ABC: Aberrant Behaviour Checklist; AE: adverse effect; BoC: behaviours of concern; CARS: Child Autism Rating Scale; CDC: Centers for Disease Control; CGI: Clinical Global Impression; ICD‐10: International Classification of Diseases, 10th revision; IQ: intelligence quotient; LTFU: loss to follow‐up; M: median; PDD‐(NOS): pervasive developmental disorders (not otherwise specified); SD: standard deviation