Gau 2006.

Methods	An open, randomised, parallel, active‐controlled equivalent 28 day trial with Immediate release methylphenidate Osmotic release oral system (OROS) methylphenidate
Participants	Number of participants screened: not stated Number of participants included: 64 Number randomised to immediate release methylphenidate: 32, and to OROS methylphenidate: 32 Number followed up in each arm: immediate release methylphenidate: 32, OROS methylphenidate: 32 Number of withdrawals in each arm: 0 Diagnosis of ADHD: DSM‐IV/ICD‐10 (combined 50 (78.1%), hyperactive‐impulsive 2 (3.1%), inattentive 12 (18.9%)) Age: mean: 10.5, range: 6‐15 years old IQ: > 80 Sex: 58 males, 6 females Methylphenidate‐naïve: 0 Ethnicity: Asian 100% Country: Taiwan Comorbidity: no Comedication: no Sociodemographics: parents education: college: 55%, high school: 30%, junior high school: 10%, other: 5% Inclusion criteria Been taking methylphenidate 10‐40 mg for the past 3 months Able to comply with the study visit schedules Their mothers and teacher were willing and able to complete the weekly assessments Exclusion criteria Significant gastrointestinal problems A history of hypertension Known hypersensitivity to methylphenidate Co‐existing medical condition Concurrent medication (such as monoamine oxidase inhibitors, and medicines used to treat depression, prevent seizure, or prevent blood clots) likely to interfere with the safe administration of methylphenidate Glaucoma, Tourette syndrome, active seizure disorder or psychotic disorder Girls who had reached menarche
Interventions	Methylphenidate type: immediate release and osmotic release oral system methylphenidate Mean methylphenidate dosage: OROS: 27.7 mg/day (SD 13.5); immediate release: 26.7 mg/day (SD 7.6) Administration schedule: OROS: once daily; immediate release: 3 times daily Duration of intervention: 28 days Treatment compliance: parents were required to record the time of drug administration on an adherence sheet. Pill counting was performed for each participant. Days forgetting to take medication: immediate release group 8.6 (SD 5.7); OROS group 2.0 (SD 3.9)
Outcomes	Non‐serious adverse events: Barkley's Side Effects Questionnaire at baseline, on day 14 and day 28 Vital signs. At baseline, on day 14 and day 28
Notes	Sample calculation: no Ethics approval: IRB of National Taiwan University Hospital Funding/vested interest/authors' affiliations: the study was supported by Janssen‐Cilag, Taiwan. Drs. Susan S.F. Gau and Wei‐Tsuen Soong have conducted clinical trials on behalf of Janssen‐Cilag, Taiwan and Eli Lilly and Company, Taiwan. They have also been speakers for Janssen‐Cilag, Taiwan and Eli Lilly and Company, Taiwan Any withdrawals due to adverse events: no Key conclusions of the study authors: OROS methylphenidate has similar efficacy to immediate release methylphenidate, with less severity of decreased appetite. OROS methylphenidate is superior over immediate release methylphenidate in treating ADHD children and adolescents in the context of Chinese culture Comments from the study authors: the short study period limits our understanding regarding long‐term efficacy of methylphenidate and the possible side effects on appetite, cardiovascular functioning, and so on in the Chinese population Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information regarding IQ and diagnostic criteria received through personal email correspondence with the authors in October 2013 (Gau 2013 [pers comm])