Zheng 2015.

Methods	A 12‐week, prospective, multicentre, open‐label, self‐controlled clinical study of methylphenidate use for 12 weeks
Participants	Number of participants screened: not stated Number of participants included: 153 Number of participants followed up: 123 Number of withdrawals: 30 Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: mean 9.2 (SD 1.5) years old (range 6‐12) IQ: 85 or more Sex: 108 males, 20 females Methylphenidate‐naïve: 90.4% Ethnicity: Han (96.9%), others (3.1%) Country: China Comorbidity: not stated Comedication: none Sociodemographics: not stated Inclusion criteria: Boys and girls between 6 and 12 years of age Normal intelligence (IQ of 85 or more) A documented diagnosis of ADHD according to DSM‐IV Weight 20‐60 kg Academic performance of the previous term Children having no history of taking psychotropic drugs in the last 6 months Currently taking effective MPH‐IR (≤ 60 mg/d) Exclusion criteria: Evidence of any bipolar I or II affective disorder, anxiety disorder, general development disorder, schizophrenia, glaucoma, Tourette syndrome, hypertension and cardiovascular disease Any physical disease that can significantly reinforce the activity of the sympathetic nervous systems, serious gastrointestinal stenosis, dysphagia, and other serious somatic diseases Not being able to coordinate with the cognitive examination Highly sensitive to methylphenidate Had taken or taking sympathomimetic agents such as β‐adrenoreceptor blocking drugs, received or receiving monoamine oxidase inhibitor drugs such as clonidine, other α‐2 adrenergic receptor agonist, tricyclic antidepressants, theophylline, or bishydroxycoumarin in the past 30 days History of drug or alcohol dependence
Interventions	Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: during the optimised treatment phase (weeks 3‐12), 73.5% children received OROS methylphenidate 18 mg once daily and 26.5% received 36 mg once daily (weeks 7‐12) Administration schedule: once daily Duration of intervention: 12 weeks Treatment compliance: the mean course of OROS methylphenidate treatment was 80.1 days and total compliance was 93.6%
Outcomes	Children had a general physical and blood examination (if required) before initiating OROS methylphenidate. Blood pressure, pulse rate, concomitant medications, adverse events (AEs), and treatment review were conducted at baseline and at each visit. A total of 149 patients were included in the safety analysis set
Notes	Sample calculation: not stated Ethics approval: yes Funding/vested interest: the study presented in this report was supported by Xi'an Janssen Pharmaceutical Ltd. Authors' affiliations: Ms. Jian‐Min Zhuo and Dr Sheng‐Nan Xie are full‐time salaried employees of Xi'an‐Janssen Pharmaceutical Ltd. Drs. Yi Zheng, Hong‐Yun Gao, Zhi‐Wei Yang, Fu‐Jun Jia, Fang Fang, and Rong Li have served on advisory boards of Xi'an Janssen Pharmaceutical Ltd., and Eli Lilly and Company Key conclusions of the study authors: in conclusion, this open‐label study suggests that the OROS methylphenidate improves academic and cognitive performance in Chinese school‐aged children with ADHD. The treatment was safe and generally well‐tolerated over the period of 12 weeks Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: see exclusion criteria 4