Warshaw 2010.

Methods	Methylphenidate transdermal system use for 7 weeks. 4 weeks dose optimisation followed by 3 weeks on optimised dose. Follow‐up visit 30 days after last dose
Participants	Number of participants screened: 309 Number of participants included: 305 Number of participants followed up: 260 Number of withdrawals: 45 Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: mean 9.1, range: 6‐12 years old IQ: not stated Sex: 215 males, 90 females Methylphenidate‐naïve: not stated Ethnicity: white (77.7%), African American (11.5%), Asian (0.7%), Hispanic (23.9%), others (10.2%) Country: USA Comorbidity: not stated Comedication: only medication non concomitant with central nervous system effects Sociodemographics: not stated Inclusion criteria Boys and girls aged 6‐12 years, inclusive, who met DSM‐IV‐TR criteria for a primary diagnosis of ADHD At baseline, eligible participants had a total score ≥ 26 on the ADHD Rating Scale‐Version‐IV (ADHD‐RS‐IV) and no comorbid illnesses that could affect safety or tolerability or interfere with the person's participation in the study. At screening and baseline, eligible female participants of childbearing potential had a negative result on a urine pregnancy test, and all included participants' blood pressure measurements were within the 95th percentile for age, gender, and height Exclusion criteria Comorbid psychiatric diagnosis (except oppositional defiant disorder) Risk for suicidal or violent behaviour History of suicide attempt Structural cardiac abnormality, cardiomyopathy, cardiac rhythm abnormality, or other serious cardiac problem History of non‐response to psychostimulants History of seizures during the previous 2 years (except infantile febrile seizures) Tic disorder or conduct disorder Current diagnosis or family history of Gilles de la Tourette syndrome History of substance abuse or dependence Abnormal thyroid function Concurrent illness Treatment with hepatic and/or cytochrome P450 enzyme‐altering agents Concomitant medications with central nervous system effects Skin disease, history of chronic skin disease, or sensitive skin syndrome (defined as participants who often develop nonspecific skin irritancy reactions to bland materials); or clinical signs or symptoms of skin irritation
Interventions	Methylphenidate type: transdermal system Methylphenidate dosage: 10, 15, 20, 30 mg Mean methylphenidate dosage: 20.1 mg Administration schedule: MTS 9 hours per day Duration of intervention: 7 weeks Treatment compliance: 260 (84.1%) completed the study
Outcomes	Non‐serious adverse events: Safety was assessed at each clinic visit (baseline, at weeks 1 through 5, week 7, and week 11) by evaluating adverse events reported spontaneously; analysing changes in vital signs, and conducting physical examinations. Dermal reactions were classified as an adverse event when pharmacologic treatment for the reaction was required Experience of Discomfort scale, Transdermal System Adherence scale, and Dermal Response Scale
Notes	Sample calculation: not stated Ethics approval: yes Funding: the study was funded by Shire Development, Inc., Wayne, Pennsylvania Vested interests/authors' affiliations: Dr Warshaw has served as a consultant to Shire. Dr Squires is a full‐time employee of Shire and a stock shareholder in Johnson & Johnson, Pfizer, and Shire. Dr Li was a full‐time employee of Shire at the time of the study and is now an employee of Cerexa, Inc, Oakland, California. Dr Civil is a full‐time employee of Shire. Dr Paller has served as a consultant to Shire Key conclusions of the study authors: the results of this study indicate that dermal reactions with methylphenidate use were predominantly mild to moderate. Dermal reactions appeared to be of an irritant contact dermatitis form; they dissipated rapidly with time and most resolved with continued treatment. Overall, less than 1% of participants manifested sensitisation to methylphenidate Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental data requested through personal email correspondence with the authors in May 2016 but none were available