Kemner 2005 (FOCUS).

Methods	A 3‐week, prospective, open‐label, community‐based, multicentre, randomised, parallel study with 2 arms: Osmotic release oral system methylphenidate Atomoxetine
Participants	Number of participants screened: not stated Number of participants included: 1323 Number of participants randomised to OROS‐MPH: 850 Number of participants followed up: not stated Number of withdrawals: not stated Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (72%%), hyperactive‐impulsive (13%), inattentive (15%)) Regarding the OROS‐MPH group: Age: mean 8.77, range 6‐12 years old IQ: above 70 Sex: 630 males, 219 females Methylphenidate‐naïve: 57.97% Ethnicity: white: 75.12%, African American: 14.74%, Asian: 0.71%, Hispanic: 6.72%, American Indian: 0.24%, others: 2.48% Country: USA Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria: 6‐13 years old ADHD, any subtype DSM‐IV‐TR Investigator‐rated ADHD‐RS score of at least 24 points and a Clinical Global Impression‐Severity of Illness scale (CGI‐S) rating as 'moderately ill' or worse at screening ADHD medication treatment naïve or previously treated with ADHD medication with suboptimal response (judged by the clinician in conjunction with the parents) Exclusion criteria: Eating disorders Substance use disorders Comorbid psychiatric conditions other than oppositional defiant disorder History of seizure, tic disorder, mental retardation, or severe developmental disorder Personal or family history of Tourette syndrome Previous diagnosis of hyperthyroidism or glaucoma Use of medications contraindicated for coadministration with OROS methylphenidate or atomoxetine Known non‐response to treatments indicated for ADHD Occurrence of menarche in girls
Interventions	Methylphenidate type: osmotic release oral system Washout: more than 3 days or 5 half‐lives Investigators were allowed to select starting doses Mean OROS‐MPH starting dose: 21.57 mg Titration: 2 weeks, after randomisation Mean OROS‐MPH dose at week 3: 32.7 mg (12.1) / 1.01 mg/kg (0.45) Mean OROS‐MPH dose at week 3 for the African American patients: 32.8 mg (10.9) Mean OROS‐MPH dose at week 3 for the non‐African American patients: 32.7 mg (12.2) Administration schedule: once daily, in the morning Duration of intervention: 3 weeks Treatment compliance: 92% or higher
Outcomes	Non‐serious adverse events: Blood pressure, heart rate, height and weight were recorded at baseline, week 2 and 3 Spontaneously reported adverse effects by patients, parents or investigators
Notes	The FOCUS study: the Formal Observation of Concerta versUs Strattera, Phase IV study Sample calculation: no Ethics approval: yes Funding/vested interests: supported by funding from McNeil Consumer & Specialty Pharmaceuticals Key conclusions of the study authors: these results suggest greater ADHD symptom improvement with osmotic release oral system methylphenidate compared with atomoxetine Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes, known methylphenidate non‐responders and methylphenidate‐optimal‐responders are excluded Supplemental information requested from the authors and YODA‐team in March and June 2014. No reply