Haertling 2015.

Methods	A prospective, multicentre, observational cohort study of long‐acting methylphenidate use for 12 weeks
Participants	Number of participants screened: not stated Number of participants included: 262 Number of participants followed up: not stated Number of withdrawals: 23 Diagnosis of ADHD: ICD‐10 (subtype: combined (58%), hyperactive‐impulsive (34%), inattentive (8%)) Age: mean 10.9 (SD 2.5) years old (range: 11‐18) IQ: not stated Sex: 197 males, 63 females, 2 unknown Methylphenidate‐naïve: 19.1% Ethnicity: not stated Country: Germany Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria Definite ADHD diagnosis (DSM‐IV criteria) ADHD symptoms for ≥ 6 months having caused clinically significant impairment in ≥ 2 settings Informed consent by parents and patients Age: 11‐18 years Sufficient ability to read, write, communicate and understand the study procedures Exclusion criteria Contraindications for methylphenidate
Interventions	Methylphenidate type: long‐acting methylphenidate Methylphenidate dosage: start with 20 mg once daily and to adjust in weekly 10 mg increments to a maximum of 60 mg/day Administration schedule: once in the morning Duration of intervention: 12 weeks Treatment compliance: not stated
Outcomes	Measure method/instrument: AEs according to the Medical Dictionary for Regulatory Activities (MedDRA), version 13 A total of 63 AEs were reported in 36 (13.7%) patients. Severity was mild in 30.2%, moderate in 39.7%, and severe in 22.2% of AEs; 7.9% of data were missing. 28 patients had AEs believed to be treatment related (10.7%). By the end of the study, more than half of the AEs had resolved completely The most frequent AEs were loss of appetite, abdominal pain, and nausea. The most frequently affected System Organ Classes were metabolism and nutritional as well as psychiatric and nervous system disorders The number of AE per patient sums up to 4 adverse reactions in 1 patient throughout the whole treatment course (50.79% of all AEs) the outcome was 'resolved'. In 20 AE‐cases (31.75%) the outcome was 'not yet resolved'. In 1 patient the outcome of the AE was not known Serious adverse events 3 (hospitalisation) (0.4% of patients) Non‐serious adverse events: 60
Notes	Sample calculation: not stated Ethics approval: ethics committee approval Funding/vested interest: this study was initiated and sponsored by Novartis Pharma Germany. B Mueller is a full‐time employee of Novartis Pharma GmbH, the market authorisation holder of Ritalin LA. F Haertling received honorariums during the participation of this study. O Bilke‐Hentsch received honorariums as principle investigator of this study Authors' affiliations: Novartis Pharma Key conclusions of the study authors: Ritalin LA improved CGI and quality of life in children with ADHD under routine practice conditions Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated; however, children with poor response to previous treatment plans are included Supplemental information regarding IQ, comedication, comorbidity and additional AE tables requested through personal email correspondence with the authors in June 2016 (Mueller 2016 [pers comm]). The authors were not able to supply the information