Döpfner 2011a, OBSEER.

Methods	The OBSEER study (Observation of Safety and Effectiveness of Equsym XL in Routine Care). A non‐interventional, non‐controlled, multicentre, prospective, observational, postmarketing surveillance study
Participants	Number of participants screened: 852 Number of participants included: 822 Number of participants followed up: 777 (completed all 3 planned visits) Number of withdrawals: 45 Diagnosis of ADHD: ICD‐10; F90.0 430 (55.41%), F90.1 282 (36.34%), F90.8 64 (8.25%) Age: mean 10.04 (SD 2.47) years (range 6‐17) IQ: above 70 Sex: 663 males (81.25%), 153 females (18.75%) Methylphenidate‐naïve: 30.17% Ethnicity: not stated Country: Germany Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria Confirmed diagnosis of ADHD according to DSM‐IV‐TR (314.00 or 314.01) or ICD‐10 (F90.0, F90.1 or F90.8) Therapy with Equasym XL already intended by the attending physician Patients had to be attending school Exclusion criteria Contraindications according to the summary of product characteristics Presence of a mental handicap
Interventions	Methylphenidate type: once‐daily modified‐release methylphenidate, Equasym XL (30% immediate‐release‐ and 70% modified‐release methylphenidate) Methylphenidate dosage: 10 mg ‐ 120 mg, maximum recommended daily dose (60 mg/day) exceeded in 6 patients Administration schedule: once daily Duration of intervention: 5 days to 12 months (mean 2.26 months) Treatment compliance: not stated
Outcomes	Adverse events (AEs) were evaluated by the treating physician at each study visit, and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 11.1 and classified into AEs and serious AEs (death, life‐threatening conditions, hospitalisation or prolongation of hospitalisation, persistent injury/disability, incapacity for work, medically significant conditions and congenital abnormalities/birth defects) DAYAS (The Daily Profile of ADHD Symptoms) completed by teacher and parents at each visit
Notes	Sample calculation: yes Ethics approval: no approval was needed for this study Funding/vested interests/authors' affiliations: the study was funded by UCB and the article (Döpfner 2011) is part of a supplement sponsored Shire Development Inc. Key conclusions from study authors: this open‐label, observational, post‐marketing surveillance study investigates the effectiveness and safety of Equasym XL which is a combination of 30% immediate‐release MPH and 70% modified‐release MPH, in the treatment of ADHD in daily clinical practice. The effectiveness of Equasym XL was rated better than prior or no therapy and generally well tolerated Comments from study authors: limitations on the study: open‐label, no control group: therefore, physicians and parents were not blinded to the study treatment or dose Some of the participants were previously treated with stimulants, therefore the results from this group can only be generalised to a population in which a switch to Equasym XL is planned due to suboptimal effects of the prior medication. This was an open‐label study with no control group, only data on adverse events are therefore extracted Supplemental information regarding data were attempted to retrieve from the authors by email. Sent twice, no answer