This study, including the Rapid Service Fee, was sponsored by Biogen (Cambridge, MA, USA).
Medical Writing and/or Editorial Assistance
Biogen provided funding for medical writing support in the development of this paper; Chris Traylen, PhD, and Katherine Ayling-Rouse, MSc, from Excel Scientific Solutions wrote the first draft of the manuscript based on input from authors, and Adrienne Trout, BSc, from Excel Scientific Solutions copyedited and styled the manuscript per journal requirements. Biogen reviewed and provided feedback on the paper to the authors. The authors had full editorial control of the paper and provided their final approval of all content.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Dr. Chinea has received advisory/consulting fees from Biogen, Genentech, Novartis, Sanofi Genzyme, and Teva Neuroscience; research support from Biogen, Novartis, and Sanofi Genzyme; and speaker fees from Biogen, Genentech, Novartis, Sanofi Genzyme, and Teva. Dr. Amezcua has received advisory/consulting fees from Novartis and Genzyme, and research support from Biogen and MedDay. Dr. Vargas has received advisory/consulting fees from Alexion, Biogen, Genentech, and Octapharma, and research support from Teva. Dr. Okai has received advisory/consulting fees from Biogen, Celgene, EMD Serono, Genentech, Genzyme, and TG Therapeutics; support from Biogen, Novartis, Sanofi Genzyme, and TG Therapeutics; and speaker fees from Biogen, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva. Dr. Williams has received advisory/consulting fees from Biogen, Celgene, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva Neuroscience, and speaker fees from Biogen, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva. Drs. Su, Mendoza, Lewin, and Jones are employees of and hold stock/stock options in Biogen. B. Parks was an employee of Biogen at the time the research was conducted. Dr Parks is now employed at Blueprint Medicines, Cambridge, MA, USA.
Compliance with Ethics Guidelines
The study was conducted in accordance with relevant US federal regulations, the Declaration of Helsinki, and the International Council on Harmonisation Guideline for Good Clinical Practice. Approvals were granted by relevant institutional ethics committees for study protocol and amendments, and written assent and consent forms were obtained from each patient and his or her parent or legal guardian. ESTEEM was registered at ClinicalTrials.gov (NCT02047097).
All data generated or analyzed during this interim subgroup analysis are included in this published article/as supplementary information files.
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