Accepted for Publication: May 10, 2011.
Author Contributions:Study concept and design: Cheriyan, Wolansky, Cook, and Cadavid. Acquisition of data: Cheriyan, Wolansky, and Cook. Analysis and interpretation of data: Kim, Wolansky, Cook, and Cadavid. Drafting of the manuscript: Cheriyan, Kim, and Cadavid. Critical revision of the manuscript for important intellectual content: Cheriyan, Kim, Wolansky, Cook, and Cadavid. Statistical analysis: Kim. Obtained funding: Wolansky, Cook, and Cadavid. Administrative, technical, and material support: Cheriyan, Wolansky, Cook, and Cadavid. Study supervision: Wolansky and Cadavid.
Financial Disclosure: Dr Wolansky was a full-time employee of CoreLab Partners Inc, Princeton, New Jersey. Dr Cook has served as a consultant and received honoraria from Merck Serono, Bayer Healthcare, Biogen Idec, and Genmab. He has also served on research steering committees for Merck Serono (CLARITY), Bayer Healthcare (BEYOND), and Genmab. Drs Wolansky and Cadavid have had some of their academic salary while at the University of Medicine and Dentistry of New Jersey supported by the clinical trial contract. Drs Cook and Cadavid received honoraria from the sponsor during the course of the study. Dr Cadavid has been a full-time employee of Biogen Idec, a competitor of the manufacturers of interferon beta-1b and glatiramer acetate, since May 2008. None of the work on the BECOME study was done as part of the employment of Dr Cadavid at Biogen Idec or Dr Wolansky at CoreLab Partners.
Funding/Support: The BECOME study was supported by Bayer Schering Pharma, distributors of interferon beta-1b, but was investigator initiated and remains the intellectual property of the New Jersey Medical School, University of Medicine and Dentistry of New Jersey.
Role of the Sponsor: Bayer Schering Pharma was allowed to comment on data interpretation and had the opportunity to review and comment on the final manuscript prior to submission. Bayer Schering Pharma did not participate in the conduct of the study, data collection, data management, data analysis, or preparation of the manuscript.
Additional Contributions: We thank Andrew Laine, DSc, and Noah Lee, MS, MPhil, from the Heffner Biomedical Imaging Laboratory, Department of Biomedical Engineering, Columbia University, New York, New York, for their advice on brain MRI segmentation during the initial stages of this project.