Accepted for Publication: March 22, 2011.
Published Online: June 13, 2011. doi:10.1001/archneurol.2011.146
Author Contributions: All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis; the SPARCL steering committee developed the study protocol with the sponsor and takes responsibility for the data and data analyses. Study concept and design: Callahan, Amarenco, Sillesen, MacLeod, and Welch. Acquisition of data: Callahan, Amarenco, Altafullah, Ledbetter, MacLeod, Zivin, and Welch. Analysis and interpretation of data: Callahan, Amarenco, Goldstein, Messig, Samsa, Altafullah, MacLeod, Scott, Hennerici, and Welch. Drafting of the manuscript: Callahan, Scott, and Zivin. Critical revision of the manuscript for important intellectual content: Callahan, Amarenco, Goldstein, Sillesen, Messig, Samsa, Altafullah, Ledbetter, MacLeod, Scott, Hennerici, Zivin, and Welch. Statistical analysis: Messig and Samsa. Obtained funding: Zivin. Administrative, technical, and material support: Ledbetter. Study supervision: Callahan, Sillesen, Hennerici, and Welch.
Financial Disclosure: Dr Callahan has received research grant support from Pfizer and honoraria from Pfizer, sanofi-aventis, and Bristol-Myers Squibb. Dr Amarenco has received consulting fees from AstraZeneca, Bristol-Myers Squibb, Daiichi, Eli Lilly, GlaxoSmithKline, Guerbet, Negma, Novartis, Pfizer, Sankyo, sanofi-aventis, and Servier; lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Otsuka Pharmaceutical, Pfizer, sanofi-aventis, and Servier; and grant support from Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Pfizer, and sanofi-aventis. Dr Goldstein has received consultancy fees and honoraria from Pfizer. Dr Sillesen has received consulting fees from Pfizer and sanofi-aventis; lecture fees from AstraZeneca, Bristol-Myers Squibb, Merck, Pfizer, and sanofi-aventis; and grant support from Pfizer. Dr Messig is an employee of Pfizer and owns stock in Pfizer. Dr Samsa has received consultancy fees from Boehringer Ingelheim. Dr Altafullah has received honoraria and research support from Pfizer; has been part of the speaker's bureau of Pfizer; and owns stock in Pfizer. Dr Hennerici has received research grant support from Pfizer. Dr Zivin has received consulting fees from Ambit, AstraZeneca, CytRx, Merck, Johnson & Johnson, PhotoThera, PhRMA, Pfizer, and Remedy Pharmaceutical. Dr Welch has received consulting fees from Eisai, GlaxoSmithKline, Medpointe/AstraZeneca NMT Med, Ortho-McNeil, and Pfizer; lecture fees from GlaxoSmithKline and Pfizer; and grant support from Pfizer.
Funding/Support: This study was sponsored by Pfizer Inc.
Role of the Sponsor: Pfizer Inc was involved in the design and conduct of the study; collection, management, and analysis of the data; and review of the manuscript.
Additional Contributions: No content development support was provided, but assistance in preparing the figures and manuscript for submission was provided by Shuang Li, PhD, at UBC Scientific Solutions and was funded by Pfizer Inc. Medpace managed all data. Medpace, Charles River Laboratories Clinical Services, and Pfizer Inc provided site monitoring throughout the study.