Published Online: April 28, 2008 (doi:10.1001/jama.299.19.jrv80007).
Author Contributions: Dr Natanson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Natanson, Wolfe.
Acquisition of data: Natanson, Kern, Wolfe.
Analysis and interpretation of data: Natanson, Kern, Lurie, Wolfe.
Drafting of the manuscript: Natanson, Kern, Lurie, Wolfe.
Critical revision of the manuscript for important intellectual content: Natanson, Lurie, Wolfe.
Statistical analysis: Natanson, Kern, Banks.
Obtained funding: Natanson, Wolfe.
Administrative, technical, or material support: Natanson, Wolfe.
Study supervision: Natanson, Wolfe.
Financial Disclosures: In 2004, Dr Natanson reports being paid $10 000 by Hemosol Inc on a 1-time basis to review a cardiac surgery trial of its HBBS product, Hemolink. There are no other financial conflicts reported for Dr Natanson with manufacturers of these types of products or other blood products. At present, Dr Natanson reports being an unpaid special government consultant to the FDA on the HBBS product Hemopure (Biopure Corp, Cambridge, Massachusetts). None of the other authors reported financial disclosures.
Funding/Support: The Warren G. Magnuson Clinical Center of the National Institutes of Health, Bethesda, Maryland, and Public Citizen, Washington, DC, provided support for this study.
Role of the Sponsor: Public Citizen and the National Institutes of Health had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Disclaimer: The opinions expressed are those of the authors only and do not represent the official position or policies of the National Institutes of Health.
Acknowledgment: Dr Banks, senior mathematical statistician, Critical Care Medicine Department, National Institutes of Health, died unexpectedly during the final stages of writing the manuscript. Dr Banks dedicated his life's work to advancing science; his colleagues mourn his loss.