Author Contributions: Dr Benjamin 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: Benjamin, Califf, Li.
Acquisition of data: Benjamin, Smith, Murphy, Mathis, Avant, Li.
Analysis and interpretation of data: Benjamin, Roberts, Mathis, Avant, Califf.
Drafting of the manuscript: Benjamin, Li.
Critical revision of the manuscript for important intellectual content: Smith, Murphy, Roberts, Mathis, Avant, Califf, Li.
Statistical analysis: Benjamin.
Obtained funding: Califf.
Administrative, technical, or material support: Smith, Mathis, Avant, Califf, Li.
Study supervision: Murphy, Roberts, Li.
Financial Disclosures: Dr Benjamin reports receiving research support from Cape Cod Associates, Astellas, MedImmune, NABI Biopharmaceutical, the National Institutes of Allergy and Infectious Diseases (NIAID), the National Institutes of Child Health and Human Development (NICHD), Pediatrix, Pfizer, Rockeby, Thrasher Research, and Vicuron; fellowship funding from AstraZeneca and Johnson & Johnson; speaking and consulting honoraria from Enzon, Ligocyte, Ross, and Vicuron. Dr Benjamin does not own any stock or hold financial interest in any of the listed companies. All consulting relationships were terminated with start of joint appointment with the FDA in October 2005. Dr Smith reports receiving research support from Cape Cod Associates and Astellas; and fellowship funding from NICHD and NIAID. Dr Smith does not own any stock or hold financial interest in any of the listed companies. Dr Califf reports personally receiving funding support from Conceptis in excess of $10 000 and has equity in NITROX LLC. The Duke Clinical Research Institute receives institutional research grants and contracts from numerous pharmaceutical companies, of which indirectly benefit Dr Califf. Educational activities or lectures provided by Dr Califf generate revenue for Duke University from the following companies: Aventis, Bristol-Myers Squibb, Conceptis, Guilford Pharmaceuticals, Merck, Novartis, Pfizer, Sanofi-Aventis, Schering Plough, and the Medicines Company. Dr Li reports receiving research support from Bristol-Myers Squibb, Sanofi-Aventis, Pfizer, NICHD, the National Heart Lung and Blood Institute (NHLBI), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), First Horizon, MedImmune, and ID Biomed; and salary support from NICHD, NHLBI, and NIAMS. Dr Li does not own any stock or hold financial interest in any of the listed organizations or companies. No other authors reported any financial disclosures.
Funding/Support: Drs Benjamin and Li received support from NICHD 1U10-HD45962-03 and the FDA.
Role of the Sponsor: The design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript are independent of any funding organization.
Disclaimer: The views expressed are those of the authors. No official endorsement by the FDA is provided or should be inferred. No commercial or other conflict of interest exists between the authors and the pharmaceutical companies.
Acknowledgment: We thank Beverly Murphy, Duke University librarian, for assistance with the EMBASE search strategy. Ms Murphy received no financial compensation for this assistance.