Author Contributions: Dr Hooton 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: Hooton, Roberts, Stapleton.
Acquisition of data: Hooton, Stapleton.
Analysis and interpretation of data: Hooton, Roberts, Stapleton.
Drafting of the manuscript: Hooton, Roberts, Stapleton.
Critical revision of the manuscript for important intellectual content: Hooton, Roberts, Stapleton.
Statistical analysis: Roberts.
Obtained funding: Hooton, Stapleton.
Administrative, technical, or material support: Hooton, Stapleton.
Study supervision: Hooton, Stapleton.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Hooton reported that he has been a consultant for Pinnacle Pharmaceuticals, Pfizer Inc, and Alita Pharmaceuticals. No other author reported disclosures.
Funding/Support: This work was supported by grants P01 DK053369 and SCOR P50 DK64540 from the National Institute of Diabetes and Digestive and Kidney Diseases.
Role of the Sponsors: The funding source did not play any role in the design and conduct of the study; in the collection, management, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.
Previous Presentations: Presented in part at the 47th Annual Meeting of the Infectious Diseases Society of America; October 29-November 1, 2009; Philadelphia, Pennsylvania.
Additional Contributions: We greatly appreciate the involvement of Walter E. Stamm, MD (deceased) in discussions leading to the conception, conduct, and completion of this study. We are greatly indebted to D. C. Dugdale, MD, medical director, and the staff at Hall Health Primary Care Center (University of Washington, Seattle) for assistance with study enrollment; Niki Deshaw, MA, and Ellen Cassen, ARNP, for participant enrollment and follow-up; Marsha Cox, BS, and Sheila Manuguid, BS, for laboratory assistance at the University of Washington, Seattle; Wisvline Labrousse, PhD, ARNP, for participant enrollment and follow-up; and Nadege Atis, BS, for laboratory assistance at the University of Miami, Miami, Florida. All of these individuals were salaried employees of their respective institutions and no one received additional compensation for their efforts in this study.