Author Contributions: Drs Prokocimer and Mehra 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.
Study concept and design: Prokocimer, De Anda, Das.
Acquisition of data: De Anda, Fang, Mehra.
Analysis and interpretation of data: Prokocimer, De Anda, Fang, Das.
Drafting of the manuscript: Prokocimer, De Anda, Fang, Das.
Critical revision of the manuscript for important intellectual content: De Anda, Fang, Mehra.
Statistical analysis: Das.
Administrative, technical, or material support: De Anda, Fang.
Study supervision: Prokocimer, De Anda, Mehra.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Prokocimer, DeAnda, and Fang each reported holding stock/stock options in Trius Therapeutics; and each was an employee at the time the work and analyses were performed. Dr Das reported receiving the following from Trius Therapeutics: consulting fees, support for travel expenses, fees for participating in review activites, and payment for writing or reviewing the manuscript; and serving as a consultant to Cerexa Inc, Achaogen Inc, Nabriva Therapeutics, Durata Therapeutics, Cubist Pharmaceuticals Inc, Cempra Pharmaceuticals Inc, Polymedix Inc, and Kalidex Inc. Dr Mehra reported not having any conflicts of interest.
Funding/Support: Trius Therapeutics funded and conducted the trial.
Role of Sponsor: The author-employees of Trius Therapeutics were responsible for the study concept and design in consultation with Dr Das. Trius Therapeutics compensated Dr Das for her work and engaged contract research organizations (Synteract, Inclin, Trio Clinical Resources, Pharm Olam International, Pharmanet-i3, BioClinica, and EMB Statistical Solutions) for study conduct, monitoring, and data management.
Independent Statistical Analysis: All primary and secondary analyses of efficacy, primary safety results, and conclusions presented in this article have been confirmed by an independent statistical review and analysis performed by Hector Lemus, PhD (Division of Epidemiology and Biostatistics, Graduate School of Public Health, San Diego State University, San Diego, California). Dr Lemus was provided all raw SAS data sets, analysis SAS data sets, the study protocol, the statistical analysis plan, a blank copy of the study case report form, the analysis database specifications, and the original version of the manuscript by the authors and the sponsor of this study. Dr Lemus was in agreement with the statistical methods used in the manuscript and independently verified the primary and secondary efficacy results. The results presented herein are those verified by Dr Lemus, who was compensated by Trius Therapeutics for his statistical review.
Additional Contributions: Gary Witherell, PhD, and Sandra Ruhl, RN (both with Pfluent Inc), were compensated for providing medical writing and editorial assistance. Sharon Dana, PhD, an employee of Trius Therapeutics, assisted with revisions of the manuscript after peer review, and was compensated for her contribution.
This article was corrected for errors on February 14, 2013.