Accepted for Publication: July 26, 2013.
Published Online: April 16, 2014. doi:10.1001/jamasurg.2013.4841.
Study concept and design: Bulger, Maier, Joshi, Cohen, Opal, Segalovich, Kaempfer, Shirvan.
Acquisition of data: Bulger, Joshi, Henry, Moore, Moldawer, Demetriades, Talving, Schreiber, Ham, Cohen.
Analysis and interpretation of data: Bulger, Maier, Sperry, Moore, Moldawer, Demetriades, Schreiber, Cohen, Opal, Segalovich, Maislin, Shirvan.
Drafting of the manuscript: Bulger, Demetriades, Ham, Maislin.
Critical revision of the manuscript for important intellectual content: Maier, Sperry, Joshi, Henry, Moore, Moldawer, Demetriades, Talving, Schreiber, Cohen, Opal, Segalovich, Kaempfer, Shirvan.
Statistical analysis: Maislin.
Obtained funding: Maier, Segalovich, Kaempfer, Shirvan.
Administrative, technical, or material support: Bulger, Maier, Henry, Moore, Moldawer, Talving, Schreiber, Cohen, Opal, Segalovich, Kaempfer, Shirvan.
Study supervision: Bulger, Joshi, Moore, Moldawer, Demetriades, Schreiber, Ham, Opal, Segalovich, Shirvan.
Conflict of Interest Disclosures: Dr Bulger currently serves as a consultant to Atox Bio Ltd for subsequent trial design but did not receive any direct support during the conduct of this trial. Dr Joshi was a paid consultant with Atox Bio before this study, starting to review information regarding the product research in clinical trial. Ms Segalovich and Dr Shirvan are employees of Atox Bio. Mr Maislin is principal biostatistician for Biomedical Statistical Consulting, Wynnewood, Pennsylvania, which provided biostatistical services for this project. Dr Kaempfer is an inventor on patents covering p2TA, is a scientific founder of Atox Bio, and serves as its chief scientist.
Funding/Support: Financial support and the drug for this trial was provided by the manufacturer, Atox Bio Ltd.
Role of the Sponsor: Atox Bio Ltd had input into the design of the study and review of the manuscript, for which authorship is identified (Ms Segalovich and Drs Kaempfer and Shirvan are employees of Atox Bio). The statistical analysis was performed by an independent statistician. Atox Bio was not involved in the conduct of the study; management and interpretation of the data; preparation or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We acknowledge the study coordinators at each site: Harborview Medical Center, University of Washington, Seattle; University of Pittsburgh, Pittsburgh, Pennsylvania; University of Maryland, Baltimore; University of Florida, Gainesville; University of Southern California, Los Angeles; and Oregon Health & Science University, Portland.