From the *Division of GI Surgery, University Hospital, Nottingham, UK; †Aphton Corporation, Woodland, CA; ‡St. Petersburg Mechnikov State MedicalAcademy, St. Petersburg; §Blokhin Cancer Research Center, Moscow, Russia; ∥Semmelweis University, Budapest, Hungary; ¶Clinical Project Services; #Department of Mathematics and Statistics, Lancaster University, Lancaster; and **Division of GI Surgery, University Hospital, Nottingham, UK.
Received for publication December 7, 2010; accepted June 20, 2011.
Reprints: Paul Broome, MD, Sebastian Gomez 15, 03730 Javea, Spain (e-mail: [email protected]).
This study was supported by Aphton Corporation (Woodland, Calif), which had a major role in the design of the study.
Management, monitoring, and analysis were performed by contract research organizations, employing local monitors to ensure compliance with the International Conference on Harmonisation’s Good Clinical Practice guidelines in each of the 3 countries. All authors had access to the study data and assumed responsibility for the interpretation of the results and the decision to submit for publication.
All investigators received pro rata grants from Aphton Corporation for their participation. A. Gilliam and A. Takhar held company-funded research posts at Queen’s Medical Centre, Nottingham. P. Broome was an employee of Aphton; A. Whitehead and J. Humphreys were consultants to the company.
The authors declare no conflict of interest.