Study concept and design: Toouli, Kow, Knudson, Tweden, Shikora, Sarr, Billington.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Miller, Knudson, Tweden, Shikora, Sarr, Billington.
Critical revision of the manuscript for important intellectual content: Ikramuddin, Blackstone, A Brancatisano, Toouli, Wolfe, Fujioka, Maher, Swain, Que, Morton, Leslie, R Brancatisano, Kow, O’Rourke, Deveney, Takata, Miller, Knudson, Tweden, Shikora, Sarr, Billington.
Statistical analysis: Miller.
Obtained funding: Knudson.
Administrative, technical, or material support: All authors.
Study supervision: Ikramuddin, Blackstone, A Brancatisano, Toouli, Shah, Wolfe, Fujioka, Maher, Swain, Que, Morton, Tweden, Shikora, Sarr, Billington.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ikramuddin reported that he serves on the advisory board for Novo Nordisk Inc and Medica; has served as a consultant for Metamodix Inc and on an expert panel for OptumHealth; and has received grant support from USGI Medical Inc, ReShape Medical, and Covidien. Dr Brancatisano reported that he is a consultant for EnteroMedics. Mr Miller reports consulting support from EnteroMedics, Inc. Dr Fujioka reported receiving personal fees from EnteroMedics for help and consulting with European device approval. Dr Swain reports personal fees from surgical proctoring for Enteromedics. Dr Knudson reported that he is the chief executive officer of EnteroMedics and codeveloped the patented vagal nerve blockade device, which is owned by EnteroMedics. Dr Tweden reported that she is an employee of EnteroMedics and codeveloped the patented vagal nerve blockade device, which is owned by EnteroMedics. Dr Sarr reported that he is a consultant for EnteroMedics. Dr Billington reported that he is a consultant for EnteroMedics and NovoNordisk and has received pgrant support from Covidien.
Funding/Support: The ReCharge Study was supported by EnteroMedics Inc, St Paul, Minnesota.
Role of the Funder/Sponsor: EnteroMedics Inc was involved in the design and conduct of the study, site selection, database management. The sponsor provided funding to the clinical sites for patient enrollment, core laboratory analyses, clinical events adjudications, and database entry. The sponsor provided fees to North American Science Associates for independent statistical analyses. Two sponsor representatives (Knudson and Tweden) were allowed to review and participate in the critical revision of the manuscript prior to submission.
National Primary Investigators: Michael G. Sarr, MD, and Charles J. Billington, MD.
Study and Weight Management Coordinators: University of Minnesota: Bridget Slusarek, Elsie Waddick, Shannon Johnson, and Nikolaus Rasmus; Scottsdale Bariatric Center: Melisa Celaya, Heather Lane, Samantha Easterly, Cassie Truran, Arrin Larson, Dorrie Wilson, Katherine Emershad, Jennifer Childress, and Angelia Seitz; Institute of Weight Control, Sydney: Radhika Butala, Gretel Young, Ruth Hutchinson, Kerry McCurley, and Geane Sharman; Adelaide Bariatric Centre, Adelaide: Jane Collins and Fiona McDonald; Tufts Medical Center: Ann Marie Melanson, Meghan Ariagno, Danielle DeMarco, and Jillian Regan; OHSU: Wencesly Paez, Chad Sorenson, Shannon Rentz, Gloria Scalzo, and Tracy Severson; Scripps Clinic: Jennifer Wagner, Mary Collard, Sandy Grad, Cindy Galm, and Melissa Susak; VCU: Donna Neatrour, Jill Meador, Sakita Sistrun, Melanie Wiggins, Carly Sopko, and Leah Loomis; Mayo Clinic: Amy Reynolds, Joe Hockert, Sue Starkson, Margaret Gall, and Debbie Dixon; and Stanford: Dana Schroeder and Kristine Birge.
Data and Safety Monitoring Board and Clinical Events Committee Members: James Freston, MD, (chair) Department of Medicine, University of Connecticut School of Medicine, Farmington; Daniel Bessesen, MD, Division of Endocrinology, University of Colorado Denver, Denver; Miguel Herrera, MD, Division of General Surgery, Universidad Nacional Autónoma de México at Instituto Nacional de la Nutrición Salvador Zubirán, Mexico City; Melissa Martinson, PhD, Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis; Frank Moody, MD, Department of Surgery, University of Texas Health Science Center, San Antonio.
Correction: This arricle was corrected on December 2, 2014, for incorrect reasons for device removal.