Author Contributions: Drs Dixon and Bailey had full access to all the data in the study and take responsibility for the integrity and the accuracy of the data analysis.
Study concept and design: Dixon, Schachter, O’Brien, Naughton.
Acquisition of data: Dixon, Schachter, O’Brien, Jones, Grima, Brown, Naughton.
Analysis and interpretation of data: Dixon, Schachter, O’Brien, Jones, Grima, Lambert, Brown, Bailey, Naughton.
Drafting of the manuscript: Dixon, Schachter, O’Brien, Jones, Grima, Bailey, Naughton.
Critical revision of the manuscript for important intellectual content: Dixon, Schachter, O’Brien, Jones, Grima, Lambert, Brown, Bailey, Naughton.
Statistical analysis: Dixon, Bailey, Naughton.
Obtained funding: Dixon, O’Brien, Naughton.
Administrative, technical, or material support: Dixon, Schachter, O’Brien, Jones, Grima, Lambert, Brown.
Study supervision: Dixon, O’Brien, Jones, Grima, Lambert, Naughton.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Dixon reported being supported by a National Health and Medical Research Council Senior Research Fellowship; his laboratory receives competitive research grant funding from Allergan Inc; serving as a consultant for Allergan Inc, Bariatric Advantage, and Scientific Intake; being a member of the Optifast medical advisory board for Nestle Health Australia; serving on the speakers bureaus for Eli Lilly and iNova Pharmaceuticals; developing educational material for Novartis and iNova Pharmaceuticals; and receiving travel assistance from GI Dynamics for an educational meeting. Dr Schachter reported being the medical director of Sleep Services Australia, which uses continuous positive airway pressure machines and masks from Resmed Australia, Fisher and Paykel New Zealand, and Phillips Respironics United States. Dr O’Brien reported receiving compensation as the national medical director for the American Institute of Gastric Banding since 2007; receiving compensation as the author of The Lap-Band Solution: A Partnership for Weight Loss ; serving as the emeritus director of the Centre for Obesity Research and Education (CORE), which receives a grant from Applied Medical toward educational programs; and receiving a grant from Allergan Inc for investigator-initiated research. Dr Lambert reported being supported by an National Health and Medical Research Council Senior Research Fellowship; his laboratory currently receives commercial research grant funding from Medtronic (formerly ARDIAN Inc), Servier Australia, Abbott (formerly Solvay), and Allergan Inc; serving as a consultant to Medtronic; and receiving honoraria or travel support for presentations from Pfizer, Wyeth Pharmaceuticals, Servier, and Medtronic. Dr Brown reported receiving an honorarium from Allergan Inc for attending a scientific advisory panel in London in 2009; serving as the director of CORE, which receives a grant from Allergan Inc for research support but the grant is not tied to any specified research projects and Allergan has no control of the protocol, analysis, and reporting of any studies; and that CORE receives a grant from Applied Medical toward educational programs. Dr Naughton reported being a recipient of competitive funding from Resmed and Respironics to assist in investigator-directed research; serving on the Australian Medical advisory boards of ResMed, Respironics, Covidian and Fisher, and Paykel; but that he and his family hold no stock or have any financial interest in any company related to sleep apnea or obesity. Drs Jones and Bailey and Ms Grima did not report any disclosures.
Funding/Support: The study was funded by the National Health and Medical Research Council of Australia project grant 436728 awarded to Monash University and the Baker IDI Heart and Diabetes Institute. The continuous positive airway pressure (CPAP) pumps were provided for all study participants by ResMed Australia, Fisher and Paykel New Zealand, and Phillips Respironics United States. The laparoscopic adjustable gastric bands (Allergan Health) and the laparoscopic ports (Applied Medical) were provided without charge by the manufacturers. The Avenue Hospital subsidized the hospitalization costs for the surgical study participants.
Role of the Sponsors: The funding sponsors played no part in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Sponsors had no access to the data and did not perform any of the study analysis.
Additional Contributions: We thank Julie Playfair, BNurs (Centre for Obesity Research and Education, Monash University), and Julie Nguyen, BBiomedSc(Hons), and Tony Xu, BBiomedSc(Hons) (both with the Obesity Research Unit, Department of General Practice, Monash University), for their contributions when employed as research assistants on the project. We also thank Frank Thien, MD, Alan Young, MBBS, PhD, and Paul Fogarty, MBBS (Respiratory and Sleep Medicine, Box Hill Hospital), Simon Frenkel, MBBS (Department of Sleep Disorders and Respiratory Medicine, Footscray Hospital), Jeremy Goldin, MBBS (Respiratory and Sleep Disorders, Royal Melbourne Hospital), Garun Hamilton, MBBS, PhD, and Xun Li, MD (both with Respiratory and Sleep Medicine, Monash Medical Centre), Andrew Kyoong, MBBS (Respiratory Medicine, St Vincent's Hospital), Marcus McMahon, MBBS, and Fergal O’Donoghue, MBBS (both with the Respiratory and Sleep Disorders, Austin Hospital), Belinda Miller, MBBS (Hons), PhD (Allergy, Immunology and Respiratory Medicine, Alfred Hospital), and Chris Steinfort, MBBS (Respiratory and Sleep Medicine, Barwon Health) for inviting their patients to participate. We also thank the following sleep laboratories in which patients were studied: Alfred Hospital, Austin Hospital, Cabrini Hospital, Epworth Hospital, Monash Medical Centre, Royal Melbourne Hospital and St Vincent's Hospital. We acknowledge Stewart Skinner, MBBS (Hons), PhD (Department of Surgery, Monash University), and Vikas Wadhwa, MBBS (Respiratory and Sleep Medicine, Maroondah Hospital), for their clinical expertise in caring for study participants. Only the research assistants employed on the project received compensation.