Accepted for Publication: February 17, 2018.
Corresponding Author: Kristine Steffen, PharmD, PhD, Pharmaceutical Sciences, North Dakota State University, Department 2665, PO Box 6050, Fargo, ND 58108-6050 (kristine.steffen@ndsu.edu).
Published Online: February 20, 2019. doi:10.1001/jamasurg.2018.1162
Author Contributions: Drs King and White had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Steffen, Subak, Mitchell, Flum, Huang.
Acquisition, analysis, or interpretation of data: Steffen, White, Subak, Mitchell, Courcoulas, Flum, Strain, Sarwer, Kolotkin, Pories, Huang.
Drafting of the manuscript: Steffen, White, Flum, Huang.
Critical revision of the manuscript for important intellectual content: Steffen, White, Subak, Mitchell, Courcoulas, Flum, Strain, Sarwer, Kolotkin, Pories, Huang.
Statistical analysis: White.
Obtained funding: Subak, Mitchell, Flum.
Administrative, technical, or material support: Subak, Courcoulas, Flum, Kolotkin, Pories.
Supervision: Sarwer, Huang.
Conflict of Interest Disclosures: Dr Steffen reports having received grant funds from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Alcohol Abuse and Alcoholism, Shire Pharmaceuticals, and Sanford Profile North Dakota State University. Dr Coucourlas reports having received research grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Patient-Centered Outcomes Research Institute. Dr Subak reports having received a research grant from Astellas. Dr Sarwer reports acting as a consultant for BAROnova, Ethicon, Medtronic, and Novo Nordisk and receiving a grant from the National Institute for Diabetes and Digestive and Kidney Disease (grant R01-DK108628-01). Dr Kolotkin reports receiving royalties from Duke University for the development of the Impact of Weight on Quality of Life–Lite. Dr Huang has received funding from Pfizer Inc via contracts with the University of California San Francisco to conduct research unrelated to bariatric surgery or urinary incontinence. No other disclosures were reported.
Funding/Support: LABS-2 was funded by a cooperative agreement by the National Institute of Diabetes and Digestive and Kidney Diseases (grants U01 DK066557 [Data Coordinating Center], U01-DK66667 [Columbia-Presbyterian], UL1-RR024996 [Columbia-Presbyterian in collaboration with Cornell University Medical Center Clinical and Translational Science Center], U01-DK66568 [University of Washington], M01RR-00037 [University of Washington in collaboration with the Clinical and Translational Research Center], U01-DK66471 [Neuropsychiatric Research Institute], U01-DK66526 [East Carolina University], U01-DK66585 [University of Pittsburgh Medical Center], UL1-RR024153 [University of Pittsburgh Medical Center in collaboration with the Clinical and Translational Research Center]), and U01-DK66555 [Oregon Health & Science University]).
Role of the Funder/Sponsor: Scientists from the National Institute of Diabetes and Digestive and Kidney Diseases contributed to the design and conduct of the study, which included collection and management of data. The project scientist from the Diabetes and Digestive and Kidney Diseases served as a member of the steering committee, along with the principal investigator from each clinical site and the data coordinating center. The data coordinating center housed all data during the study and performed data analyses according to a pre-specified plan developed by the data coordinating center biostatistician and approved by the steering committee and independent data and safety monitoring board. The decision to publish was made by the Longitudinal Assessment of Bariatric Surgery-2 steering committee, with no restrictions imposed by the sponsor.
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