Accepted for Publication: October 3, 2012.
Published Online: February 4, 2013. doi:10.1001/jamapediatrics.2013.1045
Author Contributions: Dr Kelly had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Kelly, Nathan, Fox, Metzig, Fitch, and Abuzzahab. Acquisition of data: Kelly, Nathan, Metzig, Fitch, and Abuzzahab. Analysis and interpretation of data: Kelly, Rudser, Nathan, Fox, Coombes, Bomberg, and Abuzzahab. Drafting of the manuscript: Kelly, Rudser, Fox, and Metzig. Critical revision of the manuscript for important intellectual content: Kelly, Rudser, Nathan, Fox, Metzig, Coombes, Fitch, Bomberg, and Abuzzahab. Statistical analysis: Kelly, Rudser, and Coombes. Obtained funding: Kelly. Administrative, technical, and material support: Kelly, Fox, Metzig, Bomberg, and Abuzzahab. Study supervision: Kelly, Nathan, and Fitch.
Conflict of Interest Disclosures: Dr Kelly has received research funding from Amylin and Eli Lilly and served on a pediatric obesity advisory board (clinical trial design) for Novo Nordisk. Dr Abuzzahab receives research funding from Amylin and Eli Lilly.
Funding/Support: Funding for this study was provided by a Community Health Collaborative grant from the University of Minnesota Clinical and Translational Science Institute, by award 1UL1RR033183 from the National Center for Research Resources, and by grant 8UL1TR000114-02 from the National Center for Advancing Translational Sciences of the National Institutes of Health.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources, the National Center for Advancing Translational Sciences, or the National Institutes of Health
Additional Contributions: We thank Amylin for generously providing the study drug and placebo. We thank the patients and their families for donating their time to make this study possible. We also than Betsy Schwartz, MD (Park Nicollet, St Louis Park, Minnesota), for providing independent oversight for data and safety monitoring, Charles Billington, MD (University of Minnesota), for consulting on study design and conduct issues, and Mary Deering, RN (University of Minnesota), for providing nursing support.