Author Contributions: Drs Cotton and Durkalski had full access to all of the data in the study, and take responsibility for the integrity of the data and the accuracy of the data analysis.
Acquisition, analysis, or interpretation of data: Cotton, Durkalski, Romagnuolo, Pauls, Fogel, Tarnasky, Aliperti, Freeman, Kozarek, Jamidar, Wilcox, Serrano, Brawman-Mintzer, Elta, Mauldin, Thornhill, Wood-Williams, Orrell, Drossman, Robuck.
Drafting of the manuscript: Cotton, Durkalski, Brawman-Mintzer, Drossman.
Critical revision of the manuscript for important intellectual content: Cotton, Durkalski, Romagnuolo, Pauls, Fogel, Tarnasky, Aliperti, Freeman, Kozarek, Jamidar, Wilcox, Serrano, Brawman-Mintzer, Elta, Mauldin, Hawes, Orrell, Drossman, Thornhill, Wood-Williams, Robuck.
Statistical analysis: Cotton, Durkalski, Pauls.
Obtained funding: Cotton, Durkalski, Serrano, Robuck.
Administrative, technical, or material support: Durkalski, Serrano, Thornhill, Wood-Williams, Orrell, Robuck.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Cotton reported that he has received a gift of endoscopic accessories (sphincterotomes) from Cook Medical to be used in the study, to prevent patients being unblinded by getting a bill, consults for Olympus America, and receives royalties from Cook Medical for devices not used in the study. Dr Romagnuolo reported that he consults and receives lecture fees from Olympus and Cook Medical. Dr Fogel reported that he consults for Cook Endoscopy and Boston Scientific and receives lecture fees from Olympus. Dr Tarnasky reported that he consults for and has received lecture fees from Boston Scientific. Dr Aliperti reported that he receives lecture fees from Oklahoma Endoscopy Society. Dr Freeman reported that he has had research grants from Boston Scientific and Cook Endoscopy. Dr Jamidar reported that he consults for Boston Scientific and receives lecture fees from Olympus and Boston Scientific. Drs Serrano reported that he was an employee of NIDDK during key parts of the study. Dr Elta reported that she consults for Olympus. Drs Drossman and Elta reported that they were compensated from the EPISOD grant as consultants. Dr Robuck reported that she was an employee of NIDDK during the key parts of the study and is now retired. All of the others authors had some effort funded by the grant from NIDDK to perform this study and were reimbursed for expenses involved in traveling to investigator meetings. No other disclosures are reported.
Funding/Support: This study was funded by grant U01 DK074739 from the National Institutes of Diabetes and Digestive and Kidney Diseases.
Role of the Sponsors: The study was funded by NIDDK as a cooperative agreement. The NIDDK staff participated in the design of the study and monitored its progress with a steering committee and DSMB. The investigators were responsible for all elements of the trial including design, data collection, and analysis. The study was monitored by an independent DSMB appointed by NIDDK.
Previous Presentation: The primary results of the EPISOD study were presented briefly at the annual meeting of the American College of Gastroenterology in October 2013, but not published because it was a “late-breaking” abstract submitted after the journal went to press.