Accepted for Publication: March 13, 2020.
Published Online: June 17, 2020. doi:10.1001/jamasurg.2020.1501
Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2020 Lee SH et al. JAMA Surgery.
Corresponding Author: Do Joong Park, MD, PhD, Department of Surgery and Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea (djparkmd@snu.ac.kr).
Author Contributions: Dr D. J. Park had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: S. H. Lee, Jang, Yoo, Ryu, Y.S. Park, D. J. Park.
Acquisition, analysis, or interpretation of data: S. H. Lee, Jang, Yoo, Hwang, Ryu, Kwon, Hur, Yoon, Eom, H. S. Ahn, Son, Song, H. H. Lee, Choi, An, S.-I. Lee, K. H. Lee, S. Ahn, D. J. Park.
Drafting of the manuscript: S. H. Lee, Jang, Ryu, D. J. Park.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: S. H. Lee, H. S. Ahn, K. H. Lee, S. Ahn, D. J. Park.
Obtained funding: S. H. Lee, Ryu, D. J. Park.
Administrative, technical, or material support: S. H. Lee, Jang, Yoo, Ryu, Eom, H. S. Ahn, An, K. H. Lee, Y. S. Park, D. J. Park.
Supervision: S. H. Lee, Ryu, Song, An, D. J. Park.
Conflict of Interest Disclosures: Dr S.H. Lee reported receiving speaker honoraria and grants from Daewoong Pharmaceutical Co Ltd during the conduct of the study. Dr Yoo reported receiving grants from Daewoong Pharmaceutical Co Ltd during the conduct of the study. Dr Y. S. Park reported receiving grants from Daewoong Pharmaceutical Co Ltd during the conduct of the study. Dr D. J. Park reported receiving speaker honoraria from Daewoong Pharmaceutical Co Ltd during the conduct of the study; and a research grant from Medtronic outside the submitted work. No other disclosures were reported.
Funding/Support: This study was supported by a research grant from Daewoong Pharmaceutical Co Ltd.
Role of the Funder/Sponsor: The funding source, with guidance from the steering committee, was involved in the study design, data collection and analysis, and manuscript preparation process.
Group Information: The Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group members are Do Joong Park (principal investigator [PI]), Sang Hyub Lee (co-PI), Moon-Won Yoo, Sun-Hwi Hwang, Seong-Yeob Ryu, Oh Kyoung Kwon, Hoon Hur, Hong Man Yoon, Bang Wool Eom, Hye Seong Ahn, Taeil Son, Kyo Young Song, Han Hong Lee, Min-Gew Choi, Ji Yeong An, Sang-Il Lee (all site PIs), Dong Kee Jang, Kyung Ho Lee, Young Suk Park (all investigators), and Soyeon Ahn (principal biostatistician).
Meeting Presentation: This paper was presented at the Lecture Presentation of Research Forum of the Digestive Disease Week; May 18, 2019; San Diego, California; at the International Gastric Cancer Congress; May 10, 2019; Prague, Czech Republic; and at the 39th Congress of the European Society of Surgical Oncology; October 10, 2019; Rotterdam, the Netherlands.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the patients and their families for participating in the trial. Kyung Won Kim, MD, PhD, Asan Medical Center; Jee Hyun Baek, MD, Human Medical Imaging and Intervention Center; Hyun Sik Woo, MD, Boramae Medical Center; and Eun Sun Lee, MD, PhD, Chung-Ang University Hospital provided consultation regarding radiologic criteria. They were compensated for their contributions. Hyung-Ho Kim, MD, PhD, and Sang-Hoon Ahn, MD, Seoul National University Bundang Hospital; Beom-Su Kim, MD, PhD, and In Seob Lee, MD, PhD, Asan Medical Center; and Ji Yoen Park, MD, Kyoungpook National University Hospital were investigators for each institute. They were not compensated for their contributions. Hyun Ju Shin, BS, Daewoong Pharmaceutical Co Ltd, was clinical project leader and Bobae Jo, MS, Daewoong Pharmaceutical Co Ltd, was the statistician. They were not compensated for their contributions.
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