GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

"Guarantor of the article: Byron Cryer, MD.: Specific author contributions: B.C., L.S.S., G.S., and M.J.S. constituted the Executive Committee overseeing the study. M.F.B. designed the study with contributions from the other authors. C.L. performed the statistical analysis, and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors participated in drafting and revising the manuscript.: Financial support: This study was sponsored by Pfizer. Editorial support was provided by William Watkins, of PAREXEL, and was funded by Pfizer.: Potential competing interests: Byron Cryer has served as a consultant for Pfizer, Astra-Zeneca, PLx Pharma, McNeil Consumer Products, and Ritter Pharmaceuticals, and has received consulting fees, honorarium, and travel support from Pfizer. Chunming Li and Manuela Berger are full-time employees of Pfizer and own stocks and shares in Pfizer. Lee S. Simon has served as a consultant for Pfizer, Astra-Zeneca, PLx Pharma, Logical Therapeutics, Bayer Healthcare, Horizon Pharmaceuticals, Takeda, and Posen, and has received consulting fees and travel support from these companies. Gurkirpal Singh has received consulting fees and honorarium from Pfizer and has received grants from Pfizer, Novartis, Pozen, and Astra-Zeneca. Martin Stillman has served as a consultant for Pfizer, Alpharma, and NicOx S.A., and has received consulting fees and honorarium from Pfizer."

"Financial support: This study was sponsored by Pfizer. Editorial support was provided by William Watkins, of PAREXEL, and was funded by Pfizer."

"We thank Dr Ha Nguyen (Pfizer) for many helpful and insightful comments on the manuscript. This trial was registered withclinicaltrials.gov identifier: NCT00373685."