Document is current

Article History

Accepted: 21 July 2023

First Online: 4 August 2023

Declarations

:

: LD, TH, and REM are employees and shareholders of Eli Lilly and Company which provided financial support for this study. LS and GH are employees of Evidera, who performed this research. JDL consulted or served on an advisory board for Eli Lilly and company, Samsung Bioepis, UCB, Bristol-Myers Squibb, Nestle Health Science, Merck, Celgene, Janssen Pharmaceuticals, Bridge Biotherapeutics, Entasis Therapeutics, AbbVie, Pfizer, Gilead, Arena Pharmaceuticals, Protagonist Therapeutics, Amgen, and Scipher Medicine. JDL has had research funding from Nestle Health Science, Takeda, Janssen Pharmaceuticals, and AbbVie. JDL has performed legal work on behalf of generic manufacturers of ranitidine, including L. Perrigo Company, Glenmark Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Aurobindo Pharma USA, Inc., Dr. Reddy’s Laboratories, Inc., Novitium Pharma, Ranbaxy Inc. and Sun Pharmaceutical Industries, Inc., Strides Pharma, Inc., and Wockhardt USA LLC. JDL owns stock in Dark Canyon Labs. MCD has received consulting fees from AbbVie Inc, Arena Pharmaceuticals; Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Celgene Corporation; Eli Lilly and Company; F. Hoffmann-La Roche Ltd, Genentech, Inc, Gilead; Janssen Global Services, LLC; Pfizer Inc, Prometheus Biosciences, Takeda Pharmaceuticals USA, Inc, and UCB SA, and research funding from AbbVie Inc, Janssen Global Services, LLC, Pfizer Inc, and Prometheus Biosciences, and received licensing fees from Takeda Pharmaceuticals USA, Inc. MCD owns stock in Trellus Health Inc.

: This study was conducted in compliance with Good Clinical Practice guidelines, including International Conference on Harmonization Guidelines. In addition, all applicable local laws and regulatory requirements were adhered to throughout the study. Before recruiting participants, all study documents were submitted and approved by the Advarra IRB.

: Informed consent was obtained from all individual participants included in the study.

: All patients and clinicians who participated in this study provided consent for publication of their information and responses.