Document is current
Any future updates will be listed below
-
Authors
Raman, Sudha R.
Hammill, Bradley G.
Shaw, Pamela A.
Lee, Hana
Toh, Sengwee
Connolly, John G.
Dandreo, Kimberly J.
Nalawade, Vinit
Tian, Fang
Liu, Wei
Li, Jie
Hernández-Muñoz, José J.
Glynn, Robert J.
Desai, Rishi J.
Weberpals, Janick
-
Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037, Master Agreement 75F40119D10037)
- License Information
-
More Information
Article History
Received: 7 March 2024
Accepted: 5 September 2024
First Online: 19 October 2024
Declarations
:
: This study was deemed to not meet the definition of research by the Duke University Health System Institutional Review Board.
: This study was deemed to not meet the definition of research by the Duke University Health System Institutional Review Board.
: The US Food and Drug Administration (FDA) approved the study protocol, statistical analysis plan and reviewed and approved this manuscript. Coauthors from the FDA participated in the results interpretation and in the preparation and decision to submit the manuscript for publication. The FDA had no role in data collection, management, or analysis. Janick Weberpals reports prior employment by Hoffmann-La Roche and previously held shares in Hoffmann-La Roche. Pamela Shaw is a named inventor on a patent licensed to Novartis by the University of Pennsylvania for an unrelated project. Sengwee Toh serves as a consultant for Pfizer, Inc. and TriNetX, LLC. on unrelated projects. Robert J Glynn has received research funding through his employer from Amarin, Kowa, Novartis, and Pfizer. Dr. Desai reports serving as Principal Investigator on investigator-initiated grants to the Brigham and Women’s Hospital from Novartis, Vertex, and Bristol-Myers-Squibb on unrelated projects. All remaining authors report no disclosures or conflicts of interest.
