Document is current
Any future updates will be listed below
-
Authors
Osteen, Jeremiah D.
Immani, Swapna
Tapley, Tim L.
Indersmitten, Tim
Hurst, Nicole W.
Healey, Tiffany
Aertgeerts, Kathleen
Negulescu, Paul A.
Lechner, Sandra M.
-
Funding
Funding for this research was provided by:
Vertex Pharmaceuticals
- License Information
-
More Information
Article History
Received: 8 October 2024
Accepted: 4 December 2024
First Online: 8 January 2025
Declarations
:
: All authors (Jeremiah D. Osteen, Swapna Immani, Tim L. Tapley, Tim Indersmitten, Nicole W. Hurst, Tiffany Healey, Kathleen Aertgeerts, Paul A. Negulescu, Sandra M. Lechner) are employees of Vertex Pharmaceuticals and own stock and/or options in the company.
: Animal studies were conducted in Sprague Dawley (CD®[Crl:CD®(SD)]) rats and cynomolgus monkeys. Animals were sourced from Charles River Laboratories (USA). Each study in animals was approved by the laboratory’s Institutional Animal Care and Use Committee (IACUC). Animal care conformed to applicable national/international guidelines and the studies were conducted in accordance with Good Laboratory Practice (GLP). The clinical trial protocols were approved by a central institutional review board (Advarra Institutional Review Board, Columbia, MD, USA) and all sites accepted this central approval. The trials were conducted according to the International Council for Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. All participants provided written informed consent.
