Grünig, Ekkehard
Rahaghi, Franck
Elwing, Jean
Vizza, Carmine Dario
Pepke-Zaba, Joanna
Shen, Jieyan
Yao, Hua
Hage, Antoine
Rosenkranz, Stephan
Vonk, Madelon
Balasubramanian, Vijay
Yuanhua, Yang
Yu, Zaixin
Lordan, James
Cadaret, Linda
Grover, Rob
Ousmanou, Aliou
Seaman, Scott
Deng, Chunqin
Broderick, Meredith
White, R. James http://orcid.org/0000-0003-1399-5206
,
Funding for this research was provided by:
United Therapeutics Corporation
Article History
Received: 29 July 2023
Accepted: 9 October 2023
First Online: 6 December 2023
Declarations
:
: The following authors have declarations of support from organizations for the submitted work: Ekkehard Grünig, Franck Rahaghi, Jean Elwing, Carmine Dario Vizza, Joanna Pepke-Zaba, Jieyan Shen, Hua Yao, Antoine Hage, Stephan Rosenkranz, Madelon Vonk, Vijay Balasubramanian, Yang Yuanhua, Zaixin Yu, James Lordan, Linda Cadaret and R. James White received institutional funding from United Therapeutics in order to conduct the study at their respective institutions. Ekkehard Grünig, Franck Rahaghi, Jean Elwing, Carmine Dario Vizza, Joanna Pepke-Zaba, Stephan Rosenkranz, Madelon Vonk, Vijay Balasubramanian, and Linda Cadaret have received support for consultation, advisory and/or speaker bureau from United Therapeutics. Rob Grover, Aliou Ousmanou, Scott Seaman, Chunqin Deng, and Meredith Broderick are employees of United Therapeutics. Below, is a summary of each authors’ disclosures, related and unrelated to the submitted work. Ekkehard Grünig—Received fees for lectures and/or consultations from Actelion, Bayer/MSD, Ferrer, GEBRO, GSK, Janssen and OMT. Research grants to his institution have been received from Acceleron, Actelion, BayerHealthCare, MSD, Bellerophon, GossamerBio, GSK, Janssen, Novartis, OMT, Pfizer, REATE and United Therapeutics. Franck Rahaghi—received research support, serving on Advisory Board, Consultation and/or Speaker bureau for United Therapeutics; grants or contracts from Bayer, Janssen PH, and Acceleron. Jean Elwing—received grant/research support and/or serving on Advisory Boards for Janssen, United Therapeutics, Liquidia, Phase Bio, Gossamer Bio, Bayer, Acceleron/Merck, Altavant, Aerovate, Tenax, and Pharmosa. Carmine Dario Vizza—received grant/research support and/or serving on Advisory Boards or as a consultant for Ferrier, GSK, MSD, Bayer Actelion and United Therapeutics. Joanna Pepke-Zaba—received honoraria for lecturing and consulting from Bayer, Actelion, and GSK; on advisory boards for Actelion, Pfizer, Bayer, GSK, and United Therapeutics. Jieyan Shen—received institutional funding from United Therapeutics in order to conduct the study at their institution. Hua Yao—received institutional funding from United Therapeutics in order to conduct the study at their institution. Antoine Hage—received research grant/support from Actelion, Bayer, United Therapeutics, REATA and Arena. Stephan Rosenkranz—received research grants or contracts from Actelion, AstraZeneca, Bayer, Janssen, and Novartis; consulting fees from Abbott, Acceleron, Actelion, Bayer, Janssen, MSD, Novartis, Pfizer, United Therapeutics, and Vifor; and payment or honoraria from Actelion, Bayer, BMS, Ferrer, GSK, Janssen, MSD, Novartis, Pfizer, United Therapeutics, and Vifor. Madelon Vonk—Received research support, serving on Advisory Board, Consultation and/or Speaker bureau for Actelion, Boehringer Ingelheim, Ferrier, GSK, and Roche. Vijay Balasubramanian—received research support, serving on Advisory Board, Consultation and/or Speaker bureau for United Therapeutics, Bayer, and Boehringer Ingelheim. Yuanhua Yang—received institutional funding from United Therapeutics in order to conduct the study at their institution. Zaixin Yu—Received institutional funding from United Therapeutics in order to conduct the study at their institution. James Lordan—received institutional funding from United Therapeutics in order to conduct the study at their institution. Linda Cadaret—received grant/ research support and/or serving on Advisory Boards for United Therapeutics. Rob Grover—employee of the United Therapeutics—sponsor of the study. Aliou Ousmanou—employee of the United Therapeutics—sponsor of the study. Scott Seaman—employee of the United Therapeutics—sponsor of the study. Chunqin Deng—employee of the United Therapeutics—sponsor of the study. Meredith Broderick—employee of the United Therapeutics—sponsor of the study. R. James White—received research support (payment to institution only) from United Therapeutics.
: The protocol and all study-related documents were approved by the institutional review board or independent ethics committee for each site. The full list of institutional review board and independent ethic committee names, locations, and serial numbers can be found in the Supplementary Materials. The study was conducted in accordance with the tenets of the Declaration of Helsinki and Good Clinical Practice. Written informed consent was obtained from all participants.