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Article History

Received: 8 July 2024

Accepted: 24 September 2024

First Online: 9 November 2024

Declarations

:

: Nick H Kim served as a Scientific Committee member for Johnson & Johnson; received research grants/support from Enzyvant and Lung Biotechnology; received consultant fees from Johnson & Johnson, Bayer, Merck, United Therapeutics, Gossamer Bio, Pulnovo and Polarean; and received speaker fees from Johnson & Johnson, Bayer and Merck. Andrea M D'Armini has received fees for organising Masters-level courses, lecture fees and writing assistance from Merck and AOP health; and fees for serving on Scientific Committees from Johnson & Johnson. Luke S Howard has received consultancy fees from Ferrer, Johnson & Johnson and Morphic; fees for serving on Scientific Committees/advisory boards from Gossamer Bio, Apollo Therapeutics, Altavant, MSD and Johnson & Johnson; honoraria for lectures from Johnson & Johnson, MSD, Aerovate and Ferrer; fees for expert testimony from Johnson & Johnson; travel support from Johnson & Johnson and Gossamer Bio; received institutional grant support from MSD and holds stock in Circular, ATXA Therapeutics, iOWNA, Calibre Biometrics and OneWelbeck Clinic. David P Jenkins has received fees for serving on a Scientific Committee for Johnson & Johnson and lecture fees from Bayer. Zhi-Cheng Jing has received consultancy fees, lecture fees and fees for serving on a Scientific Committee from Johnson & Johnson, Bayer, GlaxoSmithKline, Lee’s Pharmaceuticals, and Pfizer; fees for serving on an adjudication committee from Johnson & Johnson; and grant support from Johnson & Johnson, Bayer, GlaxoSmithKline, Pfizer, The National Science Fund for Distinguished Young Scholars (81425002), CAMS Innovation Fund for Medical Sciences (2016-I2M-1–002), and The National Key Research and Development Program of China (No. 2016YFC0901502). Current affiliation: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. Eckhard Mayer has received consultancy fees from Johnson & Johnson, Bayer and Merck; lecture fees from Johnson & Johnson, Bayer and Merck; and fees for serving on a Scientific Committee for Johnson & Johnson. Liliya Chamitava, was an employee of Johnson & Johnson at the time of the study. Current affiliation: Valos S.r.L, Genova, Italy. Gabriela Lack, Hany Rofael and Maria Solonets are employees of Johnson & Johnson. Hossein-Ardeschir Ghofrani has received fees for serving as a board member for AbbVie, Bellerophon Pulse Technologies, Medscape, OMT, UCB Celltech, and Web MD Global; consultancy fees and fees for serving on a Scientific Committee for Johnson & Johnson, Bayer, Gilead Sciences, GlaxoSmithKline, Merck, Novartis, and Pfizer; lecture fees from Johnson & Johnson, Bayer, GlaxoSmithKline, Merck, Novartis, and Pfizer; and grant support from Johnson & Johnson, Bayer, Novartis, and Pfizer.

: Data were collected in MERIT-1 and MERIT-2 in accordance with the Good Clinical Practice guidelines and Declaration of Helsinki. The study protocol was approved by the institutional review board, or independent ethics committee at each participating site and patients gave full written consent for their participation and use of their data for publication. The Scientific Committee, composed of external experts in CTEPH with experience in clinical studies, were involved in the study design and provided guidance on both MERIT-1 and MERIT-2. An Independent Liver Safety Data Review Board provided assessment and advice regarding serious hepatic adverse events of special interest (AESI). The list of study sites, investigators and ethical committees are included in Supplementary Methods 1.