Ivy, Dunbar
Beghetti, Maurice
Juaneda-Simian, Ernesto
Ravindranath, Ramiya
Lukas, Mary Ann http://orcid.org/0000-0003-0791-5580
Machlitt-Northen, Sandra
Scott, Nicola
Narita, Jun
Berger, Rolf M. F.
Article History
Received: 8 September 2023
Revised: 8 January 2024
Accepted: 21 January 2024
First Online: 16 February 2024
Declarations
:
: The study was conducted according to the ethical principles of the Declaration of Helsinki, the International Council on Harmonisation of technical requirements for pharmaceuticals for human use – Good Clinical Practice (ICH-GCP) guidelines, and all applicable local regulatory requirements. The protocol was pre-approved by relevant national, regional, or investigational center ethics committees or institutional review boards.
: Written informed consent was obtained from all participants or their parents, as applicable.
: The University of Colorado contracts with GSK, Bayer, Janssen and Merck for DI to be a consultant. MB reports remunerations for lectures and/or consultancy from Actelion/Janssen, Acceleron/Merck, AOP, Bayer, Gossamer, Altavant, Eli Lilly and Company, Occlutech, GSK, and MSD. EJ-S has received funding from GSK. RR, MAL, SM-N, and NS are employees of GSK and hold stock and shares in GSK Group of Companies. JN has no disclosures to report. RMFB has participated in advisory boards and steering committees for GSK, Ely Lilly, MSD, and Janssen through the University Medical Center Groningen.