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Article History

Received: 14 October 2022

Accepted: 6 April 2023

First Online: 16 May 2023

Declarations

:

: The trial was approved by the local regulatory authorities and the independent ethics committees covering all participating centres, and was performed in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, and local regulatory requirements. All participants provided written informed consent.

: Not applicable (no individual patient images or data included in this manuscript).

: M.F.S. has received grants and/or speaker fees from Ferring, Merck, Organon, MSD, Gedeon Richter, Theramex, IBSA. P.L. is an employee of Ferring Pharmaceuticals. M.F. has received consulting fees from Gedon Richter, speaker fees from Merck, MDS, Gedeon Richter and Ferring Pharmaceuticals, and has received support for attending meetings and/or travel from Ferring Pharmaceuticals, Merck, MSD, Gedeon Richter, IBSA, and Theramex. E.B. has received research funding from Roche Diagnostics and IBSA, a grant from Gedeon-Richter, speaker fees from Ferring Pharmaceticals, Merck, MSD, Gedeon-Richter, Roche Diagnostics and IBSA, and has participated in data safety monitoring/advisory board for Ferring Pharmaceuticals, Merck, MSD, Gedeon-Richter Roche Diagnostics, IBSA, and Abbott. J.A.G.V. has received grants and/or speaker fees from Ferring, Merck, Organon, MSD, Gedeon Richter, Theramex and IBSA. E.S.L. has no completing interests. B.M. was an employee of Ferring Pharmaceuticals at the time of the study.