Mertens, Joachim C. http://orcid.org/0000-0002-1796-942X
Blanc-Guillemaud, Vanessa http://orcid.org/0000-0003-4471-178X
Claesen, Karen http://orcid.org/0000-0001-7414-6385
Cardona, Pere http://orcid.org/0000-0002-5849-1258
Hendriks, Dirk http://orcid.org/0000-0003-0884-4833
Tyl, Benoit http://orcid.org/0000-0001-5297-8412
Molina, Carlos A. http://orcid.org/0000-0003-0566-9945
Article History
Received: 25 June 2021
Revised: 19 October 2021
Accepted: 27 October 2021
First Online: 19 November 2021
Declarations
:
: The study was conducted according to the Declaration of Helsinki revised in Fortaleza and followed the Good Clinical Practices. Ethical approval was obtained from the respective ethics committees of the different centers and the study was approved by the competent authorities.
: All patients or their legal representatives gave their informed consent before participating in the trial.
: Not applicable.
: VBG and BT are employees of IRIS. DH received consultant honoraria from IRIS.