de Boer, S. E.
Sanders, J. S.F.
Bemelman, F. J.
Betjes, M. G.H.
Burgerhof, J. G.M.
Hilbrands, L.
Kuypers, D.
van Munster, B. C.
Nurmohamed, S. A.
de Vries, A. P.J.
van Zuilen, A. D.
Hesselink, D. A.
Berger, S. P.
Funding for this research was provided by:
ZonMw (848042001)
Chiesi Farmaceutici (NA)
Novartis Pharma (NA)
Article History
Received: 9 April 2021
Accepted: 18 May 2021
First Online: 2 June 2021
Declarations
:
: The trial was designed and will be implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki, Brazil, October 2013. The trial has been approved by the Medical Research Ethical Committee of the University Medical Centre Groningen (2018.698). Written informed consent is obtained from all patients by study personnel prior to any study assessment. Consent for the storage and future use of body materials up to 15 years after the end of the trial is an optional part of the informed consent.
: Not applicable.
: LBH has received consulting fees from Chiesi and grant support from Chiesi and Sandoz (paid to Radboudumc).APJdV has received consulting fees from Chiesi and Sandoz and grant support from Chiesi and Sandoz (paid to LUMC).DAH has received lecture and consulting fees from Astellas Pharma and Chiesi Pharma, as well as grant support from Astellas Pharma and Chiesi Pharma (paid to Erasmus MC).SPB has received lecture and consulting fees from Novartis (paid to UMCG) and grant support from Novartis and Chiesi.