Bruse, Niklas
Pardali, Katerina
Kraan, Maarten
Kox, Matthijs
Pickkers, Peter
,
Funding for this research was provided by:
AM-Pharma B.V.
Article History
Received: 22 November 2023
Accepted: 12 February 2024
First Online: 19 February 2024
Declarations
:
: This trial was conducted in accordance with the protocol and consensus ethical principles of international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. The protocol, the single substantial protocol amendment and other relevant documents were reviewed and approved by the Institutional Research Board (IRB)/Institutional Ethics Committee (IEC) in the relevant centers prior to being used in the trial.
: Informed consent was obtained from all patients or the patient’s legal representative.
: Please see Additional file InternalRef removed for competing interests of the steering committee. The other authors have nothing to disclose.