Lugtenberg, Rieneke T.
van den Hurk, Corina J. G.
Smorenburg, Carolien H.
Mosch, Linda
Houtsma, Danny
Deursen, Margaret A. G. den Hollander-van
Kaptein, Ad A.
Gelderblom, Hans
Kroep, Judith R.
Article History
Received: 11 March 2022
Accepted: 22 April 2022
First Online: 2 May 2022
Declarations
:
: This study was conducted in accordance with the protocol, the ethical principles laid down in the Declaration of Helsinki, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice (ICH GCP), guidelines and applicable regulatory requirements. The protocol, ICF, any other materials provided to the patients, and further requested information were submitted to the IEC/IRB and the competent authority. The regulatory application or submission for regulatory approval was made by the sponsor or designee as required by national law. The competent authority and the IEC/IRB were notified of the end of the study in accordance with local regulations.
: Informed consent was obtained from all individual participants included in the study.
: All authors read and approved the final manuscript.
: The authors declare no competing interests.