Breithaupt, Mareile H.
Krohmer, Evelyn
Taylor, Lenka
Koerner, Eva
Hoppe-Tichy, Torsten
Burhenne, Juergen http://orcid.org/0000-0002-2190-1698
Foerster, Kathrin I.
Dachtler, Markus
Huber, Gerald
Venkatesh, Rakesh
Eggenreich, Karin
Czock, David http://orcid.org/0000-0003-1217-5134
Mikus, Gerd http://orcid.org/0000-0003-1783-133X
Blank, Antje
Haefeli, Walter E. http://orcid.org/0000-0003-0672-6876
Funding for this research was provided by:
Medizinische Fakultät Heidelberg der Universität Heidelberg
Article History
Received: 9 September 2022
Accepted: 12 October 2022
First Online: 18 October 2022
Declarations
:
: The trial was conducted at a single center (KliPS) at the Heidelberg University Hospital, Germany. The study protocol was approved by the responsible Ethics Committee of the Medical Faculty of Heidelberg University (AFmo-012/2021) and the German competent authority (EudraCT 2020–003984-24, August 10, 2020). The trial was performed in accordance with Good Clinical Practice, the 1964 Declaration of Helsinki and its later amendments, and all pertinent legal requirements of Germany.
: Informed consent was obtained from all individual participants prior to inclusion in the study.
: IMP manufacturing was conducted and financed by Gen-Plus GmbH (MD, RV, and KE) and printed on a 2D Flexdose printer manufactured by DiHeSys (GH). Data analysis and interpretation were not influenced by the involvement of Gen-Plus GmbH. All other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript.