Ghadimi, Michael
Pelzer, Uwe
Besselink, Marc G.
Siveke, Jens
Telgmann, Ralph
Braren, Rickmer
Wilmink, Hanneke
Crede, Marie
Koenig, Alexander
Koenig, Ute
Liffers, Sven Thorsten
Antweiler, Kai
Uijterwijk, Bas
Seppanen, Hanna
Nordin, Arno
Puolakkainen, Pauli
Dajani, Olav F.
Labori, Knut Jørgen
Johansson, Mia
Bratlie, Svein Olav
Friede, Tim
Jo, Peter
Funding for this research was provided by:
Herzzentrum Göttingen
Article History
Received: 12 January 2025
Accepted: 21 January 2025
First Online: 6 February 2025
Declarations
:
: METAPANC is a phase III clinical trial implemented and reported in accordance with the CTR (EU) 536/2014, ICH-GCP, with applicable member states regulations, and with the ethical principles laid down in the Declaration of Helsinki. It was submitted, evaluated, and approved via CTIS with Germany as the reporting member state. A statement of ethical approval and consent was issued by the State Office for Health and Social Affairs (LAGESO) Berlin, Germany. The ethic committee of the federal state of Berlin approved the study. METAPANC is registered under its EU Clinical Trial Number 2023-503558-10-00 in the EU Clinical Trial Register.
: Not applicable
: TF declares personal fees for statistical consultancies (including data monitoring committees) from Actimed, Apellis, Aslan, AstraZeneca, Bayer, BiosenseWebster, BMS, Cardior, CSL Behring, Daiichi Sankyo, Enanta, Fresenius Kabi, Galapagos, IQVIA, Immunic, KyowaKirin, LivaNova, Minoryx, Novartis, PINK! gegen Brustkrebs, PPD, RECARDIO, Recordati, Relaxera, Roche, Servier, Viatris, Vifor, VICO Therapeutics; all outside the submitted work.All other authors declare that they have no competing interests.