Tauchmanova, Libuse
Breitschaft, Astrid
Holder, Geoffrey
Han, Kevin Tianxiang
Choudhury, Somesh
Darstein, Christelle
Paul, Michaela
Drutinus, Eric
Gericke, Germo
Schmid, Herbert A.
Pedroncelli, Alberto M.
Article History
Received: 12 May 2021
Accepted: 11 October 2021
First Online: 6 November 2021
Compliance with ethical standards
:
: L.T. is a former employee of Novartis. A.B. is an employee of Parexel International GmbH; Parexel International GmbH was paid by Novartis Pharma AG for assistance in conducting the study. G.H., K.T.H., S.C., C.D., M.P., E.D., G.G. and H.A.S. are employees of Novartis. A.M.P. is a former employee of Novartis and a current employee of Recordati.
: The protocol and all amendments were reviewed and approved by the Berlin State Ethics Committee (Turmstraße 21, Haus A, Berlin 10559, Germany). The study was conducted according to the ICH E6 Guideline for Good Clinical Practice and the ethical principles of the Declaration of Helsinki.
: All subjects provided written consent to participate.