Rothschild, Sacha I.
Betticher, Daniel
Zenhäusern, Reinhard
Anchisi, Sandro
von Moos, Roger
Pless, Miklos
Moosmann, Peter
Popescu, Razvan A.
Calderoni, Antonello
Dressler, Marco
Rauch, Daniel
Pederiva, Stefanie
Woelky, Regina
Papet, Claudia
Bühler, Vera
Borner, Markus
Funding for this research was provided by:
Merck Switzerland
Article History
Received: 23 July 2019
Accepted: 7 August 2019
First Online: 23 August 2019
Compliance with ethical standards
:
: The study was funded by Merck (Switzerland) AG, Zug, an affiliate of Merck KGaA, Darmstadt, Germany. SIR has received honoraria for advisory boards (paid to the institution) from Merck and research funding from Merck. RVM has participated in advisory boards of Merck and Amgen and received speaker honoraria from Amgen and Merck. PM has participated in an advisory board of Merck. VB is a full-time employee at Merck (Switzerland) AG, Zug. The other authors declare no competing interests. The authors confirm they have full control of all primary data and agree to allow the journal to review their data if requested.
: 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.