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Article History

Received: 12 September 2017

Accepted: 21 October 2018

First Online: 6 November 2018

Ethics approval and consent to participate

: This study is conducted under the principles of the Declaration of Helsinki and International Conference on Harmonisation E6 Good Clinical Practice (ICH E6 GCP) guidelines. The study protocol has been approved by the independent medical ethics committee of the Province of Salzburg (Ethikkommission des Landes Salzburg, Austria, EC number 415-E/2067/16–2016) and the Austrian regulatory authority (9308458). The study protocol has been registered on an international primary trial register (ExternalRef removed Identifier: NCT02993094). Written informed consent to participate will be obtained from all participants prior to initiation of any study-specific procedures.

: Not applicable.

: Conflicts of Interest with Takeda®: Employment or Leadership Position: none; Consultant or Advisory Role: Andreas Petzer, Richard Greil; Fees for non-CME services received directly from commercial interest or their agents none; Contracted Research: Richard Greil; Ownership Interest: none; Traveler Grants: none; Marija Balic is on the Editorial Board of BMC Cancer.

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