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Article History

Received: 12 August 2019

Accepted: 13 May 2020

First Online: 1 June 2020

Ethics approval and consent to participate

: The responsible investigator will ensure that this study is conducted in agreement with either the Declaration of Helsinki (in its current version) or the laws and regulations in its current version. The protocol has been written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice (reference: ). The protocol (AIO-STO-0217) is approved by the independent ethics committee of the medical council Hamburg by processing number PFV 5611. Before a subject’s participation in the clinical study, the investigator must obtain written informed consent from the subject. All subjects will be informed of the aims of the study, the possible adverse events, the anticipated benefits, the procedures and possible hazards to which he/she will be exposed, and the mechanism of treatment allocation the subjects also will be informed about alternative treatments. Subjects will be informed of their insurance protection and the obligations which are linked to insurance.

: Not applicable.

: AS received institutional research grants from Merck, Bristol-Myers Squibb, Roche, Sanofi and Servier and serves as an advisory board member for Merck, Bristol-Myers Squibb, Merck Sharp and Dohme, Roche, Sanofi and Amgen. CB is a speaker for BMS and Roche and received institutional research grants from GECI network. AK serves as a consulting or advisor for Bristol-Myers Squibb and received honoraria from Bristol-Meyers Squibb. AH is a speaker for Sanofi and Roche. DP has an advisory role with Roche, Lilly, PharmaMar, and Clinigen; is a speaker for Lilly and PharmaMar and has received research grants from Lilly, PharmaMar, Novartis, and Clinigen. PT has an advisory role with Lilly, Bristol-Myers Squibb, Merck Sharp and Dohme, Roche, Pfizer, Merck, Servier and received institutional research grants from Merck, Novartis.