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Article History

Received: 3 December 2019

Accepted: 25 August 2020

First Online: 15 September 2020

Ethics approval and consent to participate

: The leading ethics committee of the state’s association of physicians of the principal investigator, Dr. Rainer Krügel, practicing medicine in the state of Brandenburg, has voted that the study does not violate any ethical consideration, and the ethics committees, namely Landesärztekammer Brandenburg, of physicians associations of German states, namely the free state Saxony, the free state Thuringia, and the state of Saxony-Anhalt and the state of Brandenburg, have endorsed and granted the approval of the study protocol, which is sponsored by Signature Diagnostics GmbH, a 100% subsidiary of Roche Deutschland GmbH (Reference number S 26(a)/2013). All patients provided written informed consent to participate in this study.

: Not applicable.

: John Jiang, Hans-Peter Adams, Maria Lange, Sandra Siemann, Mirjam Feldkamp, Sylvie McNamara, Stephanie J. Yaung, Lijing Yao, Aarthi Balasubramanyam, Nalin Tikoo, Christine Ju, and John F. Palma are salaried employees of F. Hoffmann-La Roche. Sebastian Froehler is a salaried employee of F. Hoffmann-La Roche, Basel, Switzerland. H. Jost Achenbach reports personal fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Novartis, Insmed, Grifols and Roche outside the submitted work. Rainer Krügel reports personal fees from Bristol-Myers Squibb, Boehringer Ingelheim, Novartis, Merck Sharp & Dohme, Mediolanum, and Roche outside the submitted work.