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Article History

Received: 18 September 2018

Accepted: 16 January 2019

First Online: 8 February 2019

Ethics approval and consent to participate

: All three study protocols and amendments were approved by appropriate institutional review boards and ethics committees at each institution. The studies were done in accordance with the protocols, Good Clinical Practice guidelines, and the declaration of Helsinki. All patients provided written informed consent. The studies were registered on.

: Not applicable.

: MW, CC, TJ, JA, NL, PK, NI and SE are employed by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and hold stock in the company. CH serves as a research consultant for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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