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Article History

Received: 15 July 2019

Accepted: 12 October 2019

First Online: 11 February 2020

Compliance with ethical standards

:

: Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. KLY, MBD, and REW are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and may own stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA. HJK is an employee of Certara. Inc., Princeton, NJ, USA, and does not own stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA. SZ was an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, at the time the study was conducted but does not own stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA.

: MODIFY I and II were conducted in accordance with Good Clinical Practice guidelines and the provisions of the Declaration of Helsinki. The protocols and amendments were approved by the institutional review board or independent ethics committee at each study site.

: Written informed consent was provided by all participants before the trial began.