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Article History

Received: 28 February 2022

Accepted: 18 May 2022

First Online: 7 June 2022

Declarations

:

: JN, AH, AS, and MI are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ USA, who may own stock and/or hold stock options in the Company. AF, PB, and MK were employees of Afferent Pharmaceuticals at the time of the study (now acquired by Merck & Co., Inc., Rahway, NJ, USA) and may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. SS was a consultant for Afferent Pharmaceuticals at the time of the study (now acquired by Merck and Co., Inc., Rahway, NJ, USA).

: This study was conducted in compliance with International Conference on Harmonisation Technical Requirements for Registration of Pharmaceuticals for Human Use E6, Good Clinical Practices: Consolidated Guidelines and any additional national or institutional review board-required procedures. The study protocol was approved by the Celerion Institutional Review Board and conducted at Celerion (Tempe, AZ).

: All participants provided written informed consent before enrollment.

: Not applicable.