Document is current

Article History

Accepted: 28 May 2021

First Online: 10 June 2021

Declarations

:

: This study was funded by Amgen, Inc.

: AT, MM, PJ, HZ, BT, AB, SD, and EL are employees and shareholders of Amgen, Inc. SF has no relevant funding or compensation to disclose.

: Qualified researchers may request data from Amgen clinical studies; complete details are available at http://www.amgen.com/datasharing.

: Not applicable.

: AT, MM, SD, and EL participated in the conception and planning of the study; all authors participated in the design of the study. All authors participated in the acquisition, analysis, and interpretation of data. All authors critically revised and approved the final version of the manuscript.

: The study was conducted in accordance with ethical guidelines from the Declaration of Helsinki and Council for International Organizations of Medical Sciences, applicable Good Clinical Practice guidelines of the International Council for Harmonization, and applicable local laws and regulations. A Salus (Austin, TX, USA) institutional review board approved the research protocol and study-related documents.

: All study subjects provided written informed consent before enrollment in the study and could withdraw from the study at any time.

: Not applicable.

: The authors would like to thank Yuan-Hon Kiang and Bhanu Bejgum from Process Development, Amgen Inc. for providing valuable information related to formulations.