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Article History

Received: 21 November 2020

Accepted: 22 March 2021

First Online: 31 March 2021

Declarations

:

: Informed consent was received from all participants prior to performing any study-specific procedures to conform to all applicable local, regulatory, and ethical requirements. The study protocol and any amendments and modifications were reviewed by appropriate institutional review boards, research ethics boards, or independent ethics committees for each participating study site prior to implementation. The SCARLET study was conducted in compliance with the International Conference on Harmonisation Good Clinical Practices. The study was approved by appropriate ethics committees, as detailed in the previously published SCARLET study protocol.

: Not applicable.

: BF was a member of the main SCARLET trial steering committee. BF reports personal fees from Asahi Kasei Pharma America Corporation during the conduct of the main SCARLET study and personal fees from Inotrem, Biomérieux, Aridis, AM-Pharma, Ferring, Transgene, and Enlivex outside of the current work. JLV reported receiving grants from Asahi Kasei Pharma America Corporation during the conduct of the main SCARLET study. JH reported honoraria from Stago. JBL reported receiving consultation fees from Asahi Kasei America Corporation. KT, TK, and DF are employees of Asahi Kasei Pharma American Corporation. EM and XW declare that they have no competing interests.