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Article History

Received: 9 February 2023

Accepted: 5 July 2023

First Online: 24 July 2023

Declarations

:

: The studies were conducted in accordance with the Declaration of Helsinki, local independent ethics committee/institutional review board requirements, and good clinical practice guidelines. The need for informed consent was waived as these safety studies were mandated by the Japanese regulatory authorities in accordance with the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (Pharmaceutical and Medical Device Act). The clinical study protocol and other study-related documents were reviewed and approved by the local or central IRBs of study sites.

: Only patients who provided permission for publication (n = 307, see Fig. ) were included in the safety analysis population presented in this publication.

: Chae Sung Lee and Mina Tsurumi are employed by Sanofi. Yoshikatsu Eto is a paid consultant to Sanofi.