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Article History

Received: 30 May 2023

Revised: 31 October 2023

Accepted: 12 November 2023

First Online: 15 December 2023

Declarations

:

: KN: Has received grants, personal fees, and non-financial support from Chugai Pharmaceutical Co., Ltd; personal fees from F. Hoffmann-La Roche Ltd; grants, personal fees and non-financial support from Sysmex Co.; grants and personal fees from Takeda Pharmaceutical Co.; grants and personal fees from Sanofi S.A.; personal fees from CSL Behring Co.; grants and personal fees from KM Biologics Co.; grants and personal fees from Novo Nordisk A/S; grants and personal fees from Bayer AG; grants and personal fees from Bioverativ Inc; and grants and personal fees from Shire Plc; and is a co-inventor of a patent related to an anti‐FIXa/FX bispecific antibody; TF: Has received speaking and consulting fees from Chugai Pharmaceutical Co., Ltd, Takeda, Sanofi, Novo Nordisk, CSL Behring and JB, and has received research funding from Chugai Pharmaceutical Co., Ltd; AS: Has received speakers’ bureau from Chugai Pharmaceutical Co., Ltd; AN: Has received investigator-initiated grant funding from Takeda (Shire) and Bayer; and honoraria from Sanofi, Takeda, Chugai Pharmaceutical Co., Ltd, Bayer, Fujimoto, KMB, Pfizer, JB, Novo Nordisk, and CSL Behring; CN: Has received speakers’ bureau from Chugai Pharmaceutical Co., Ltd, and Sanofi; MN: Has received advisor fees from Chugai Pharmaceutical Co., Ltd; NS: Has received speaker fees from Chugai Pharmaceutical Co., Ltd, Takeda, Novo Nordisk, CSL Behring, Bayer Yakuhin, Ltd, and Japan Blood Products Organization; DN: Employee of and stockholder in Chugai Pharmaceutical Co., Ltd; TS: Employee of Chugai Pharmaceutical Co., Ltd; YS: Employee of Chugai Pharmaceutical Co., Ltd; KA: Has received consulting fees from Chugai Pharmaceutical Co., Ltd.; has received speakers’ bureau from Bayer, Chugai Pharmaceutical Co., Ltd, CSL Behring, Japan Blood Products Organization, KM Biologics, Novo Nordisk, Pfizer, Sanofi, and Takeda; has received research funding from KM Biologics; and is listed as an entity’s board of directors or advisory committee member for Chugai Pharmaceutical Co., Ltd.

: The TSUBASA study is being conducted in compliance with the International Conference on Harmonisation Guidelines for Good Clinical Practice, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and the Declaration of Helsinki. The study protocol was approved by the research ethics committee at each study site.

: Eligible participants provided informed consent before entering the study.