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Authors
Hibi, Toshifumi https://orcid.org/0000-0002-6256-1204
Hirohata, Shunsei https://orcid.org/0000-0003-1911-7383
Hisamatsu, Tadakazu https://orcid.org/0000-0002-1178-3536
Kikuchi, Hirotoshi https://orcid.org/0000-0002-1864-1098
Takeno, Mitsuhiro https://orcid.org/0000-0002-9212-7046
Sato, Noriko https://orcid.org/0000-0003-2660-0808
Mizuno, Naomi https://orcid.org/0000-0002-1326-9792
Tashiro, Mayumi
Susuta, Yutaka https://orcid.org/0000-0003-1621-9261
Ishigatsubo, Yoshiaki https://orcid.org/0000-0002-2908-1452
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Funding
Funding for this research was provided by:
Mitsubishi Tanabe Pharma Corporation
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Article History
Received: 24 April 2024
Accepted: 6 September 2024
First Online: 16 October 2024
Declarations
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: The study was funded by Mitsubishi Tanabe Pharma Corporation. T. Hibi., S.H., T. Hisamatsu, H.K., M. Takeno, and Y.I. have received consulting fees from Mitsubishi Tanabe Pharma Corporation. N.S., N.M., M. Tashiro, and Y.S. are employees of Mitsubishi Tanabe Pharma Corporation.
: This study was conducted according to the Japanese Good Post-Marketing Surveillance Practices (GPSP, Pharmaceuticals and Medical Devices Agency, 2004). As per the GPSP, pre-registration as a clinical trial, informed consent, and study protocol approval by the institutional review board were not required for a PMS study. Therefore, no IRB was held for this study. The study protocol was approved through pre-consultation with the Pharmaceuticals and Medical Devices Agency, in accordance with the GPSP. Data were made unidentifiable to individual patients, ensuring patient confidentiality and transparency regarding data privacy.
