Tokunaga, Misaki http://orcid.org/0009-0008-0181-7457
Kikuchi, Daisuke
Noda, Aoi
Oikawa, Sachiko
Shiozawa, Makoto
Hino, Hiroaki
Miura, Ryosuke
Usui, Kensuke
Obara, Taku
Okada, Kouji
Funding for this research was provided by:
Japan Agency for Medical Research and Development (22mk0101228h0001)
Article History
Accepted: 18 December 2023
First Online: 18 January 2024
Declarations
:
: This work was partially supported by the Research on Regulatory Harmonisation and Evaluation of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics Project of the Japan Agency for Medical Research and Development (AMED, Grant No. 22mk0101228h0001).
: MT, DK, AN, SO, MS, HH, RM, KU, TO, and KO declare that they have no potential conflicts of interest that might be relevant to the contents of this article.
: We used a database with anonymized information (MDV analyzer<sup>®</sup>); therefore, the requirement of obtaining informed consent from patients was waived. Furthermore, the JADER datasets are available for free downloading from the PMDA website; hence, no administrative permissions or licenses were required to access the data. This study was approved by the Institutional Review Boards of Tohoku University School of Medicine (approval number: 2017-1-506) and Tohoku Medical and Pharmaceutical University Hospital (approval number: 2019-2-066) and was performed in accordance with the tenets of the Declaration of Helsinki.
: Not applicable.
: All data generated or analyzed during this study are included in this published article.
: Not applicable.
: All authors meet the ICMJE authorship criteria. In particular, MT, DK, AN, and TO were involved in study design, data interpretation, and data analysis. SO, MS, HH, RM, KU, and KO interpreted the data clinically. All authors critically revised the manuscript, commented on the drafts of the manuscript, have agreed to the publication of this manuscript in <i>Drugs—Real World Outcomes</i>, and approved the final manuscript.