Fukushima, Satsuki http://orcid.org/0000-0002-9481-8860
Asakura, Koko
Hamasaki, Toshimitsu
Onda, Kaori
Watanabe, Takuya
Shiose, Akira
Ono, Minoru
Fukushima, Norihide
Yamamoto, Haruko
Fujita, Tomoyuki
Funding for this research was provided by:
Baxter Healthcare Corporation
Article History
First Online: 22 May 2020
Compliance with Ethical Standards
:
: Standard Protocol Items: Recommendations for Interventional Trials checklist of this study.
: The National Cerebral and Cardiovascular Center and Baxter Healthcare Corporations have a research agreement. The funder has no role in the study design, data collection and analysis, interpretation of results, manuscript preparation, or decision to publish. The authors declare no competing interests.
: All procedures performed in studies involving human participants were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, and with the Japanese Pharmaceutical Affairs Act and related laws and regulations. The protocol was approved by the National Cerebral and Cardiovascular Center Institutional Review Board and will be approved by each institutional review board of all participating centers before patient enrollment begins. A clinical trial notification for an investigational device exemption was accepted by the Japanese regulatory agency before trial commencement. Written informed consent will be obtained from all patients when they are recruited. Personal information about potential and enrolled participants will remain confidential, and data will be de-identified using participant numbers.