Yamamoto, Haruko http://orcid.org/0000-0002-8135-2547
Hamasaki, Toshimitsu
Onda, Kaori
Nojiri, Takashi
Aragaki, Masato
Horie, Nao
Sato, Norihiro
Hida, Yasuhiro
Funding for this research was provided by:
Ono Pharmaceutical Co., Ltd (NA)
Article History
Received: 4 June 2019
Accepted: 15 November 2019
First Online: 11 December 2019
Ethics approval and consent to participate
: 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 Japanese Pharmaceutical Affairs Act and related laws and regulations. The protocol was approved by Hokkaido University 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 a new drug application was accepted by the Japanese regulatory agency before it started. Written informed consent will be obtained from all patients before they are recruited. Personal information about potential and enrolled participants will remain confidential and data will be de-identified using participant numbers.
: Not applicable.
: The National Cerebral and Cardiovascular Center, Hokkaido University and Ono Pharmaceutical Co., Ltd. have a joint 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.