Miyazaki, Jun
Onozawa, Mizuki
Takahashi, Satoshi
Maekawa, Yuka
Yasuda, Mitsuru
Wada, Koichiro
Maeda, Yuji
Masaki, Takuro
Yamaguchi, Akito
Suzuki, Masahiko
Sakai, Yasuyuki
Kimura, Tomokazu
Takai, Manabu
Seike, Kensaku
Hashimoto, Takahiko
Yamamoto, Shingo
Funding for this research was provided by:
Japan Society for the Promotion of Science (18H02934, 17K11124)
Article History
Received: 18 June 2019
Accepted: 13 December 2019
First Online: 27 December 2019
Ethics approval and consent to participate
: This study protocol was approved by the Tsukuba University Protocol Review Committee (H26–168), the Tsukuba Clinical Research & Development Organization (T-CReDO), and the institutional review board of each participating hospital before the initiation of the study. This study was performed in accordance with the international ethical recommendations stated in the Declaration of Helsinki [CitationRef removed] and the Japanese Ethical Guidelines for Epidemiological Research. The T-CReDO conducted central monitoring to ensure the integrity of the data submission and patient eligibility and the study’s on-schedule progress.Written informed consent was obtained from all participants.<b>Full names of the ethics committees</b>Table removed
: Not applicable.
: The authors declared that they have no competing interests. The clinical data accumulation was performed by the Tsukuba Clinical Research & Development Organization (T-CReDO). Cook Medical Co. paid T-CReDO for the data collection costs.