Acknowledgements
We thank the patients who participated in this clinical trial; Chisato Nagata, Tomotaka Sobue, and Yuki Sato for supervising the implementation of the study; Shinobu Masuda and Yoko Nakanishi for immunohistochemistry; Toshiharu Yasugi, Yoko Hasumi, and Takahide Arimoto for service on the Safety Monitoring Committee; Kazuki Ogushi, Yasuchika Onishi, and Yukihiro Fukunaga (Cmic Inc) for their service on the data, safety monitoring board and statistical analyses; CReSCent, the Clinical Research Support Center at the University of Tokyo for independent review of endpoint data; and funding by GLOVACC Co Ltd and the Japan Agency for Medical Research and Development (AMED, 20ck0106446h0003, 21ck0106646h0001). The funder had no role in the design of the study; the collection, analysis, or interpretation of the data; or the writing of the manuscript and decision to submit it for publication.