Miyachi, Narihisa http://orcid.org/0000-0003-0734-1871
Zagrijtschuk, Oleh
Kang, Lisa
Yonezu, Katsuya
Qin, Albert
Article History
Accepted: 6 March 2021
First Online: 16 March 2021
Declarations
:
: This study was sponsored by PharmaEssentia Corporation.
: Narihisa Miyachi and Katsuya Yonezu are employees of PharmaEssentia Japan KK. Oleh Zagrijtschuk and Lisa Kang are employees of PharmaEssentia Corporation USA. Albert Qin is an employee of PharmaEssentia Corporation, Taiwan.
: The protocol and the informed consent documents were approved by the central ethics committee (Alfred Hospital Ethics Committee, Melbourne, VIC, Australia). The study was conducted in accordance with Good Clinical Practices, International Conference on Harmonisation guidelines, applicable regulations, and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki.
: Written informed consent was obtained from all participants before the initiation of any study-specific procedure in this study.
: Not applicable.
: The study protocol and statistical analysis plan will be shared with those who request data sharing. Requests for the sharing of these documents should be directed to the corresponding author. Requests will be reviewed, and scientifically sound proposals will be approved by the sponsor (PharmaEssentia Corporation). In addition, agreement for data sharing needs to be contracted between data requestors and the sponsor. Data will be shared for 2 years after article publication.
: Not applicable.
: OZ, AQ, and NM designed the study and wrote the protocol. AQ supervised the study. OZ, LK, NM, and KY were responsible for the trial follow-up. LK, AQ, OZ, and NM analyzed/interpreted the data. NM wrote and revised the draft of the manuscript with outside medical writers mentioned in the Acknowledgments section. All authors contributed to and have approved the final version of the manuscript.