Document is current

Article History

Received: 26 January 2023

Accepted: 2 May 2023

First Online: 8 May 2023

Declarations

:

: Research ethics committee of Kashima Hospital, Fukushima, Japan (reference number: 2022002). Written, informed consent to participate will be obtained from all participants. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage.To ensure proper communication and adherence to the protocol, the Principal Investigator will follow a strict notification process. Any substantial amendments to the original approved documents will be submitted to and, where necessary, approved by the sponsor and funder before the Principal Investigator notifies and send a copy of the revised protocol to the GP practices. In addition, any deviations from the original protocol will be fully documented using a breach report form. We will also update the protocol in the clinical trial registry to ensure that all stakeholders have access to the latest version of the study protocol.

: Not applicable.

: The authors declare that they have no competing interests.