Funding for this research was provided by:
Japan Society for the Promotion of Science (16K11872)
Received: 5 October 2019
Accepted: 24 February 2020
First Online: 23 March 2020
Ethics approval and consent to participate
: The study protocol conforms to the Helsinki Declaration [CitationRef removed] and the Ethics Guidelines for Clinical Research notified by the Ministry of Health, Labor, and Welfare, Japan [CitationRef removed]. The study is projected and organized according to the Consolidated Standards of Reporting Trials 2010 guidelines [CitationRef removed]. This trial is registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000022079. The study protocol was recognized by the Ethics Committees of Kanagawa Dental University, Kanagawa Dental University Yokohama Clinic, Iwasaki Internal Medicine Clinic, Yokohama City University Hospital, and Okayama University. The protocol and informed consent forms were accepted by the Ethics Committee at each of the participating institutions. Informed consent will be obtained from all participants prior to registration. During and after the trial, we are committed to complying with the requirements of all Institutional Review Boards/Independent Ethics Committees.The Ethics Committee of Kanagawa Dental University Hospital approved the study protocol on 21 August 2015. This trial is registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (unique ID: UMIN000022079, date of registration: 15 July, 2015). Written informed consent will be obtained from all participants before enrollment. The protocol and any information supplied to gain informed consent were approved by a qualified Institutional Review Board/Independent Ethics Committee prior to subject enrollment.
: Not applicable
: The authors declare that they have no competing interests.