Funding for this research was provided by:
National Institute of Dental and Craniofacial Research (R21DE15128, U01DE018664 and U01DE018837)
Received: 30 March 2020
Accepted: 11 November 2020
First Online: 4 January 2021
Ethics approval and consent to participate
: The protocol was approved from the Multicentre Research Ethics Committee in the UK (MREC number: 09/H1306/119). Ethical approval has been sought in each participating country according to country-specific procedures and from relevant ethics committees for each participating centre. The trial is registered with ClinicalTrials.gov (Identifier: NCT00993551).
: Not applicable.
: The authors have no competing interest to disclose.