Funding for this research was provided by:
The Rotunda Foundation, Registered Charity ((CHY20091))
Received: 25 June 2020
Accepted: 6 November 2020
First Online: 19 November 2020
Ethics approval and consent to participate
: The trial was approved by the Health Products Regulation Authority of Ireland in August 2016. National Ethics approval for the trial was granted in September 2016. The clinical trial was assigned a EudraCT number of 2016–003181-12. Each patient gave written consent for participation in the study.
: Not applicable.
: The authors declare that they have no conflict of interests.