Ethics and dissemination
ADVERSE EFFECTS
Ethics approval was sought from the South East Scotland Research Ethics Committee (REC) 02 and a favourable opinion was received on 30 September 2022 (REC reference: 22/SS/0059). Any amendments to the protocol will be agreed with the REC before being implemented and then amended on the ISCTRN Registry. The findings of the study will be published in an open-access journal once the full trial has been completed. A data monitoring committee was not deemed necessary as participants are adverse effects are not expected in either of the randomisation groups.