Composition of the data monitoring committee, its role and reporting structure 
RECRUITMENT
During the process of obtaining ethical approval for this single-site study, a Data Protection Impact Assessment (DPIA) screening tool was completed. This was analysed by the hospital’s data protection officer (DPO) in MMUH and the DPO of the Host Institution, University College Dublin (UCD). It was deemed that this study posed a low risk to the rights and freedoms of natural persons and therefore a formal DPIA was not needed. Recruitment of participants is expected to be completed within less than 12 months or once the required number of participants needed is fulfilled. Due to the rapid expected inclusion of participants and the known minimal inherited risks associated with this trial, a data monitoring committee was not appointed.