Data Safety Monitoring Committee (DSMC):- DSMC will comprise an independent chair, independent clinician and independent statistician. The chief investigator or study statistician may be invited to attend to provide specific input by the DSMC Chair. The DSMC will be responsible for the interests and safety of the participants and its main role will be to make advisory recommendations to the TSC who will report to the Sponsor. To this end, the DSMC will undertake safety data reviews every six months after the first 5 participants are recruited unless otherwise deemed necessary. In addition, the DSMC will review analysis plans.