Authors’ contributions
HV, MT, RP, IM, MD, participated in the developing and conception of the study, and drafted the manuscript. MT is the coordinator of the study. MT and MD are medical leads. IM is the statistical lead, designed and will perform statistical analyses. HV and CP are the project managers of the study and are involved in aspects of the day-to-day running of the trial. HV and MD wrote the first draft of this manuscript. CP, AG and CA have revised and modified the manuscript. All authors critically revised the manuscript, gave final approval of the manuscript and are accountable for the accuracy and integrity of the manuscript.