Author contributions
AE, TF, RM and PMG conceptualised and designed the study, as well as provided continuous review and oversight of the running of the study along with PFP and JS. AE, DO, EC, LC, JW, SS and ADM recruited participants, collected, and interpreted data. JH set up the randomisation algorithm and contributed to the power analysis and statistical analysis plan. All authors participated in the writing and editing of this manuscript and approved the final submitted version. The corresponding authors had final responsibility for the decision to submit for publication.