Author contributions
M.McE.
J.F. was the Project Lead on this study and was principally responsible for all aspects of the study design, protocol development, study conduct and manuscript writing. M.McE., J.E., K.T., S.B.W., and G.H. all contributed to the technical development of the study design and the protocol, as well as reviewing and editing the manuscript. J.T. provided study design, power calculations and statistical analysis expertise.