Author Contributions
D.E.M. had overall responsibility for study design and oversight, protocol and manuscript authorship, data acquisition, data interpretation and manuscript approval. N.P. was responsible for study design, data acquisition and interpretation, clinical trial conduct, and manuscript review. P.C., R.S., G.S., F.S. and R.A.T. were responsible for study design, data acquisition and data interpretation, and manuscript review, editing and approval. All authors have read and agreed to the published version of the manuscript.