Authorship statement
CLT proposed the concept for study and contributed to the design of the
study. JF participated in design of the study, preparation of the
protocol, case report form, acted as the medical monitor, review of
data/analyses, internal and external presentation and preparation of
clinical study report. YWH, CWT and AQ contributed to the writing of the
manuscript and interpretation of the data. RL was principal investigator
to conduct study and contributed to acquisition, analysis and
interpretation of data. All authors reviewed and approved the final
manuscript.