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.