Contribution statement
AMH designed the study, interpreted the data and contributed to the discussion and development of the manuscript. MB and JR contributed to the conduct of the study, participated blindly in the safety monitoring committee, interpreted the data and contributed to the development of the manuscript. RM was the clinical trial lead in coordinating all activities in the conduct of the study. JH planned and conducted the statistical analyses and supported the design of the study and interpretation of data. All authors had full access to all of the data in the study, drafted the work or revised it critically for important intellectual content, and approved the final version of the manuscript and accept responsibility to submit for publication. AMH is the guarantor of this work.