Author contributions
AVN
JA, JS, LA and LB had full access to all data and guarantee data integrity. AVN, HJB, JA, LB, LH, MS, NJ and PRT were responsible for the trial design and for creating the study protocol. Patient enrolment and data collection were done by JS, LA and ED. Data management was performed by Simbec-Orion, JS and LA. Statistical analyses, interpretation of the data and drafting of the manuscript were done by JA, JS, LA and LB. All authors revised the manuscript. JA, JS, LA and LB were responsible for the decision to submit for publication. All authors read and approved the final manuscript.