 Design and Pilot Study This is a multicentre international prospective parallel-group double-blind patients and outcome assessors randomized controlled trial. Currently two Centres are involved Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy and Universitätsmedizin Göttingen UMG, Göttingen, Germany. Other Hospitals will be involved after the enrolment of the first 100 patients Pilot study. 