 Assuming an expected drop-out rate of 12, a total sample size of 150 patients 75 randomized in each group will be randomized to reject the null hypothesis that the proportion of patients achieving the primary endpoint is 50 in favor of the alternative hypothesis that this proportion is 75 when AOP2014 is added to the phlebotomy based- therapy, with a power of 80 and an alpha error of 0.05 two-tailed. 