14) Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase; 15) Women with a positive pregnancy test en enrollment or prior to study drug administration; 16) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 17) Individual deprived of liberty or placed under the authority of a tutor.