 - are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial until 28 days after the last treatment administration, and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, vasectomized partner, transdermal patch, intra uterine devicessystems IUDsIUSs, combined estrogen-progestin oral contraceptives as well as implantable or injectable hormonal contraceptives. Complete sexual abstinence if acceptable by local health authorities is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g., calendar, ovulation, symptom-thermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. Double barrier methods are permissible if acceptable by local health authorities, note that this is not an acceptable method in EU countries. 