 - A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptives methods during the study and at least 3 months after discontinuations of the investigational product is required. The following contraceptive methods are regarded as effective: intrauterine devices, hormonal contraceptives contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release. Sterilised or infertile patients are exempt from the requirement to use contraception. In order to be considered sterilised or infertile, patients must generally have undergone surgical sterilisation vasectomybilateral tubectomy, hysterectomy or bilateral ovariectomy or be postmenopausal defined as 12 months or more with no menses prior to enrolment 