 - Female patients of childbearing potential must be willing to use double effective methods of contraception e.g. two of the following: hormonal contraception, condom or occlusive cap, intrauterine device IUD or intrauterine system IUS, male sterilisation, or true abstinence through 3 months after the last IMP administration; male patients must agree to use a double effective method of contraception e.g. two of the following: hormonal contraception, condom or occlusive cap, IUD or IUS, male sterilisation, or true abstinence during heterosexual intercourse with a partner capable of becoming pregnant throughout 3 months after the last IMP administration 