The prescriber must ensure that: • The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding. • The patient has acknowledged the aforementioned conditions. • The patient has used at least one and preferably two methods of effective contraception including a barrier method for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment. • Negative pregnancy test results have been obtained before, during and 5 weeks after the end of treatment.