- subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device); in cases where subjects use hormonal contraceptives, their administration should be discontinued at least 2 months prior to the study commencement date;