 13. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraception intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release. Effective contraception must be used for the duration of the study and for at least 13 days after participating in the study. Effective contraception must be used by men and women for the duration of the study and for at least 13 days after participating in the study. 