Female participants and pregnancy

To be defined as a woman of non-child-bearing potential, one of the following criteria must be met:

A physician documented history of hysterectomy (removal of the womb) and/or bilateral oophorectomy (removal of both ovaries); or

Aged > 55 years and post-menopausal (stopped menstrual periods) for > 24 months.

All other women are considered to be women of child-bearing potential. Appropriate precautions will be taken in the research study to guard against inadvertent exposure of fetuses to study drugs and to inform individuals of potential risk and the need for precautions. To minimise the possibility of fetal exposure in female participants of child-bearing potential, pregnancy testing will be performed at (screening visit) to detect unsuspected pregnancy before initiation of study treatment. If negative, the individuals must also not be planning a pregnancy for the duration of the study. All efforts will be made by the investigator to ascertain that the study participants will responsibly employ a reliable method of contraception or abstinence for the duration of the drug/treatment exposure. If requested, the investigator will refer the individual to a knowledgeable counsellor or physician for contraceptive advice. Should a participant become pregnant during the study or within three months of completing treatment, she must advise the investigator who will liaise with their obstetrician.