<qa>  What is the name of the study drug that is signed by the investigator?- If female and of childbearing potential or if male, must agree to use adequate contraception e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 6 months after the last dose of study drug. 