- Male participants who are sexually active with a partner of child-bearing potential must either be sterile (vasectomy with history of a negative sperm count following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female participants of childbearing potential) from the time of Screening until 90 days after study drug administration. Male participants must agree not to donate sperm for a period of 90 days after study drug administration.