Female subjects aged ≥10 years or of childbearing potential (i.e., started menses) were excluded if not either using or willing to use a medically acceptable form of contraception (i.e., oral contraceptive pill, surgical sterilization, implant or injected form of contraception, or intrauterine device), or prepared to abstain from sexual activity for the duration of the study and for 1 month after last administration of study medication.