Women of child-bearing potential were
allowed to enroll provided they agreed to avoid pregnancy
through 30 days after the last dose of study medication, had a
negative test for pregnancy (urinary β–human chorionic gonadotropin),
and agreed to use an effective birth control
method. Participants had to be prepared to attend clinic visits.
Only 1 participant per household was allowed. Exclusion
criteria are summarized in the Box.No financial incentives were provided