This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which
will be conducted at one study site. This study will include 3 cohorts. Each cohort will have
approximately 5 subjects. Subjects will not be randomized into the study. The first cohort
will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus
achieving twice the drug levels compared to cohort I and third cohort will receive high dose
drug insert.