 In this study, participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit Day 0. Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment AZLI TID or placebo TID. Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow-up visit 14 days after the last dose of study drug Day 42. 