42 study participants will be included in this double-blind placebo-controlled study. Following enrollment of 42 subjects and completion of the 6-week Treatment Period by all active subjects, an analysis of the treatment effect will be performed for a reassessment of sample size and, if deemed appropriate, the study will continue with enrollment of additional subjects to ensure a more statistically robust interpretation of the data. The results of the statistical analysis will be blinded from Investigators and coordinators. The procedure will be delivered to all subjects who agree to participate, meet inclusion criteria, and sign informed consent.