The study was an 8 week randomized, double-blind, placebo-controlled study with a pre-study 2 week washout period. The study was conducted at a single site: Medicus Research, LLC, in Northridge, Ca. Sample size was not calculated as this was an exploratory trial to compare three concentrations of the target product to placebo. The study was approved by the Copernicus Group IRB (Cary, NC) prior to the initiation the study.