The randomization will be 2:2:2:1 (into the treatment doses of 10 mg/day of GLU-001, 20 mg/day of GLU-001, 50 mg/day of GLU-001, and Placebo). The study will enroll 210 evalauble patients . If the evaluable sample size is planned to be 210 across the four treatment groups combined, how many total patients should be randomized in order to achieve this number, assuming that 7.5% of patients will dropout before their evaluation at 28 days post-baseline. Use SAS proc power