Demonstrate the efficacy of 30 or 60 mg per day of AS-013 to placebo in subjects with Fontaine stage IV peripheral arterial occlusive disease (PAOD) utilizing the following assessments: reduction in need for major amputation, time to amputate, incidence of complete target ulcer healing, need for any amputation or PAOD-related surgery, and change in functional status. Also, evaluate the dose response relationship of AS-013 in target population, assess the safety of AS-013, and perform exploratory analyses on the effects of AS-013 on neuropathy, insulin requirement, and opiate analgesic consumption.
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