Table 3:

GPAD-3 Inclusion and Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

176 males or females ≥21 and ≤85 years of age. Female subjects must be (a) post-menopausal, (b) surgically sterile, or (c) use adequate birth control and have a negative pregnancy test within 3 days prior to administration of study drug and should not be breastfeeding Documented symptomatic PAD Clinically stable (≥2 months) history of intermittent claudication or walking impairment (Rutherford Class <II) with no change in symptom severity in the 2 months prior to screening Statin therapy use for previous 3 months, unless statin intolerant PWT between 1 and 12 minutes on a standardized Gardner treadmill protocol or less than 12 minutes on a modified Bruce protocol in case PWT on Gardner protocol is more than 12 minutes Doppler-derived ABI <0.90 in the symptomatic limb after 10 minutes of rest at screening. For subjects with an ABI of >1.3 (non-compressible arteries) a TBI <0.70 must be obtained for subject qualification, or if ABI is >0.9 to 1.0, and a reduction of 20% in ABI measured within 1 minute of treadmill testing On appropriate and stable medical therapy for atherosclerosis for ≥2 months. Diabetes patients with a dilated eye exam excluding proliferative retinopathy in the previous 12 months Ability to give informed consent

Recent or current active infections treated with antibiotics Recent (6 months) or current active cancer undergoing treatment Recent (3 months) change in statin or cilostazol therapy Critical limb ischemia either chronic (Rutherford Class ≥II) or acute ischemia manifested by rest pain, ulceration, or gangrene Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment Planned participation in a structured exercise treatment protocol in the future or within period of study Prior myeloid malignancy Unstable angina, myocardial infarction, transient ischemic attack, stroke or revascularization in the preceding 4 months Severe heart failure (NYHA Class III or IV) or heart muscle disease Limitation on exercise for symptoms other than intermittent claudication such as arthritis or dyspnea Below- or above-knee amputation; wheelchair confinement Use of a walking aid other than a cane Walking impairment for reasons other than PAD e.g. Parkinson’s disease Uncontrolled diabetes mellitus (defined as HbA1c >10.0%) Chronic renal disease (creatinine >2.5 mg/dl) or hepatic disease (>3X elevations in AST and ALT) Ophthalmologic conditions associated with a neo-vascular response Alcohol or drug abuse, or any other disease process that, in the opinion of the principal investigator, will interfere with the ability of the patient to participate in the study Inability to attend study visits

Abbreviations: PAD = peripheral arterial disease, PWT = peak walk time, ABI = ankle-brachial index, TBI = toe-brachial index, NYHA = New York heart association, HbA1c = glycated hemoglobin, AST = aspartate aminotransferase, ALT = alanine aminotransferase