Complete Medical History. A complete medical history will be obtained at Baseline. All positive and negative findings will be carefully documented on the CRF. Any new finding discovered during the Baseline evaluation and prior to the first study drug administration (Day 0) will be considered to be part of the medical history and will not be recorded as an adverse event. The Investigator will perform an especially detailed assessment of past peripheral arterial disease history to include all events and interventions for critical limb ischemia and to excluded other (e.g. structural abnormalities such as fibromuscular dysplasia or connective tissue disorders, inflammatory conditions, thromboembolic disease, impingement/entrapment, venous claudication, etc.).
