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Table 20 Necrosis scores 6 days post injections of subcutaneous tissue necrosis for co-formulation necrosis for co-formulation vehicles varying in percentage HP-B-CD Concluding Remarks A correlation was observed between increased HP-B-CD concentration in the coformulation vehicle and necrosis at the injection site

The injection site should not have any swelling, redness, bruising, hardness, change in the skin texture or color, irritation, pain, or dilated veins

This document is reviewed by an independent Institutional Review Board (IRB) and details all possible risks that have been reported or that may happen to you while in the trial