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An earlier Phase II trial11 and two essentially identical Phase III trials (a study of at least moderate size that compares a new treatment with the current standard of care in patients), Gout 1 and Gout 2 have been presented.13 Data on shrinkage of tophi with this agent was also presented in 6/09.13 Cardiac events have occurred during the studies of Krystexxa®, and the FDA reviewed them closely and concluded that they did not appear due to the medication