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Patient disposition. A total of 592 patients were screened; 204 failed screening, and 388 were ultimately enrolled. Of the enrolled patients, 383 were injected with both MHI and 99mTc. One patient was not included in the FAS or SS due to the use of the prohibited drug “methylene blue” as specified in the protocol. At the discretion of the Data Review Meeting, 382 patients were included in the FAS, and 387 patients were included in the SS.
