1. Replacement of Subjects Subjects withdrawn from the study prior to administration of the study drug will be replaced. Subjects withdrawn from the study after administration of the study drug and who do not have a clinical resection performed will not be replaced. Other subjects withdrawn prior to complete 60-day follow up will not be replaced. If subjects do not respond to phone follow-up at 30 or 60 days, three repeated attempts will be made over the 10 days following each of these time points. Subjects who have incomplete follow up will be included with limited follow up.