The Original Study 3004 protocol instructed providers to treat diarrhea at the very first occurrence. Subjects were to have ready access to antidiarrheal agents (Loperamide preferred) at home starting on Day 1 of treatment and were to be encouraged to contact the site to report and discuss the severity of diarrhea and the appropriate course of treatment. If clinically indicated, stool cultures were recommended to exclude infectious causes of Grade 3 or 4 diarrhea or diarrhea of any grade with complicating features (dehydration, fever, and/or grade 3 -4 neutropenia).