4. Recipients for whom the current, predose clinical course of CMV infection suggests that the investigator would not be able to withhold treatment for CMV for a minimum of 5, but preferably 7 days following the subject's first dose of study drug. [Note: Patients who, with a high probability, will not be able to have their first efficacy assessment because of CMV infection should not be enrolled into the study. That is, investigators should not enroll recipients with increasing CMV viral loads predose such that, in the PI's opinion, continuation along the same clinical course would result in discontinuation (due to requirement for CMV treatment with a prohibited medication) within the first week.]