The primary reason for creation of this protocol amendment was to include additional visual safety assessments, as requested by the United States Food and Drug Administration (FDA). 1- Dilated fundoscopic examination at the EOT and at the 1-month follow-up visit. These assessments were in addition to the dilated fundoscopic examination already required at the time of Screening. 2- Confrontational and/or automated visual field test at the time of Screening and at the EOT in subjects 5 years of age and older. For subjects who were critically ill and/or clinically unstable at Baseline, visual field testing could be performed at a later time, when, in the investigator’s judgment, the subject was clinically stable and able to perform the test adequately. 3- In subjects 3 years of age and younger, visual safety monitoring was limited to visual acuity and dilated fundoscopy. In children who were too young to perform the visual acuity test, fixation should have been assessed as to whether it is central, steady or maintained in each eye. 4- Assessment of vital signs, and signs and symptoms of Candida infection (including radiologic findings) every 3 days was no longer required in subjects who have been discharged from the hospital and are continuing to receive study drug treatment on an outpatient basis. 5- In subjects who experience a treatment-emergent cardiac arrhythmia that was felt to be, in the investigator’s judgment, clinically significant, the investigator was to collect a standard 12-lead electro cardiaography (ECG) at the time of the event, or within 2 hours following the event, and send a duplicate of the ECG to the designated central ECG reader.

Regarding the primary and salvage EC inclusion criteria: In addition to symptoms consistent with EC, subjects who could not undergo esophagoscopy due to neutropenia, thrombocytopenia, or HIV/advanced AIDS, were to have culture-proven oropharyngeal candidiasis in order to qualify for study entry.