Figure 1

Subject disposition through the end of the study period. ^aIntent-to-treat population. ^bIncludes 1 subject with an SAE of visual disturbance who discontinued drug after 1 dose and did not complete the study; 2 additional subjects discontinued drug after receiving < 5 doses of study drug (1 with erythema multiforme after 2 doses and 1 with staphylococcal scalded skin syndrome after 3 doses, both in the M/P group), but since they were followed through the end of the study period are classified as having completed the study, thus they are not included in this total. ^cIncludes 1 subject for whom consent was withdrawn on day 13 and who died of a bowel obstruction on day 153. ^dCompleted the study through study days 270-300 (120-150 days after the final dose).