Creatinine measures by dose group. The mean creatinine values at each of the study visits shown are represented by mean ± SD. ○ represents the low-dose cohort; and ▵, the high-dose cohort. No significant difference between groups was noted at any time during the study, and the week 24 and study week 28 values did not differ from baseline. Most patients remained on drug for the week 28 measures, in the extension phase of the study. “Week 0” indicates baseline values before administration of FBS0701. Details of creatinine by patient and by treatment group are presented in supplemental Figure 1.