<qa>  What is a regenerative dysfunction defined as?- Renal dysfunction defined as dependence on dialysis or a creatinine clearance 35 mlmin, assessed within 4 weeks of the Baseline Visit. Creatinine clearance height in cm x 0.55plasma creatinine for all females and for males 13 years old; height in cm x 0.70plasma creatinine for males 13 years old. 