TABLE 2.

Context-of-use for the qualification opinion of the iBOX Scoring System.

General measurement	The iBOX scoring system is a secondary endpoint prognostic for death-censored graft loss (allograft failure) in kidney transplant patients to be used in clinical trials investigating novel immunosuppressive medicines
Timing of iBOX assessments	The iBOX Scoring System is an acceptable secondary measured between 6 and 24 months postkidney transplantation in pivotal or exploratory drug therapeutic studies for regulatory purposes. The iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared with the SOC at 6, 12, or 24 months postkidney transplant
Target population	Adult kidney-only transplant recipients from a living or deceased donor

SOC, standard of care.