Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints
Table 2
Different levels of evidence required to graduate treatment for efficacy.
The ordering is hierarchical in nature, i.e. requiring two levels of evidence means level 1 and level 2 need to be simultaneously fulfilled. E1 and E2 refer to endpoint 1 (resolution of NASH without worsening of fibrosis) and endpoint 2 (1-stage fibrosis improvement without worsening of NASH) respectively.