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Selected part 2 safety/tolerability and efficacy endpoints are reported.
Efficacy endpoints should be selected to reflect clinical benefit.
For instance, efficacy endpoints are often subjective and highly variable.
There are no primary safety and/or efficacy endpoints for this study.
It can be applied to phase II oncology trials with two independent co-primary efficacy endpoints.
About half (200) were classified as trials with both safety and efficacy endpoints.
Secondary efficacy endpoints are the changes in UACR, serum cystatin C and serum creatinine from baseline.
The secondary efficacy endpoints showed no statistically significant differences between the two arms.
Total scores of the Hamilton Depression Rating scale (HAM-D) were used as efficacy endpoints.
Clinical efficacy endpoints included the 6-min walk test (6MWT) and pulmonary function testing.
Most efficacy endpoints are based on specified clinical assessments of patients.
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