The main concern is that the p value(for overall result) was not given for the null hypothesis. The null hypothesis is that there is no difference between treatment with DMX200 and placebo. Anyone know what the p value(for overall result) was?
There was only a 2% variation from baseline in 24-hour albuminuria after the twelve-week therapy with DMX-200 versus placebo.
The Company stated that a statistically significant difference in the reduction of albuminuria for the primary endpoint was not observed. However, there was a clinically substantial variation in treatment response for patients having elevated levels of albuminuria at study baseline.
Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-507
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