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In women, up to 12 months of use showed no evidence of tissue changes or serious issues emerging.There was no accumulation of effects on blood pressure or heart rate with ongoing use the cardiovascular effects remained transient

The primary endpoint is the time to the first occurrence of a composite primary outcome event, defined as a persistent eGFR decline (50% from baseline), reaching ESRD, renal death, or CV death

There are three voting members, six vacancies and one non-voting member from the pharmaceutical industry

While they are not FDA-approved, they are created in response to drug shortages and can be a more accessible and affordable choice