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As a result, determining the appropriate duration of clinical trial length is a balance between having sufficient time to reach the efficacy endpoint and the need to continually assess the risk of chronic exposure over longer periods
For manufacturers that recognize these key factors and have a plan from launch to successfully address them, a path to commercial success can be attainable
Calissi, G., Lam, E
In people with preexisting conditions like chronic kidney disease or liver cirrhosis, high-dose IV infusion may place additional stress on these organs
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