The agency continues to require the manufacturer, Eli Lilly, to conduct post-marketing studies, including the SURPASS-CVOT cardiovascular outcomes trial, which will provide extended safety data on over 12,500 patients
10.1016/j.tem.2013.01.002 12
It can endogenously improve melatonin production in older adults and help to restore deep sleep in people who may have lost their ability to have restorative sleep as they age
In general, PT-141 should not be administered more than twice weekly or eight times monthly, since overly frequent administration can increase the risk of side effects such as skin darkening
A high-dose IV gets around that limit
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