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10.1001/jamaoncol.2023.5573 112 WernerR.McCormickB.PetrekJ.CoxL.CirrincioneC.GrayJ
Incorporate plenty of vegetables, fruits, and whole grains
While a 6-month follow-up period is commonly used to determine outcome of therapeutic interventions in IIH studies, we intend to further follow up the patients and also recruit new ones to obtain more long-term data
The drug has been studied in human trials, including a Phase 2 trial published in The Lancet in 2008 and a Phase 3 trial in 372 patients in Mexico, but a dedicated cardiovascular outcomes trial that US and EU regulators would expect has not been run
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