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As dozens of novel agents currently under study seek new indications, the question arises of whether the traditional practice of two confirmatory trials for every indication expansion remains justified, especially when database study emulations that benchmark against previously conducted, closely related reference trials have yielded aligned results 33,34

doi: 10.1111/j.1574-6941.2006.00103.x 187 PelosiP.GazzaL.BeniC.BarbiniD

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