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So it mandated a catchall warning: In case of overdose, consumers should seek prompt medical attention "even if you do not notice any signs or symptoms." McNeil had won a reprieve from having to put a phrase on its bottles that company officials believed scared off buyers: "severe liver damage." And the FDA would not return to the issue until many, many years later

Real-world experience from clinical programs and observational cohorts reinforce trial data and demonstrate more heterogeneity

doi: 10.1016/S2468-1253(18)30231-0 260 BarberioBSegalJPQuraishiMNBlackCJSavarinoEVAlexanderC

Statements Author contributions MS: Software, Writing original draft