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[13] In applying this threshold analysis, the FDA addressed and rejected several arguments premised on higher-strength injections, microdosing beyond labeled titration, alternative routes of administration such as buccal or sublingual, excipient sensitivity such as avoiding propylene glycol, multi-ingredient combinations with pyridoxine or antiemetics, and device or dose-adjustment preferences

doi: 10.3389/fpls.2019.01470 9 AmaglianiL.O'ReganJ.KellyA

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