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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

In our previous study we described that the A-GSH dual-targeting elevated the BBB penetration of 3-PLGs [24]

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Malaysian J Chem 21(1):96103 Jahan Y, Siddiqui HH (2012) Study of antitussive potential of Glycyrrhiza glabra and Adhatoda vasica using a cough model induced by sulphur dioxide gas in mice

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Among such species the radical forms are removed via non-enzymatic reduction with GSH, whereas the elimination of hydroperoxides requires enzymatic catalysis by GPX and catalase