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Based on our review of the application, we agree with the applicant and have determined that the Axoguard HA+ Nerve Protector TM meets the eligibility criterion at 419.66(b)(3)

10.1016/j.ejphar.2011.10.016 61 LiH.WuX.YangB.LiJ.XuL.LiuH.et al (2019)

Patients were not allowed to use additional treatments for eight hours prior to study medication dosing and during the four-hour observation period following study treatment

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