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Nausea occurred in approximately 24-33% of participants across all tirzepatide doses, but it was most common during dose escalation phases and typically resolved within two to three weeks of stabilizing at a new dose

The applicant stated that it believes that the nominated device meets the substantial clinical improvement threshold, given its novel mechanism addressing unmet need for recurrent nerve compression injuries, and requested that CMS consider the provided clinical data and recognize the Axoguard HA+ Nerve Protector TM as an innovative device offering improved clinical outcomes

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The best practice is to store them in separate vials and draw them into the same syringe just before administration