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In response to our concerns, the applicant commented that it is committed to providing the clinical evidence necessary to satisfy the substantial clinical improvement standard and indicated that it is currently conducting an ongoing prospective, multicenter, open-label, single-arm clinical study [44] to evaluate the Axoguard HA+ Nerve Protector TM in patients undergoing a first revision cubital tunnel decompression procedure for recurrent or recalcitrant cubital tunnel syndrome

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Then, each ring was washed and re-equilibrated for 60 min

General anesthesia was induced using injection midazolam 1 mg, fentanyl 120 g, propofol 100 mg, and atracurium 30 mg for tracheal intubation