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Finally, the applicant highlighted that, while the study is ongoing and data remains subject to final investigator approval and statistical analysis, preliminary, 100 percent source-verified observations to date are consistent with the FDA-cleared intended use and function of the Axoguard HA+ Nerve Protector TM

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J Mol Med 95(3):323333 James R, Kesturu G, Balian G, Chhabra A (2008) Tendon: biology, biomechanics, repair, growth factors, and evolving treatment options