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Both groups presented with more regenerating fibers following the second biopsy, indicating a possible effect of the first biopsy

Protocol Quick-Reference Anti-fibrotic therapy for kidney disease (preclinical) Dosing Amount Not standardized (preclinical IV/infusion doses) Frequency Single or chronic infusion (preclinical) Duration Acute to multiple weeks (study-dependent) Administration Route IV Timing KP1 administered as IV bolus in mouse fibrosis models

doi: 10.1038/s42255-020-0171-3 41 TschpMHFinanBClemmensenCGelfanovVPerez-TilveDMllerTDet al

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

1.8 Other factors of Pharmacokinetic alterations Age and poly-pharmacy are equally responsible for the PK variability