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"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)

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During that time, the surrounding tissue responds to the presence of a foreign protein, producing localized inflammation

Significant regional changes in all three BSC spectrum-based parameters (iBSC, slope, and y-intercept) were observed at post-injury time points (Figs