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First, the study used a limited sample size of only four donors
Visual and olfactory signs of degradation including re-cloudification after clear dissolution, yellow tint, and sulfur smell are legitimate indicators to discard a vial, not rinse and retry
Search for the docket number, follow the prompts, attach files where useful, and label them with names a reviewer can scan in a list (a clinical safety summary belongs in a file whose name says so)
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