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The OOS investigation process (no corrective actions for failure to notify patients) The root cause of sterility and potency failures (not identified or discussed in the firms responses)

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Note, in general, since the beginning, the concept of cytoprotection did not consider the neurotransmitter activity as the basis for the cytoprotective effects of the implemented agents (i.e., prostaglandins [16,17], sulfhydryl [141], somatostatin [142], dopamine [143])

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