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The nomination did not include the safety, identity, and clinical-rationale data the agency needs to evaluate
Most protocols last 48 weeks, followed by a rest period
Controls simultaneously received an equivolume of saline (5.0 ml/kg intraperitoneally) or water only
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L., OBryan, M
In this context, even modest alterations in angiogenesis, inflammatory signaling, or coagulation balance, as well as contamination exposure, may be clinically meaningful
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