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No reproductive toxicity or teratogenicity has been documented in the Russian preclinical dossier, but Western long-term human safety data beyond 30 days do not exist

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Adequate protein (0.8-1g per pound of body weight) preserves lean mass while the deficit targets fat

We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure