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Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))
Electrolytes (sodium, potassium, magnesium) become critical during fasting because tirzepatide can alter fluid and sodium balance
Loss of lean muscle mass has been noted in up to 25% of patients undergoing rapid weight loss
doi: 10.1042/BCJ20160616 13 YoshikawaK
