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Freshly prepared AX in PBS was incubated in the absence or presence of purified HSA purified from serum for 16 h at 37C (final concentrations of HSA and AX in incubation mixture were 3 mg/ml and 2.5 mg/ml, respectively)
The FDA cited concerns including potential heart-related adverse events in available safety data and the general Category 2 rationale of insufficient safety information for compounding
The escalation schedule exists because your body needs time to adjust to each dose level
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