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Five additional groups were vaccinated three times at three-week intervals with the following formulations: AddaS03 adjuvant at a 1:1 volume ratio in a total of 100 L PBS/mouse, AS01 adjuvant (5 g MPL/5 g QS-21 in a total of 100 L PBS/mouse), metE-DNA (100 g/100 L PBS/mouse), 1 g metE protein combined with AddaS03 adjuvant at a 1:1 volume ratio in a total of 100 L PBS/mouse, and AS01 adjuvant (5 g MPL/5 g QS-21 in a total of 100 L PBS/mouse)

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Safety concerns included uncharacterized immunogenicity (the risk that injected peptides trigger immune reactions), inadequate impurity and endotoxin testing in available raw material, the unresolved free base versus acetate salt form distinction, and, for BPC-157 specifically, an angiogenesis mechanism that raises theoretical cancer-risk concerns for certain patient populations

The agency can also decline to follow the committee