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It means the agency did not have reliable human data showing what exposure they produce, whether they help, how often adverse effects occur, or how product variability affects results
A phase I-II study of high-dose thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic marrow transplantation
Different peptides target different biological pathways, which is why the field covers everything from tissue repair to hormone improvement to immune modulation
& Cavallo, M
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