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Batch: GF-IPA10-B241 Key analytical results include: Assay Content: 10.40 mg Identification Retention Time: 0.981 Identification Spectrum: 996 Purity: greater than 99.8 percent Bacterial Endotoxins: below 0.001 EU per mg Total Aerobic Microbial Count: not detected Total Yeast and Mold Count: not detected Independent heavy metal screening confirmed no detectable levels of arsenic, cadmium, cobalt, lead, nickel, mercury or vanadium

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N Engl J Med 318(20):13151321

however, there was a range of 18.9 to 23.4% rise in TCAR