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The pKPN-US-1 was further subdivided into four subcategories by the presence of IncFII K7 replicon, arsenic resistance genes, and iron transport genes as pKPN-US-1.1 (IncFII K7 +/ ars +/ fec +/sil+), pKPN-US-1.2 (IncFII K7 +/ ars +/ fec -/sil+), pKPN-US-1.3 (IncFII K7 -/ ars -/ fec -/sil+), and pKPN-US-1.4 (IncFII K7 +/ ars +/ fec -/sil-)
Consequently, FDAs conclusion that the quality system does not adequately ensure data accuracy and integrity is consistent with the fundamental principle that data integrity is a system responsibility, not a post hoc justification exercise
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Short-term insulin treatment for a maximum of 14 days prior to screening and previous insulin treatment for gestational diabetes were, however, allowed
Liquid Growth Assays Strains were grown in 5 ml SCD overnight at 30C and then inoculated into a second round of starter cultures in 10 ml volumes and grown overnight
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