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More than 2,000 files were obtained from Federal, State, Tribal, and local partners and used in the update process

doi: 10.1016/j.domaniend.2009.08.005 9

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The following serious adverse reactions are described below and elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice