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Vials may be thawed in the refrigerator [2C to 8C (35F to 46F)] or at room temperature [up to 25C (77F)] [see How Supplied/Storage and Handling (19)]

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5.4 Risk Characterization and Uncertainty The final step in the risk assessment process is risk characterization. Exactly what this includes is site- and situation-specific and should be fit for purpose

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