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(ii) Detailed information: Detailed information should include: (a) complete study protocol; (b) method of data analysis; (c) complete study report; (d) study conclusion. For detailed information, when a recognized standard exists that contains the protocol and the method of data analysis, this information can be substituted by a declaration or certificate of conformity to the recognized standard along with a summary of the data and conclusions. Where appropriate, actual test result summaries with their acceptance criteria should be provided and not just pass/fail statements.
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