(one) The appliance must comprise the full text of all the knowledge explained in the next sections:

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(G) The title and site of your testing laboratory or laboratories and documentation exhibiting that the laboratory or laboratories is (or are) accredited by a nationally or internationally regarded external accreditation Corporation;

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original research documents prepared within a language besides English) must be accompanied by: The original language Edition of the document, signed an announcement by a certified agent on the company certifying that the English language translation is finish and correct, and a short statement of your qualifications with the person who manufactured the interpretation.

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implies any unfavorable Actual physical or psychological influence in a person who is temporally associated with the usage of or publicity to some tobacco products, whether or not the individual uses the tobacco merchandise, and whether the impact is regarded as related to using or exposure into the tobacco merchandise.

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(iv) Copies of all versions of investigator instructions, if any had been developed In combination with the protocol;

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(x) A listing of all web pages that had early check here termination and the reason for early termination, if applicable;

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