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Then, the result for each of these tests is 'POSITIVE' or 'NEGATIVE', affirming presence or identity of the specific pattern in question. " 

In cases like these and the study is submitting under SDTMIG v3.4, should we simply add each of these patterns as sponsor-extended ISTEST/TESTCD terms? Or, would it be acceptable that these remain in LB (MI is also another possible consideration...)?

Our Recommendations and Rationales:

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