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483 - In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?
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wrote on 18 Nov 2019, 14:25 last edited by
Yes if by alignment you mean same population type, same endpoint, similar magnitude of effect as the data presented in the APS. Note that the data should be presented with the patient case rather than elsewhere. PAAB 3.1.1.