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The applicant did not submit sufficient data on consumer perception or behavior change related to the proposed modified risk claim and this specific product

THE DIAGNOSIS The EKG showed ST-segment elevation in the inferolateral leads, consistent with an acute myocardial infarction (AMI) ( FIGURE 1 )

J Headache Pain 23(1):34 Waliszewska-Pros M, Montisano DA, Antolak M, Bighiani F, Cammarota F, Cetta I et al (2024) The impact of primary headaches on disability outcomes: a literature review and meta-analysis to inform future iterations of the global burden of disease study

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This can cause severe side effects