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It's just that they're strongly appearing to be related and as we go through our review we may reach a level where we believe there's clear causality, but we haven't gotten there yet." So far, in a short period of time, we've gone from an "Early Communication" from the FDA telling doctors and Chantix patients to be on the lookout for abnormal behavior, to a voluntary label change by the company, to a "Public Health Advisory" from the FDA

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"CONFERENCE OF THE PARTIES TO THE WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL" (PDF)