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These events occurred mainly during the early phase of treatment when the dose was being titrated up
It must not be administered, consumed, compounded for administration, used for self-experimentation, or represented as suitable for the diagnosis, treatment, mitigation, cure, or prevention of any condition
However, there are some exceptions that should be considered as well
What the authors are really pushing for is a validation framework built on biological relevance and mechanistic fit, not just concordance with animal data that is itself variable
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