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Are supplements and nutraceuticals "novel" pharmacological interventions?

We understand there may be interest in studies assessing the neutraceuticals or supplments for the treatment of migraine, but note these are likely to be challenging to conduct with rigor given limitations in the evidence of their efficacy and their variation in content, ingredients, dose, purity, and quality. Applicants proposing to study nutraceuticals or supplements should be attentive to these challenges, and if submitting an LOI or application, provide a strong and defensible rationale for their use and how variations in their content and quality will be managed in the study and in the applicability of research findings.

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