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Beyond GI effects, clinical trials documented dose-dependent heart rate increases that peaked at approximately 24 weeks and then declined

In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed, section 1899B(e)(2)(B) of the Act permits the Secretary to specify a measure that is not so endorsed, as long as due consideration is given to the measures that have been endorsed or adopted by a consensus organization identified by the Secretary

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doi:10.1074/jbc.M706204200 Massudi H, Grant R, Braidy N, Guest J, Farnsworth B, Guillemin GJ