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    3 - If there are more than two studies that show the same outcome (e.g.: Improved BP reduction Vs a competing ARB) then do we still ask for disclosure of study parameters? Code s5.11 says this should not be required.

    Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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    • Jennifer Carroll
      Jennifer Carroll last edited by

      Code s5.11 goes on to say that 'In no circumstances would extrapolation of the claim beyond the actual study be acceptable'. Often, if one does not specify the population (e.g.: men in a cholesterol agent comparison) then the reader might extrapolate the study results beyond the evaluated population. This would be true even if you had 50 studies showing the same result. Important information such as this should not be put in mice-type.

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