10 - What does "well-controlled and/or well-designed" in s. 3.1.1 mean?



  • We generally ask for double-blind, randomized trials as reference support for advertising claims. They should be controlled by either placebo or an active comparator, and should be statistically analyzed. In the case of active comparators, it is important to note that the drugs must be compared under the same conditions of use (s. 5.2).


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