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N-Of-1 Trials

Meaning

N-of-1 trials, or single-subject trials, are rigorous, randomized, controlled clinical studies where the entire study population consists of a single individual, allowing for highly personalized therapeutic assessment. In this design, the patient receives both the active intervention and a placebo (or comparator treatment) multiple times in a randomized, blinded sequence. This methodology provides the highest level of evidence to determine the optimal therapeutic strategy for that specific individual, especially valuable in hormonal health where inter-individual variability in response is high.