Introduction to Randomised Dose
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The study was designed as a double-blind randomised dose-response study of CGMP (with added leucine and tryptophan) in 15 healthy men, receiving 3 different doses of CGMP with an interval of at least 14 days.
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Phase I is a non-randomised dose-escalation study using a Bayesian optimal interval design in which up to 16 patients will be enrolled to evaluate the safest and most efficacious dose for stabilising cholesterol levels.
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There is a need for randomised dose-reduction studies in axSpA and further research to understand the factors that lead to dose-reversion.
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