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Summary of study design: Schedule and size: Outcomes: Critiques of the study design: Operational and technical challenges: Overall, while the design of the phase 1 study for CT-388 is within standard protocols for new therapeutic agents, certain details of the design and operational aspects would benefit from further clarification
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[2] Galloway SDR, et al, 2004: Effect of 2 weeks supplementation with L-Carnitine-L-Tartrate on plasma ammonia response to exercise
A power analysis ( = 0.05 and power = 0.90), based on data where a difference would be significant if the weight loss were 1 kg more than that in CT group with an expected standard deviation of 0.75, indicated that 13 patients would be needed in each group to detect significant difference [18]
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