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The sample size was calculated to provide at least 90% power for showing bioequivalence between the 1G and 2G formulations for all three dose groups, based on the standard acceptance limits (0.80001.2500) to ensure sufficient power to confirm bioequivalence in accordance with the EMA, FDA and PMDA guidelines

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Increased CRP levels were associated with a significantly lower increase in serum iron, while variations in ferritin levels also showed a notable impact

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