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Non-inferiority will be claimed if the upper bound of the 2-sided Cochran-Mantel-Haenszel (CMH) Score 95% confidence interval (CI) for the treatment difference (Test Control) is less than 50% of the observed Control rate
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Stop immediately if severe symptoms occur, such as breathing difficulty, sudden chest pain, severe rash, jaundice, or syncope, and seek emergency care
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