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For the primary composite outcome and secondary hierarchical outcomes, the threshold for two-sided statistical significance was set to 0.0322 (one-sided level 0.00161) using Lan-DeMets alpha spending function, which allows to adjust significance levels as data were reviewed for the interim analysis, reducing the chance of false positive results

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Nse nuk e keni administruar sipas orarit ose e keni harruar, administrojeni menjher nse kan mbetur 3 dit (72 or) ose m shum deri te data e ardhshme e administrimit t planifikuar, dhe m pas merrni dozn tjetr n ditn tuaj t rregullt