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[1] [2] Water fasting may intensify these symptoms and increase dehydration risk, potentially leading to acute kidney injury, particularly if vomiting or diarrhoea occurs without adequate fluid intake

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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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