The assessments included the two primary end points of the study: the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 4 and from baseline to day 30. Prespecified secondary end points included the change in the AUC for the serum sodium concentration in patients with marked hyponatremia, the absolute serum sodium concentration at each visit, the time to normalization of the serum sodium concentration, the percentages of patients with serum sodium concentrations that had normalized at day 4 and day 30, and the categorical serum sodium concentration on day 4 and day 30 (normal value, >135 mmol per liter; mild hyponatremia, 130 to
135 mmol per liter as conservatively extended for the analysis of categorical change; or marked hyponatremia,
The assessments included the two primary end points of the study: the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 4 and from baseline to day 30. Prespecified secondary end points included the change in the AUC for the serum sodium concentration in patients with marked hyponatremia, the absolute serum sodium concentration at each visit, the time to normalization of the serum sodium concentration, the percentages of patients with serum sodium concentrations that had normalized at day 4 and day 30, and the categorical serum sodium concentration on day 4 and day 30 (normal value, >135 mmol per liter; mild hyponatremia, 130 to135 mmol per liter as conservatively extended for the analysis of categorical change; or marked hyponatremia, <130 mmol per liter) for patients with mild or marked hyponatremia at baseline.
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