The first dose was infused over at least 30 min; if there was no

The first dose was infused over at least 30 min; if there was no reaction

encountered with administration of the first dose, each subsequent dose was administered over at least 15 min (or per local hospital pharmacy policy) in a maximum of 100 mL 0.9% sodium chloride. Monitoring included assessment of vital signs at baseline and every 15 min during the infusion and 15 min postinfusion. The primary outcome was changed in 6MWT distances from baseline to 12 weeks. The primary outcome was chosen to assess whether iron repletion would improve functional impairment, which is of high importance in geriatric populations. Secondary outcomes included the change from baseline to 12 weeks for hemoglobin measurement, and quantification of the impact of anemia treatment on functional and self-report outcome measures as assessed by the Geriatric Evaluation Panel (GEP), consisting of the following: – Cognitive function based on the Trail JAK inhibitor Making Test and four CogState® cognitive subtests; For reporting purposes, the secondary outcomes based on the GEP are summarized as follows: 1. Physical function: 4-m walk speed obtained as a component of the frailty index (see below); The GEP was administered to each subject during the screening

period and at weeks 12 and 24. selleck chemicals The 6MWT was additionally measured at weeks 6 and 18. Safety outcomes included all clinical and reportable events. We calculated that a sample size of 84 subjects, with 42 subjects per group, would provide 84% power to detect a clinical significant difference of 50 m in change of distances (the primary outcome) between the immediate intervention group and the wait list control group, with a type I error rate of 0.05. This calculation was based Methisazone on a two-sample t-test by assuming a standard deviation of 115 m for the baseline 6MWT distance in both groups and correlations of 0.7 and 0.9 between distances at baseline and 12 weeks for the immediate intervention and wait list control groups, respectively. This sample size

also took into account a 10% missing data rate. Baseline characteristics were summarized using descriptive statistics, with categorical data presented as percentages and continuous data presented as the mean plus/minus standard deviation. Differences between treatment groups were assessed using a chi-square test or Fisher’s exact test (for small frequencies) for categorical data, and a t-test or Wilcoxon test (for non-normal data) for continuous data. The primary endpoint of change in 6MWT distances from baseline to 12 weeks between the two groups was tested using the two-sample t-test. All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The impact of missing data in the primary analysis was examined by sensitivity analyses based on best and worst case scenarios for imputing the missing change.

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