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The primary efficacy population was ITT.
The primary efficacy population will be analysed at endpoint for composite score.
Serious bleeding events by study day in the primary efficacy population are displayed in Table 5.
The predefined primary analysis population were patients who received any amount of randomized therapy (primary efficacy population) with combined alternative therapy and standard therapy arms.
The results will be analysed using an intention-to-treat analysis including the full set of all randomised patients (primary efficacy population).
The primary efficacy population included all residents with at least one post-baseline assessment, using the last observation carried forward procedure to account for missing values.
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The intent-to-treat (ITT) Population (the primary efficacy analysis population) included any randomized patients with exposure to study drug (ferumoxytol or placebo) by randomized treatment assignment.
The primary efficacy analysis population was the per-protocol (PP) population, which included all randomized patients who had measurements of the respective end point both at baseline and week 54 and did not have any major protocol violations.
A total of 4036 patients are required in the intent-to-treat (ITT) population (randomisation of 2018 patients per treatment arm) in order to have at least 2906 patients in the primary efficacy analysis population, assuming 80%% of patients in the ITT population have an ACT score of <20 at baseline and a 10%% dropout rate over the first 6-month period.
The primary efficacy analysis population was the per-protocol set (PPS) population.
The FAS was the primary efficacy analysis population.
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