Statistical Analysis

• Prespecified and finalized with the FDA prior to randomization code-break

• Efficacy population– 469 of 470 randomized patients

  • Excluded 1 placebo patient who did not receive study drug

• Analysis of non-completers (primary endpoint)

  • Death, transplant, worsening disease: worst rank
  • Adverse effects: last value carried forward

• Nonparametric analysis of primary endpoint

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