Primary clinical outcome over 2 years: non-inferiority of effect of AZA vs. IFN, represented as annualized relapse rate ratio (RR<sub>AZA/IFN</sub>) compared with the pre-established non-inferiority margin M ( = 1.23) and with a margin M<sub>1</sub> = 1.0.
- Luca Massacesi (662301)
- Irene Tramacere (662302)
- Salvatore Amoroso (174295)
- Mario A. Battaglia (662303)
- Maria Donata Benedetti (662304)
- Graziella Filippini (662305)
- Loredana La Mantia (662306)
- Anna Repice (662307)
- Alessandra Solari (397759)
- Gioacchino Tedeschi (662308)
- Clara Milanese (662309)
Publication date
November 2014
DOIAbstract
<p>One-sided 99% CI of the 0.67 ratio (upper-limit, U<sub>L</sub> = 1.12), represents an effect of AZA vs. IFNs equivalent to at least 75% of the effect of IFNs vs. Placebo. One-sided 95% CI of the same ratio (U<sub>L</sub> = 0.96), represents an effect of AZA vs. IFNs equivalent to at least 100% of the effect of IFNs vs. Placebo. Abbreviations: AZA, azathioprine; IFN, interferon; PY, person-years; RR, rate ratio.</p
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