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. 2016 May 20;102(17):1342–1347. doi: 10.1136/heartjnl-2014-306775

Table 1.

Number of trials with a p value <0.05 to provide the same level of evidence as PARADIGM-HF on the primary outcome and cardiovascular death

Number of trials with p<0.05 showing efficacy p value required by 1 trial to provide the same strength of evidence PARADIGM-HF p value for primary end point PARADIGM-HF p value for CV death
1 trial 0.05
2 trials* 0.00125* 0.00008 (equivalent to 2–3 trials at p<0.05)
3 trials 0.00003125
4 trials 0.00000078 0.0000004 (equivalent to 4–5 trials at p<0.05)  
5 trials 0.0000000195

Based on the formula (0.025)n×2 where n is the number of trials required (S Pocock personal communication 2015).

*Usual regulatory requirement—2 trials at p<0.05 or 1 trial at p<0.00125.