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Table 1 Fixed and constant parameter values for the interim analysis simulations

From: Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study

Description

Constant factors

Factors varied

Interim sample size

n = 50

 

Minimum required sample size

n = 600

 

Number of simulations

1000

 

Between-person SD

σb = 10 mmHg

 

Within person SD

 

σe = 9, 10 mmHg

Overall mean SBP (mmHg)

μ = 140 mmHg

 

Single treatment-by-ethnic interaction (mmHg)

 

δ = 3, 4 mmHg

Period effect (mmHg)

πj = 0 mmHg, j

 

Power to detect a single ethnic by treatment interaction at 5% significance level (%)

 

1 − β = 0.1,0.2