Randomisation and Statistical Analysis
Sample size assumptions compare a 15% control recurrence rate with a 2.5% expected intervention recurrence rate. Primary efficacy analysis follows intention-to-treat, with per-protocol analysis used for robustness.
2 sources - 10 claims
Sample size assumptions compare a 15% control recurrence rate with a 2.5% expected intervention recurrence rate. Primary efficacy analysis follows intention-to-treat, with per-protocol analysis used for robustness.