Table 3.

Primary outcome (treatment success) - intention to treat and exploratory analyses

Outcome	Intervention group (%)	Control group (%)	Risk difference (%) (95% confidence interval)a	P
Treatment success/Intention to treat analysis	1,606/2,107 (76.2)	1,402/1,984 (70.7)	5.6 (−1.2, 12.3)	0.107
Treatment success/Exploratory analysis	1,051/1,294 (81.2)	1,402/1,984 (70.7)	10.6 (3.7, 17.5)	0.003

The estimated intra-cluster correlation co-efficient for our study for the primary outcome was 0.033. This is very close to the intra-cluster correlation co-efficient assumed in the sample size calculation (0.03). ^aEstimate from generalized linear model.