Table 2.

Intervention status of subjects enrolled in the trial.

Treatment	Active	Placebo
Received intervention as allocated	28	28
Withdrew from study	2	2
Lost to follow-up	1	1
Less than 50% of intervention	1	1
Completed trial	24	24
Treatment failures	21	23
Cure rate ITT	3/28 (11%)	1/28 (3.6%)
95% CI	2.2–28.2	0.0–18.34
Cure rate PP	2/24 (12.5%)	1/24 (4%)
95% CI	2.6–32.3	0.1–21.1

ITT: intention-to-treat analysis; CI: confidence interval; PP: per protocol analysis.