On Day 1 immediately post treatment, the LS Mean (95% CI) percent reduction from pre-treatment for OL was 53.04% (49.37%, 56.71%) for TC+, 49.59% (45.90%, 53.28%) for LCM and 47.1% (43.40%, 50.79%) for MTB. The pair-wise comparison between TC+ and MTB was statistically significant (p-value = 0.0330).
At four hours post-treatment, the percent reduction in OL was 44.06% (39.89%, 48.23%) for TC+, 34.22% (30.03%, 38.41%) for LCM, and 38.37% (34.16%, 42.57%) for MTB. The pair-wise comparison between TC+ and LCM was statistically significant (p-value = 0.0062).
At eight hours post-treatment, the percent reduction in OL was 46.67% (42.18%, 51.57%) for TC+, 22.83% (18.31%, 27.35%) for LCM and 26.19% (21.66%, 30.72%) for MTB. The differences between TC+ and MTB, and TC+ and LCM, were significant (p-value < 0.0001, for each pair-wise comparison).
For OL outcomes on Day 8, the TC+ treatment group exhibited the lowest value throughout the study visit. Statistically significant differences were observed between TC+ and LCM, and TC+ and MTB, at each time point: immediately, four hours and eight hours following product use.
Values are included below.
The reported safety events were mild in severity and were unrelated to test product use.