Table 9.

Protocol Deviations for Subjects Completing all 3 Exposures by Center (N = 87)

	URMC	UNC	UCSF
Number of subjects who had at least 1 protocol deviation	12	7	11
Total protocol deviations	18	7	18
Study procedures/assessments performed prior to consent	0	0	0
Obtained consent with outdated/expired consent document	0	0	0
Enrolled subject who did not meet all inclusion/exclusion criteria	3	0	1
Performed study procedure not approved by IRB	0	0	0
Enrolled subject after IRB approval expired	0	0	0
Failed to report adverse event to IRB or sponsor	0	0	0
Failed to follow randomized ozone dosing amount	0	0	0
Failed to perform study procedure as outlined in protocol	14	5	14
Other deviation	1	2	3