Table 2. Exception From Informed Consent Acceptance by Participant Clinical Baseline Characteristics and Outcomes (N_Total = 74).

Patient Outcomes	General trial inclusion		Personal EFIC enrollment		General EFIC enrollment
	NAgree (% Agree)	p	NAgree (% Agree)	p	NAgree (% Agree)	p
Overall	61 (82)		57 (77)		54 (73)
Initial injury severity based on GCS score x
Severe	8 (89)	0.457a	9 (100)	0.040a	9 (100)	0.034a
Moderate-Severe	35 (83)		33 (79)		31 (74)
Moderate	18 (78)		15 (65)		14 (61)
Initial injury severity based on ISS score y
1-15: Less severe	10 (83)	1.000b,c	11 (92)	0.274b	9 (75)	1.000b,c
16-75: More severe	51 (82)		46 (74)		45 (73)
6-month outcome based on GOS-E score* z
1-2: Death/Vegetative state	4 (100)	0.263a	2 (50)	0.066a	3 (75)	0.575a
3-4: Severe disability	13 (68)		13 (68)		13 (68)
5-6: Moderate disability	22 (81)		21 (78)		19 (70)
7-8: Good recovery	21 (91)		20 (87)		18 (78)
6-month outcome relative to initial injury severity*
Favorable	38 (86)	0.251d	39 (89)	0.003d	35 (80)	0.101d
Unfavorable	22 (76)		17 (59)		18 (62)

EFIC= exception from informed consent.

^aSimple logistic regression

^bFisher's exact test

^cTwo-sided p value for Fisher exact test is 1.000 due to rounding and corresponds to the probability of observing the given difference or any more extreme differences with the same fixed marginal

^dChi-Square test

^*6-month GOS-E score not available for 1 participant, n=73

^xIndex Glasgow Coma Scale (GCS), defined as the highest reliable GCS score documented prior to randomization, ranges from 3 to 15. Lower scores indicate lower level of consciousness. The overall GCS score is the sum of scores given for motor (range 1-6), verbal, and eye-opening components.

^yThe Injury Severity Score ranges from 0 to 75. Higher scores suggest greater injury severity.

^zAn Extended Glasgow Outcome Scale (GOS-E) score of 1 indicates death, and 2, vegetative state; 3 or 4 severe disability; 5 or 6 moderate disability; and 7 or 8 good recovery.