Table 2.

Study Outcomes.

Outcome	Measure	Efficacy population			ITT population
		Metadoxine	Placebo	P	Metadoxine	Placebo	P
Steatosis grade	Mean change ± SD (N)	−0.76 ± 0.92 (46)	0.00 ± 0.76 (36)	<0.001a	−0.08 ± 1.12 (75)	0.37 ± 0.76 (59)	0.006a
	Improved patients, n/N (% [95% CI])	34/46 (73.9% [58.9–85.7])	9/36 (25.0% [12.1–42.2])	<0.001b	34/75 (45.3% [33.8–57.3])	9/59 (15.3% [7.2–27.0])	<0.001b
Necro-inflammation grade	Mean change ± SD (N)	−0.71 ± 0.76 (34)	−0.50 ± 0.67 (32)	0.249a	0.09 ± 0.95 (75)	0.10 ± 0.87 (59)	0.965a
	Improved patients, n/N (% [95% CI])	20/34 (58.8% [40.7 + 75.4])	15/32 (46.9% [29.1–65.3])	0.331b	20/75 (26.7% [17.1–38.1])	15/59 (25.4% [15.0–38.4])	0.871b
Fibrosis stage	Mean change ± SD (N)	−0.24 ± 0.86 (34)	−0.16 ± 0.72 (32)	0.687a	0.38 ± 0.84 (75)	0.36 ± 0.78 (59)	0.875a
	Improved patients, n/N (% [95% CI])	12/34 (35.3% [19.7–53.5])	7/32 (21.9% [9.3–40.0])	0.229b	12/75 (16.0% [8.6–26.3])	7/59 (11.9% [4.9–22.9])	0.496b
ALT, U/L	Median change [RIQ]; N	−19.0 [−58.0, +3.0]; 61	−20.5 [−72.3, +0.5]; 44	0.436c
AST, U/L	Median change [RIQ]; N	−4 [−27, +8]; 59	−19 [−31, +0]; 43	0.069c

n: patients with event; N: observed patients. AST, aspartate aminotransferase; ALT, alanine aminotransferase; RIQ, Range interquartile (25th, 75th percentile).

^aIndependent-samples t-test.

^bChi-square test.

^cMann–Whitney U-test.