Table 4.

Safety analyses of TJ001.

Safety parameters	Period	Group				P*	(P inter)
		Placebo group (N = 55)		TJ001 group (N = 57)
		Mean ± S.D.	(P intra)	Mean ± S.D.	(P intra)
Blood pressure
Systolic, mmHg	Baseline	123.0 ± 13.9	0.5360	122.7 ± 14.6	0.9712	0.9175	0.3607
	week 4	122.9 ± 12.0		123.3 ± 11.7		0.8620
	week 8	123.9 ± 10.6		125.9 ± 11.4		0.3451
	week 12	124.1 ± 12.0		122.6 ± 11.6		0.5248
	ANOVA	visit X group interaction: P = 0.4121
Diastolic, mmHg	Baseline	77.8 ± 10.8	0.9167	76.6 ± 9.20	0.4862	0.5433	0.7461
	week 4	76.2 ± 9.00		77.1 ± 8.10		0.5852
	week 8	79.7 ± 16.20		78.8 ± 8.20		0.6966
	week 12	77.9 ± 9.20		77.5 ± 7.60		0.7933
	ANOVA	visit X group interaction: P = 0.75
Pulse, bpm	Baseline	76.9 ± 9.30	0.0058	75.3 ± 7.40	0.7718	0.3072	0.0184
	week 4	76.3 ± 7.70		76.3 ± 8.00		0.9851
	week 8	75.5 ± 7.70		76.9 ± 7.60		0.3108
	week 12	73.6 ± 7.20		75.6 ± 8.50		0.1743
	ANOVA	visit X group interaction: P = 0.0475
AST, IU/L	Baseline	24.1 ± 11.0	0.0315	27.9 ± 16.2	0.0003	0.1505	0.0544
	week 12	22 ± 8.80		21.9 ± 12.3		0.9798
ALT, IU/L	Baseline	30.2 ± 23.5	0.1236	28.9 ± 18.9	0.0038	0.7464	0.3573
	week 12	27.3 ± 21.7		22.1 ± 13.5		0.1327
BUN, mg/dL	Baseline	13.4 ± 2.90	0.1252	14.5 ± 10.4	0.2556	0.4616	0.7000
	week 12	12.8 ± 2.60		12.7 ± 4.10		0.8953
Creatinine, mg/dL	Baseline	0.83 ± 0.17	0.3766	0.78 ± 0.18	0.6834	0.1547	0.3731
	week 12	0.85 ± 0.19		0.79 ± 0.19		0.0721

P*: A P value for between-group comparison at each visit and visit X group interaction using ANOVA.

(P _intra): A P value for within-group comparison between baseline and 5th visit by paired t-test.

(P _inter): A P value for between-group comparison after 12-week treatment using ANCOVA (baseline as covariate).

P < 0.05 were considered statistically significant.