Table 3. Assessment of safety-related biochemical parameters (safety population).

Parameter	Control (N=45)			Sham Control (N=43)			Biofield Energy Therapy (N=44)
	Day 0 (Mean ± SD)	Day 90 (Mean ± SD)	Day 180 (Mean ± SD)	Day 0 (Mean ± SD)	Day 90 (Mean ± SD)	Day 180 (Mean ± SD)	Day 0 (Mean ± SD)	Day 90 (Mean ± SD)	Day 180 (Mean ± SD)
Kidney Biomarkers
BUN (mg/dL)	7.91 ± 2.50	8.17 ± 2.30	8.14 ± 2.34	8.69 ± 2.19	8.03 ± 1.65	9.12 ± 2.79	7.50 ± 2.25	7.28 ± 2.15	8.85 ± 2.65
Creatinine (mg/dL)	0.90 ± 0.20	0.80 ± 0.17	0.78 ± 0.16	0.92 ± 0.16	0.76 ± 0.14	0.82 ± 0.16	0.85 ± 0.17	0.73 ± 0.13	0.78 ± 0.15
Uric acid (mg/dL)	4.57 ± 1.34	4.51 ± 1.18	4.54 ± 1.38	4.86 ± 1.08	4.70 ± 1.06	4.76 ± 0.95	4.55 ± 1.00	4.62 ± 1.08	4.89 ± 0.98
Urea (mg/dL)	16.92 ± 5.36	17.48 ± 4.92	17.47 ± 5.01	18.59 ± 4.68	17.19 ± 3.54	17.43 ± 5.01	16.04 ± 4.82	15.59 ± 4.61	18.94 ± 5.66
Heart Biomarkers
LDH (U/L)	190.85 ± 30.07	189.12 ± 34.87	187.24 ± 37.95	190.75 ± 32.49	184.95 ± 36.19	175.10 ± 27.59	196.65 ± 30.35	187.29 ± 36.40	188.69 ± 46.74
CK-MB (U/L)	32.24 ± 10.47	34.99 ± 10.61	35.53 ± 14.71	28.02 ± 7.52	29.65 ± 9.60	25.00 ± 7.61	30.60 ± 7.91	31.73 ± 8.42	27.59 ± 6.87
Liver Biomarkers
ALP (U/L)	74.50 ± 19.70	83.28 ± 21.64	78.43 ± 21.27	74.34 ± 18.26	77.67 ± 19.50	72.97 ± 21.40	82.09 ± 22.90	78.94 ± 25.57	81.80 ± 20.80
SGPT (U/L)	24.06 ± 13.17	28.36 ± 17.63	26.96 ± 24.04	20.18 ± 9.61	24.47 ± 15.06	21.15 ± 11.73	23.71 ± 12.28	26.40 ± 12.06	29.66 ± 45.38
SGOT (U/L)	24.20 ± 11.74	29.68 ± 18.27	28.52 ± 24.21	21.42 ± 7.69	22.12 ± 8.43	20.06 ± 8.00	24.41 ± 7.98	25.67 ± 10.31	30.45 ± 50.03
Bilirubin (mg/dL)	0.62 ± 0.31	0.48 ± 0.31	0.50 ± 0.26	0.63 ± 0.27	0.42 ± 0.25	0.48 ± 0.22	0.58 ± 0.24	0.39 ± 0.16	0.50 ± 0.28
Lipid Profile
Total cholesterol (mg/dL)	178.54 ± 34.01	171.00 ± 20.54	168.44 ± 24.12	189.92 ± 33.40	185.35 ± 28.22	184.15 ± 30.65	175.41 ± 30.69	172.22 ± 34.67	177.80 ± 41.14
LDL (mg/dL)	111.57 ± 29.82	101.44 ± 21.33	99.14 ± 25.48	119.67 ± 29.65	111.21 ± 24.20	112.51 ± 28.26	105.80 ± 25.10	99.88 ± 34.27	106.01 ± 36.03
VLDL (mg/dL)	20.30 ± 8.77	21.67 ± 11.15	2.40 ± 9.11	22.00 ± 7.85	23.04 ± 10.67	21.89 ± 10.67	22.59 ± 17.18	25.35 ± 14.55	26.99 ± 16.76
HDL (mg/dL)	46.67 ± 16.98	47.90 ± 17.01	47.41 ± 18.28	48.26 ± 13.59	51.10 ± 12.52	48.84 ± 13.11	47.03 ± 11.83	47.00 ± 9.97	44.80 ± 11.48
Triglyceride (mg/dL)	101.50 ± 43.86	108.33 ± 55.73	109.43 ± 53.36	109.99 ± 39.26	115.22 ± 53.35	114.02 ± 56.12	112.94 ± 85.89	126.73 ± 72.73	134.97 ± 83.81
Oxidized LDL (pg/mL)	2374.29 ± 449.52	1594.60 ± 763.72	1112.66 ± 523.86	1731.95 ± 719.22	1630.13 ± 617.44	1306.09 ± 609.95	1443.44 ± 561.08	1954.44 ± 727.38	1344.30 ± 691.52
Metabolic Biomarkers
HbA1c (%)	5.43 ± 0.28	5.46 ± 0.31	5.29 ± 0.27	5.47 ± 0.53	5.46 ± 0.46	5.42 ± 0.45	5.37 ± 0.33	5.41 ± 0.32	5.35 ± 0.32
Insulin (mU/L)	10.00 ± 6.67	15.04 ± 14.79	8.54 ± 4.73	9.34 ± 5.80	15.52 ± 13.98	13.53 ± 18.03	9.83 ± 4.91	12.05 ± 10.20	13.06 ± 12.59
HOMA-IR	1.93 ± 1.33	2.96 ± 3.71	1.67 ± 0.95	1.90 ± 1.30	3.13 ± 3.19	2.94 ± 4.83	1.89 ± 1.03	2.29 ± 1.95	2.70 ± 2.94
HOMA-β (%)	179.81 ± 430.46	1998.08 ± 18561.30	219.23 ± 184.40	225.15 ± 166.88	456.66 ± 528.38	339.64 ± 397.01	277.34 ± 182.60	374.35 ± 441.63	209.89 ± 526.84
Glucose (mg/dL)	80.06 ± 6.47	76.98 ± 10.90	78.06 ± 6.87	80.57 ± 11.55	77.21 ± 11.10	79.95 ± 10.32	78.56 ± 7.28	76.36 ± 6.46	81.20 ± 8.76
Others Biomarkers
Albumin (g/dL)	4.60 ± 0.31	4.41 ± 0.27	4.39 ± 0.32	4.70 ± 0.32	4.50 ± 0.30	4.43 ± 0.29	4.82 ± 0.42	4.55 ± 0.40	4.53 ± 0.45
Total protein (g/dL)	7.72 ± 0.47	7.72 ± 0.36	7.58 ± 0.5	7.82 ± 0.39	7.78 ± 0.41	7.52 ± 0.40	7.99 ± 0.59	7.76 ± 0.47	7.69 ± 0.45

BUN: Blood urea nitrogen, LDH: Lactate dehydrogenase, CK-MB: creatine kinase-myocardial band, ALP: Alkaline phosphatase, SGPT: Serum glutamic-pyruvic transaminase, SGOT: Serum glutamic-oxaloacetic transaminase, LDL: Low density lipoprotein, VLDL: Very low density lipoprotein, HDL: High density lipoprotein, HbA1c: Hemoglobin A1c (glycated haemoglobin), HOMA-IR: Homeostatic model assessment of insulin resistance, HOMA-β: Homeostasis model assessment of β-cell function