Table 1. Adverse Events by Categoryfor Intent-to-treat Subjects

Category / Treatment / AE / FET
p_value
No / Yes
Cardiovascular / Control / 15 / 0 / 1.0000
EPA / 15 / 0
SDA / 14 / 1
Dermatological / Control / 14 / 1 / 1.0000
EPA / 15 / 0
SDA / 14 / 1
Endocrine/ / Control / 14 / 1 / 0.7622
Metabolic / EPA / 13 / 2
SDA / 15 / 0
Gastro- / Control / 12 / 3 / 0.6110
intestinal / EPA / 10 / 5
SDA / 9 / 6
Genitourinary / Control / 14 / 1 / 1.0000
EPA / 13 / 2
SDA / 14 / 1
Neurological / Control / 10 / 5 / 0.2287
EPA / 14 / 1
SDA / 13 / 2
Oral/dental / Control / 15 / 0 / 0.7622
EPA / 14 / 1
SDA / 13 / 2
Other / Control / 10 / 5 / 0.7494
EPA / 12 / 3
SDA / 12 / 3
Respiratory / Control / 12 / 3 / 1.0000
EPA / 12 / 3
SDA / 12 / 3
Trauma / Control / 14 / 1 / 1.0000
EPA / 15 / 0
SDA / 14 / 1
Upper Respira- / Control / 14 / 1 / 1.0000
tory Infection / EPA / 15 / 0
SDA / 15 / 0

Legend:

Data were summarized by category at subject level. Fisher’s Exact (FET) Test was used to compare the counts for the three treatment groups and p-values were generated for each category. All the p-values are greater than 0.05, therefore, there is no significant association between adverse event (i.e., the number of subjects with an adverse event type) and treatments.

Table 2. Adverse Events by Severity for Intent-to-treat Subjects

Severity / N / FET
p_value
Control / EPA / SDA
1 / 17 / 15 / 18 / 0.5727
2 / 5 / 3 / 2
3 / 2 / 2 / 0

Legend

Data were summarized by severity and category at subject level.FET was used to compare the counts for the three treatment groups across categories.The p-valueis greater than 0.05, therefore, there is no significant association between severity and treatment.

Table 3. Baseline and Final Characteristics for Serum Safety Data from Intent-to-treat Subjects

Characteristic / Control / EPA / SDA
Albumin (gm/dL) / Initial / 4.37 ± 0.32 / 4.32 ± 0.21 / 4.47 ± 0.24
Final / 4.45 ± 0.20 / 4.37 ± 0.23 / 4.60 ± 0.30
Adjusted Final / 4.50 / 4.41 / 4.54
Alkaline / Initial / 70.5 ± 25.9 / 73.4 ± 19.3 / 65.8 ± 18.7
Phosphatase (U/L) / Final / 66.9 ± 22.3 / 70.8 ± 21.9 / 67.9 ± 20.3
Adjusted Final / 66.9 / 68.6 / 70.1
BUN (mg/dL) / Initial / 14.3 ± 3.2 / 14.9 ± 3.4 / 13.6 ± 3.8
Final / 14.7 ± 3.2 / 12.7 ± 2.8 / 13.0 ± 2.6
Adjusted Final / 14.5 / 12.3* / 13.9
Bilirubin, Total / Initial / 0.65 ± 0.40 / 0.50 ± 0.21 / 0.55 ± 0.22
(mg/dL) / Final / 0.53 ± 0.33 / 0.48 ± 0.17 / 0.67 ± 0.45
Adjusted Final / 0.49 / 0.56 / 0.63
CO2(mEq/L) / Initial / 29.6 ± 1.5 / 28.2 ± 2.9 / 29.5 ± 2.3
Final / 29.9 ± 2.1 / 28.6 ± 2.7 / 29.6 ± 2.1
Adjusted Final / 29.8 / 28.7 / 29.5
Calcium (mg/dL) / Initial / 9.55 ± 0.32 / 9.45 ± 0.50 / 9.45 ± 0.55
Final / 9.45 ± 0.28 / 9.42 ± 0.59 / 9.62 ± 0.42
Adjusted Final / 9.46 / 9.50 / 9.53
Chloride(mEq/L) / Initial / 103.1 ± 2.1 / 103.8 ± 2.3 / 103.5 ± 1.4
Final / 104.8 ± 2.0 / 105.3 ± 2.1 / 103.8 ± 2.3
Adjusted Final / 104.9 / 105.1 / 103.9
Creatinine Serum / Initial / 0.92 ± 0.14 / 0.79 ± 0.14 / 0.84 ± 0.18
(mg/dL) / Final / 0.89 ± 0.16 / 0.79 ± 0.16 / 0.89 ± 0.19
Adjusted Final / 0.85 / 0.83 / 0.90
Glucose (mg/dL) / Initial / 97.1 ± 11.3 / 95.3 ± 9.8 / 93.1 ± 6.0
Final / 99.8 ± 13.6 / 99.5 ± 6.9 / 98.2 ± 6.7
Adjusted Final / 100.0 / 98.5 / 100.2
Potassium / Initial / 4.63 ± 0.29 / 4.52 ± 0.22 / 4.44 ± 0.31
(mEq/L) / Final / 4.81 ± 0.34 / 4.46 ± 0.17 / 4.53 ± 0.18
Adjusted Final / 4.79 / 4.48* / 4.54
SGOT (U/L) / Initial / 20.5 ± 8.2 / 23.0 ± 10.0 / 20.5 ± 5.6
Final / 22.8 ± 4.8 / 23.8 ± 9.1 / 22.8 ± 6.2
Adjusted Final / 23.2 / 23.3 / 23.4
SGPT (U/L) / Initial / 23.5 ± 9.2 / 27.1 ± 12.2 / 22.3 ± 9.1
Final / 25.5 ± 8.3 / 25.7 ± 12.3 / 24.9 ± 11.1
Adjusted Final / 25.1 / 24.6 / 26.2
Sodium(mEq/L) / Initial / 140.5 ± 1.8 / 139.5 ± 1.0 / 140.2 ± 1.5
Final / 141.6 ± 1.8 / 140.8 ± 1.9 / 140.7 ± 2.3
Adjusted Final / 141.7 / 140.9 / 140.6
Total Protein (gm/dL) / Initial / 7.27 ± 0.34 / 7.13 ± 0.28 / 7.13 ± 0.37
Final / 7.25 ± 0.31 / 7.13 ± 0.30 / 7.24 ± 0.38
Adjusted Final / 7.22 / 7.14 / 7.27
Abs. Basophil / Initial / 0.09 ± 0.04 / 0.07 ± 0.05 / 0.06 ± 0.05
(K/uL) / Final / 0.10 ± 0.04 / 0.07 ± 0.05 / 0.07 ± 0.05
Adjusted Final / 0.09 / 0.06 / 0.08
Abs. Eosinophils / Initial / 0.17 ± 0.10 / 0.17 ± 0.06 / 0.12 ± 0.09
(K/uL) / Final / 0.19 ± 0.14 / 0.22 ± 0.10 / 0.15 ± 0.11
Adjusted Final / 0.17 / 0.21 / 0.18
Abs. Lymphocytes / Initial / 2.10 ± 0.66 / 1.83 ± 0.57 / 1.58 ± 0.41
(K/uL) / Final / 1.91 ± 0.42 / 1.93 ± 0.73 / 1.78 ± 0.57
Adjusted Final / 1.72 / 1.99 / 1.90
Abs. Monocytes / Initial / 0.49 ± 0.10 / 0.44 ± 0.12 / 0.46 ± 0.13
(K/uL) / Final / 0.56 ± 0.15 / 0.44 ± 0.14 / 0.50 ± 0.13
Adjusted Final / 0.55 / 0.44 / 0.51
Abs. Neutrophils / Initial / 3.58 ± 1.05 / 3.47 ± 0.99 / 2.93 ± 0.57
(K/uL) / Final / 3.54 ± 0.78 / 3.45 ± 0.83 / 3.18 ± 0.84
Adjusted Final / 3.45 / 3.42 / 3.29
Basophil (%) / Initial / 1.2 ± 0.4 / 1.2 ± 0.4 / 1.2 ± 0.4
Final / 1.4 ± 0.7 / 1.4 ± 0.5 / 1.0 ± 0.6
Adjusted Final / 1.3 / 1.3 / 1.1
Eosinophils (%) / Initial / 2.7 ± 1.4 / 2.7 ± 1.2 / 2.5 ± 1.8
Final / 3.2 ± 2.0 / 3.5 ± 1.4 / 2.5 ± 1.8
Adjusted Final / 2.9 / 3.4 / 2.8
Lymphocytes (%) / Initial / 32.5 ± 7.5 / 30.8 ± 7.2 / 30.7 ± 4.9
Final / 30.5 ± 6.2 / 31.2 ± 6.3 / 31.5 ± 3.9
Adjusted Final / 29.8 / 32.2 / 31.4
Monocytes (%) / Initial / 8.3 ± 2.8 / 7.6 ± 2.2 / 9.0 ± 2.2
Final / 9.3 ± 3.3 / 7.5 ± 1.8 / 8.6 ± 1.9
Adjusted Final / 9.2 / 7.6 / 8.4
Neutrophils (%) / Initial / 55.3 ± 8.5 / 57.6 ± 8.1 / 57.1 ± 6.8
Final / 56.0 ± 6.9 / 57.0 ± 6.9 / 56.7 ± 5.9
Adjusted Final / 57.2 / 55.9 / 56.6
Hematocrit (%) / Initial / 44.37 ± 3.87 / 43.08 ± 3.46 / 44.45 ± 3.61
Final / 43.11 ± 3.50 / 42.73 ± 3.14 / 44.48 ± 3.91
Adjusted Final / 43.20 / 43.57 / 43.87
Hemoglobin / Initial / 15.02 ± 1.40 / 14.61 ± 1.20 / 15.12 ± 1.34
(gm/dL) / Final / 14.52 ± 1.29 / 14.52 ± 1.14 / 15.33 ± 1.42
Adjusted Final / 14.63 / 14.82 / 15.01
MCH (pg) / Initial / 29.60 ± 1.49 / 29.31 ± 1.49 / 29.90 ± 0.98
Final / 29.87 ± 1.09 / 30.09 ± 1.73 / 30.63 ± 1.08
Adjusted Final / 30.18 / 30.30 / 30.12
MCHC (%) / Initial / 33.81 ± 0.50 / 33.91 ± 0.60 / 34.02 ± 0.66
Final / 33.67 ± 0.61 / 34.00 ± 0.48 / 34.48 ± 1.32
Adjusted Final / 33.90 / 34.01 / 34.25
MCV (fl) / Initial / 87.55 ± 4.09 / 86.41 ± 3.38 / 87.87 ± 2.30
Final / 88.67 ± 2.94 / 88.39 ± 4.33 / 88.83 ± 2.27
Adjusted Final / 89.00 / 89.06 / 87.89
Platelet Count / Initial / 253.4 ± 37.0 / 286.7 ± 69.9 / 253.1 ± 56.2
(K/uL) / Final / 253.2 ± 35.6 / 253.6 ± 65.3 / 241.8 ± 46.4
Adjusted Final / 257.0 / 247.6 / 244.1
RBC (M/uL) / Initial / 5.08 ± 0.52 / 4.99 ± 0.38 / 5.06 ± 0.40
Final / 4.87 ± 0.45 / 4.84 ± 0.39 / 5.01 ± 0.44
Adjusted Final / 4.86 / 4.90 / 4.97
RDW (%) / Initial / 15.05 ± 0.76 / 15.06 ± 1.12 / 14.66 ± 0.78
Final / 15.07 ± 0.77 / 14.80 ± 0.70 / 14.34 ± 1.30
Adjusted Final / 15.04 / 14.78 / 14.41
WBC (K/uL) / Initial / 6.42 ± 1.36 / 5.97 ± 1.24 / 5.13 ± 0.82
Final / 6.28 ± 0.95 / 6.09 ± 1.42 / 5.65 ± 1.42
Adjusted Final / 6.00 / 6.05 / 5.95
Chol/HDL / Initial / 4.55 ± 1.19 / 3.99 ± 1.34 / 3.81 ± 1.27
Final / 4.53 ± 1.85 / 4.03 ± 1.55 / 3.88 ± 1.30
Adjusted Final / 4.18 / 4.12 / 4.07
VLDL (mg/dL) / Initial / 32.0 ± 12.6 / 26.1 ± 16.8 / 18.9 ± 7.2
Final / 28.5 ± 18.6 / 23.2 ± 15.2 / 17.5 ± 6.6
Adjusted Final / 24.2 / 22.2 / 20.5

Summary statistics for initial and final are expressed as mean ± SD (standard deviation). Adjusted Final is the estimate of mean from ANCOVA model after adjustment for the baseline, sex, age and BMI.

* Differs significantly (p-value<0.05) from the Control group.

Abbreviations: blood urea nitrogen (BUN), serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), absolute (Abs.), hematocrit (HCT), hemoglobin (HGB), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, red blood cell count (RBC), red cell distribution width (RDW), white blood cell count with differential (WBC), Total cholesterol (Chol), high density lipoprotein (HDL), very low density lipoprotein (VLDL)