Any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment. Assessed as number and percent of patients with adverse events, compared across treatment and Placebo groups .

Neurologic systems, including testing of patellar reflex using rubber mallet. Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

AUC (0-inf)

Derived from centrally-overread 12-lead ECGs, measured in triplicate, based on Holter monitoring. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Number of patients with clinically significant changes from Baseline in Blood Urea Nitrogen (BUN); Creatinine; Glucose (fasting); Magnesium; Cholesterol; Calcium; Uric Acid; C-Reactive Protein; Total Bilirubin; Direct Bilirubin; Phosphate; and Triglycerides, compared across treatment and Placebo groups. All tests measured in mg/dL.

Percentage of patients with clinically significant changes from Baseline in Blood Urea Nitrogen (BUN); Creatinine; Glucose (fasting); Magnesium; Cholesterol; Calcium; Uric Acid; C-Reactive Protein; Total Bilirubin; Direct Bilirubin; Phosphate; and Triglycerides, compared across treatment and Placebo groups. All tests measured in mg/dL.

Number of patients with clinically significant changes from Baseline in albumin, globulin, and total protein, compared across treatment and Placebo groups. All tests measured in g/dL.

Percentage of patients with clinically significant changes from Baseline in albumin, globulin, and total protein, compared across treatment and Placebo groups. All tests measured in g/dL.

Number of patients with clinically significant changes from Baseline in Potassium, Sodium, Chloride, and Carbon Dioxide (bicarbonate), compared across treatment and Placebo groups. All tests measured in mmol/L.

Percentage of patients with clinically significant changes from Baseline in Potassium, Sodium, Chloride, and Carbon Dioxide (bicarbonate), compared across treatment and Placebo groups. All tests measured in mmol/L.

Number of patients with clinically significant changes from Baseline in Creatine Kinase muscle/brain (MB) fraction, compared across treatment and Placebo groups. All tests measured in ng/mL.

Percentage of patients with clinically significant changes from Baseline in Creatine Kinase muscle/brain (MB) fraction, compared across treatment and Placebo groups. All tests measured in ng/mL.

Number of patients with clinically significant changes from Baseline in Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT), Alkaline phosphatase, Creatine kinase, and Amylase,compared across treatment and Placebo groups. All tests measured in U/L.

Percentage of patients with clinically significant changes from Baseline in Gamma Glutamyl Transferase, Lactate dehydrogenase, Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT), Alkaline phosphatase, Creatine kinase, and Amylase,compared across treatment and Placebo groups. All tests measured in U/L.

Number of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.

Percentage of patients with clinically significant changes from Baseline in Red Blood Cell count, compared across treatment and Placebo groups. All tests measured in Millions/microL.

Number of patients with clinically significant changes from Baseline in Platelet count and White Blood Cell count, compared across treatment and Placebo groups. All tests measured in Thousands/microL.

Percentage of patients with clinically significant changes from Baseline in Platelet count and White Blood Cell count, compared across treatment and Placebo groups. All tests measured in Thousands/microL.

Number of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.

Percentage of patients with clinically significant changes from Baseline in hematocrit and reticulocytes, compared across treatment and Placebo groups. All tests measured in %.

Number of patients with clinically significant changes from Baseline in Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils, compared across treatment and Placebo groups. All tests measured in cells/microL.

Percentage of patients with clinically significant changes from Baseline in Absolute Neutrophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Eosinophils, and Absolute Basophils, compared across treatment and Placebo groups. All tests measured in cells/microL.

Number of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.

Percentage of patients with clinically significant changes from Baseline in Mean corpuscular hemoglobin, compared across treatment and Placebo groups. All tests measured in pg.

Number of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.

Percentage of patients with clinically significant changes from Baseline in fibrinogen (mg/dL), compared across treatment and Placebo groups.

Number of patients with clinically significant changes from Baseline time, Activated partial thromboplastin time, Thrombin time compared across treatment and Placebo groups. All tests measured in seconds (sec).

Percentage of patients with clinically significant changes from Baseline time, Activated partial thromboplastin time, Thrombin time compared across treatment and Placebo groups. All tests measured in seconds (sec).

Assessed by Investigator, based on education, training, and experience, using stethoscope, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Otolaryngologic head, eye, ear, nose, and throat exam, based on Investigator observation, based on experience, education, and training. Visual assessment of clinical appearance. Ear examined using a flashlight. Throat examined using a tongue depressor. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

12-lead; Number of patients with clinically significant changes from Baseline in Electrocardiogram (ECG) measures of Heart Rate (beats per minute - bpm). Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms"

12-lead. Number of patients with changes from Baseline in PR Interval (ms); RR Intermal (ms); QRS Interval (ms); QT Interval (ms); QTcF Interval (ms); and QTcB Interval (ms)

Oral temperature, using oral thermometer. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Physical signs and symptoms assessed by Investigator observation, based on experience, education, and training. May include observation of obesity or dermatologic conditions. Assessed by Investigator as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Respiratory, measured in breaths per minute (bpm) Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Gastrointestinal signs and symptoms. May include evaluation of normal bowel movements or abdominal pain. Assessed by Investigator, based on education, experience, and training, as "Normal" or "Abnormal - Clinical Symptoms" or "Abnormal - No Clinical Symptoms". Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Body Weight measured in kg using scale. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Height (cm) measured using ruler attached to weighing scale.

Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time

Cmax - Maximum Concentration of drug substance in blood plasma

tmax - Time to Maximum Concentration of drug substance in blood plasma

Time to metabolism of 1/2 of dose (eg, half-life) of drug substance in blood plasma

Oral Clearance of the drug substance (CL/F)

V2/F

pulse rate measured in beats per minute (bpm). Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Sitting diastolic and systolic blood pressure, measured by Karotkoff Cuff in mmHg. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Respiratory rate, measured in breaths per minute. Assessed as number and percent of patients with clinically significant changes from Baseline, compared across treatment and Placebo groups.

Number and percent of patients with clinically significant changes from Baseline in Free T3 (pg/mL), compared across treatment and Placebo groups.

Number and percent of patients with clinically significant changes from Baseline in Free T4 (ng/dL), compared across treatment and Placebo groups.

Number and percent of patients with clinically significant changes from Baseline in TSH (mIU/L), compared across treatment and Placebo groups.

Number and percent of patients with clinically significant changes from Baseline in Urobilinogen (eu/dL), compared across treatment and Placebo groups.

Number and percent of patients with clinically significant changes from Baseline in Red Blood Cell (RBC), Epithelial Cells, Bacteria, Casts, and White Blood Cell (WBC) counts, compared across treatment and Placebo groups. All units measured as /lpf.