Table 3.

Selected Laboratory, Vital Sign, Weight, and ECG Results at the LOCF Final Evaluation (safety population) Using Open-Label Baseline

Variable, Units	n	Baseline Meana	Mean Change From Baselineb
Laboratory Assessments
Creatinine, mg/dL	1,188	0.804	−0.001
Alkaline phosphatase, U/L	1,185	75.6	1.6†
AST/SGOT, U/L	1,182	22.9	0.5
ALT/SGPT, U/L	1,185	24.6	0.7
GGT, U/L	1,185	29.4	6.0†
Total bilirubin, mg/dL	1,187	0.475	−0.042†
Total cholesterol/lipids, fasting, mg/dL	979	211.51	4.90†
HDL cholesterol, fasting, mg/dL	977	54.31	1.95†
LDL cholesterol, fasting, mg/dL	966	130.63	0.66
Triglycerides, fasting, mg/dL	979	134.46	10.48†
Vital Signs and Weight
Supine pulse rate, bpm	1,353	70.53	3.26†
Systolic BP, supine, mm Hg	1,353	121.60	2.58†
Diastolic BP, supine, mm Hg	1,353	77.54	1.20†
Weight, kg	1,353	79.69	1.25†
ECG
Heart rate, bpm	1,161	70.4	3.47†
PR interval, ms	1,161	156.04	−3.17†
QRS interval, ms	1,161	85.19	0.78†
QT interval, ms	1,161	380.76	−5.17†
QTcB interval, ms	1,161	409.60	4.24†
QTcF interval, msc	1,161	399.49	0.97*
QTcN interval, ms	1,161	400.31	−6.43†
RR interval, ms	1,161	872.09	−40.57†

^aFor this study, the baseline used for comparison was the average of all values at the day 56 evaluation (or final evaluation) of the short-term study.

^bAll statistics were evaluated using data with nonmissing baseline values.

^cQTcF intervals were calculated by central ECG reader.

^†P < .001 vs baseline mean.

^*P < .05 vs baseline mean.

Abbreviations: ALT/SGPT = alanine aminotransferase/serum glutamic-pyruvic transaminase, AST/SGOT = aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, BP = blood pressure, bpm = beats per minute, ECG = electrocardiogram, GGT = γ-glutamyl transpeptidase, HDL = high-density lipoprotein, LDL = low-density lipoprotein, LOCF = last observation carried forward, QTcB = QT correction using the Bazett formula, QTcF = QT correction using the Fridericia formula, QTcN = QT correction based on the population correction factor.