Trial Outcomes & Findings for GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen (NCT NCT02818582)

GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.

Mean change from baseline in alanine transaminase (ALT) value at day 1

Mean change from baseline in alanine transaminase (ALT) value at day 2

Mean change from baseline in alanine transaminase (ALT) value at day 3

Mean change from baseline in alanine transaminase (ALT) value at day 4

Mean change from baseline in alanine transaminase (ALT) value at day 5

Mean change from baseline in alanine transaminase (ALT) value at day 8

Mean change from baseline in alanine transaminase (ALT) value at day 11

Mean change from baseline in alanine transaminase (ALT) value at day 16

Mean change from baseline in alanine transaminase (ALT) value at at day 24

Mean change from baseline in alanine transaminase (ALT) value at at day 28

Mean change from baseline in alanine transaminase (ALT) value at week 8

Mean change from baseline in alanine transaminase (ALT) Value at week 12

Mean change from baseline in alanine transaminase (ALT) value at week 16

Mean change from baseline in alanine transaminase (ALT) value at week 20

Mean change from baseline in alanine transaminase (ALT) value at week 24

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24

Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20

Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24

Mean change from baseline in aspartate transaminase (AST) Value at day 1

Mean change from baseline in aspartate transaminase (AST) Value at day 2

Mean change from baseline in aspartate transaminase (AST) value at day 3

Mean change from baseline in aspartate transaminase (AST) value at day 4

Mean change from baseline in aspartate transaminase (AST) value at day 5

Mean change from baseline in aspartate transaminase (AST) value at day 8

Mean change from baseline in aspartate transaminase (AST) value at day 11

Mean change from baseline in aspartate transaminase (AST) value at day 16

Mean change from baseline in aspartate transaminase (AST) value at day 24

Mean change from baseline in aspartate transaminase (AST) value at day 28

Mean change from baseline in aspartate transaminase (AST) value at week 8

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16

Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20

Mean change from baseline in aspartate transaminase (AST) value at week 24

Mean change from baseline in international normalized ratio (INR) value at day 1

Mean change from baseline in international normalized ratio (INR) value at day 2

Mean change from baseline in international normalized ratio (INR) value at day 3

Mean change from baseline in international normalized ratio (INR) value at day 4

Mean change from baseline in international normalized ratio (INR) value at day 5

Mean change from baseline in international normalized ratio (INR) value at day 8

Mean change from baseline in international normalized ratio (INR) value at day 11

Mean change from baseline in international normalized ratio (INR) value at day 16

Mean change from baseline in international normalized ratio (INR) value at day 24

Mean change from baseline in international normalized ratio (INR) value at day 28

Mean change from baseline in international normalized ratio (INR) value at week 8

Mean change from baseline in international normalized ratio (INR) value at week 12

Mean change from baseline in international normalized ratio (INR) value at week 16

Mean change from baseline in international normalized ratio (INR) value at week 20

Mean change from baseline in international normalized ratio (INR) value at week 24

Mean change from baseline in prothrombin time (PT) value at day 1

Mean change from baseline in prothrombin time (PT) value at day 2

Mean change from baseline in prothrombin time (PT) value at day 3

Mean change from baseline in prothrombin time (PT) value at day 4

Mean change from baseline in prothrombin time (PT) value at day 5

Mean change from baseline in prothrombin time (PT) value at day 8

Mean change from baseline in prothrombin time (PT) value at day 11

Mean change from baseline in prothrombin time (PT) value at day 16

Mean change from baseline in prothrombin time (PT) value at day 24

Mean change from baseline in prothrombin time (PT) value at day 28

Mean change from baseline in prothrombin time (PT) value at week 8

Mean change from baseline in prothrombin time (PT) value at week 12

Mean change from baseline in prothrombin time (PT) value at week 16

Mean change from baseline in prothrombin time (PT) value at week 20

Mean change from baseline in prothrombin time (PT) value at week 24

Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) \[DAIDS AE grading table\] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20

Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24

Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20

Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24

Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20

Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5

Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8