Background: Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen. Objective: To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans. Eligibility: Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen Design: Participants will be screened with: Questions Physical exam Eye exam Blood tests 2 semen samples if they have not had it tested recently Participants must live near the study site in Liberia for 6 months. Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour. Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4. After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample. Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam. When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.
With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented. There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit. This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak. Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Daily GS-5734 delivered intravenously (IV) for 5 days
Placebo delivered intravenously (IV) for 5 days.
Partnership of Clinical Research in Guinea (PREGUI) / Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah
Forécariah, Maferinyah, Guinea
JFK Hospital Partnership for Research for Vaccines and Infectious Diseases in Liberia (PREVAIL)
Monrovia, Liberia
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase
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.
Time frame: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase
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.
Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase
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.
Time frame: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase
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.
Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in ALT Value at Day 11
Mean change from baseline in alanine transaminase (ALT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) Value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) Value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) Value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 24
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for ALT Value
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)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for aPTT Value
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)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for AST Value
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)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for PT Value
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)
Time frame: Follow-up phase - Week 24
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine aminotransferase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
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