Trial Outcomes & Findings for Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer (NCT NCT02215096)

Last Updated: 2020-10-22

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, protocol-specific SAEs: All events of possible study treatment-induced liver injury with hyperbilirubinemia defined as alanine aminotransferase (ALT) \>=3 times upper limit of normal (ULN), and bilirubin \>=2 times ULN (\>35 percent \[%\] direct) (or ALT \>=3 times ULN and international normalized ratio (INR) \>1.5 if INR is measured) or termed 'Hy's Law' events (INR measurement is not required and the threshold value stated did not apply to participants receiving anticoagulants) or any new primary cancer.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

37 participants

Primary outcome timeframe

Up to Week 2

Results posted on

2020-10-22

Participant Flow

This was an open-label, dose finding study of GSK2636771 administered in combination with Enzalutamide in male participants with Metastatic Castration-Resistant Prostate Cancer (mC-RPC) conducted at 7 centers across United Kingdom and United States.

A total 37 participants were enrolled in this study and entered in the enzalutamide run-in period, of which 36 participants received GSK2636771+enzalutamide and completed the combination treatment period (TP).

Participant milestones

Participant milestones
Measure	Enzalutamide Only (run-in Period) Participants received enzalutamide monotherapy at the approved dose of 160 milligrams (mg) once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Escalation Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Run-In Period (Up to Week 2) STARTED	37	0	0	0	0
Run-In Period (Up to Week 2) COMPLETED	36	0	0	0	0
Run-In Period (Up to Week 2) NOT COMPLETED	1	0	0	0	0
Combination TP (Up to Maximum 654 Days) STARTED	0	11	11	12	2
Combination TP (Up to Maximum 654 Days) COMPLETED	0	9	10	10	1
Combination TP (Up to Maximum 654 Days) NOT COMPLETED	0	2	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Enzalutamide Only (run-in Period) Participants received enzalutamide monotherapy at the approved dose of 160 milligrams (mg) once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Escalation Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Run-In Period (Up to Week 2) Adverse Event	1	0	0	0	0
Combination TP (Up to Maximum 654 Days) Physician Decision	0	0	0	0	1
Combination TP (Up to Maximum 654 Days) Lost to Follow-up	0	0	0	1	0
Combination TP (Up to Maximum 654 Days) Withdrawal by Subject	0	2	1	1	0

Baseline Characteristics

Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=37 Participants Participant received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. In combination treatment period, participants received GSK2636771 200 mg or 300 mg or 400 mg once daily orally in combination with enzalutamide 160 mg once daily orally in dose escalation/ expansion cohorts.
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18-64 years	9 Participants n=5 Participants
Age, Customized 65-74 years	20 Participants n=5 Participants
Age, Customized >=75 years	8 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	34 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 2

Population: All Treated Safety Population consisted of all participants who received at least one dose of Enzalutamide.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=37 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) During run-in Period Non-SAEs	11 Participants	—	—	—
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) During run-in Period SAEs	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to maximum 675 days

Population: All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide. Only those participants with data available at the indicated time points were analyzed.

An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, protocol-specific SAEs: All events of possible study treatment-induced liver injury with hyperbilirubinemia defined as ALT \>=3 times ULN, and bilirubin \>=2 times ULN (\>35% direct) (or ALT \>=3 times ULN and INR \>1.5 if INR is measured) or termed 'Hy's Law' events (INR measurement is not required and the threshold value stated did not apply to participants receiving anticoagulants) or any new primary cancer.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Non-SAEs and SAEs During Combination Treatment Period Non-SAEs	11 Participants	11 Participants	12 Participants	2 Participants
Number of Participants With Non-SAEs and SAEs During Combination Treatment Period SAEs	2 Participants	2 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed.

An event was considered as DLT if the event was attributed (definitely, probably or possibly) to study treatment, occured within the first 28 days of combination treatment (DLT reporting period), and met one of the following criteria: Febrile neutropenia of any grade or duration as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 4 neutropenia lasting \>5 days, Grade 3 or greater non-hematologic toxicity that cannot be controlled with routine supportive measures, Grade 4 thrombocytopenia, ALT \>3 times ULN with bilirubin \>2 times ULN or ALT \>=3 times ULN and \>=1.5 times Baseline ALT value, if enrolled with liver metastases/tumor infiltration at Baseline), together with bilirubin \>=2 times ULN.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participant With Dose-limiting Toxicities (DLT) During Combination Treatment Period	1 Participants	0 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Weeks 2,3,4,5,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84 and 88

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, total neutrophils, platelet count and white blood cells (WBCs) count. Baseline value is the latest GSK2636771 pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100 multiplied by (post-Baseline visit value minus Baseline divided by Baseline).

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 52, n=1,1,1,0	-5.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 56, n=1,1,1,0	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	6.190 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-22.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 60, n=1,1,1,0	-5.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.420 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-22.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 64, n=1,1,1,0	-2.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.540 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-27.870 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 68, n=1,0,1,0	-2.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-15.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 72, n=0,0,1,0	—	—	-13.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 76, n=0,0,1,0	—	—	-13.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 80, n=0,0,1,0	—	—	-6.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 84, n=0,0,1,0	—	—	2.460 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 88, n=0,0,1,0	—	—	-4.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 2, n=10,9,9,2	13.128 Percent change Standard Deviation 26.4961	10.492 Percent change Standard Deviation 24.1299	6.557 Percent change Standard Deviation 14.9900	-1.110 Percent change Standard Deviation 1.5698
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 3, n=9,9,11,2	12.964 Percent change Standard Deviation 21.6078	13.431 Percent change Standard Deviation 42.8448	-1.674 Percent change Standard Deviation 23.4467	-26.515 Percent change Standard Deviation 13.9229
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 4, n=9,9,9,2	7.117 Percent change Standard Deviation 28.8484	8.342 Percent change Standard Deviation 24.6388	-10.698 Percent change Standard Deviation 14.0883	-11.665 Percent change Standard Deviation 16.4968
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 5, n=8,7,9,1	8.680 Percent change Standard Deviation 20.3405	1.481 Percent change Standard Deviation 24.0919	-6.918 Percent change Standard Deviation 18.1022	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 8, n=7,8,8,1	2.766 Percent change Standard Deviation 29.3215	-0.436 Percent change Standard Deviation 14.5663	-0.731 Percent change Standard Deviation 14.9131	36.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 12, n=5,7,7,1	4.374 Percent change Standard Deviation 31.7985	4.237 Percent change Standard Deviation 25.5117	-5.857 Percent change Standard Deviation 18.8992	-18.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 16, n=6,5,4,1	5.980 Percent change Standard Deviation 34.3145	-3.418 Percent change Standard Deviation 17.2124	-14.440 Percent change Standard Deviation 22.8645	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 20, n=4,5,4,1	7.935 Percent change Standard Deviation 23.3030	4.286 Percent change Standard Deviation 38.4387	-22.278 Percent change Standard Deviation 28.4912	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 24, n=4,3,3,1	10.143 Percent change Standard Deviation 32.9329	6.063 Percent change Standard Deviation 42.7487	-10.130 Percent change Standard Deviation 24.8888	27.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 28, n=4,2,3,1	7.328 Percent change Standard Deviation 15.4134	-37.780 Percent change Standard Deviation 25.1447	-7.750 Percent change Standard Deviation 22.4674	36.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 32, n=3,2,3,1	-1.597 Percent change Standard Deviation 30.4679	-8.485 Percent change Standard Deviation 16.2847	-12.510 Percent change Standard Deviation 27.7148	27.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 36, n=3,1,3,1	18.913 Percent change Standard Deviation 32.5921	-24.240 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.037 Percent change Standard Deviation 17.6391	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 40, n=1,1,2,1	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-30.300 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-27.855 Percent change Standard Deviation 11.1086	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 44, n=1,1,2,0	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-16.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.715 Percent change Standard Deviation 8.0822	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 48, n=1,0,1,0	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-21.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 52, n=1,0,1,0	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-21.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 56, n=1,0,1,0	-16.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 60, n=1,0,1,0	83.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 64, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 68, n=0,0,1,0	—	—	-35.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 72, n=0,0,1,0	—	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 76, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 80, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 84, n=0,0,1,0	—	—	-21.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Lymphocytes, Week 88, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 2, n= 11,11,12,2	0.360 Percent change Standard Deviation 1.0203	-0.477 Percent change Standard Deviation 0.5538	85.741 Percent change Standard Deviation 294.1068	1.020 Percent change Standard Deviation 0.9334
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 3, n=10,11,12,2	-0.341 Percent change Standard Deviation 1.7584	-1.000 Percent change Standard Deviation 1.2030	15.582 Percent change Standard Deviation 56.4264	-0.310 Percent change Standard Deviation 1.4566
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 4, n=10,11,11,2	0.042 Percent change Standard Deviation 1.3267	-0.942 Percent change Standard Deviation 1.2281	-0.277 Percent change Standard Deviation 2.0468	-0.735 Percent change Standard Deviation 1.5203
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 5, n=10,11,10,1	-0.171 Percent change Standard Deviation 1.5524	-1.856 Percent change Standard Deviation 1.4255	0.395 Percent change Standard Deviation 1.8147	-0.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 8, n=9,10,10,1	-1.582 Percent change Standard Deviation 2.0961	18.355 Percent change Standard Deviation 64.3175	-1.095 Percent change Standard Deviation 2.1396	-0.340 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 12, n=7,10,7,1	-1.779 Percent change Standard Deviation 0.8758	-2.970 Percent change Standard Deviation 2.2530	-3.199 Percent change Standard Deviation 3.6432	-2.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 16, n=8,8,4,1	-2.315 Percent change Standard Deviation 2.6806	-2.759 Percent change Standard Deviation 2.4800	-6.200 Percent change Standard Deviation 3.1007	-1.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 20, n=5,6,4,1	-1.384 Percent change Standard Deviation 3.1912	-3.355 Percent change Standard Deviation 3.6335	-1.515 Percent change Standard Deviation 3.7408	-2.010 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 24, n=5,5,3,1	-0.228 Percent change Standard Deviation 4.4495	-4.376 Percent change Standard Deviation 4.3285	-6.213 Percent change Standard Deviation 2.3011	-4.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 28, n=5,3,3,1	-0.074 Percent change Standard Deviation 4.0385	-2.653 Percent change Standard Deviation 6.3945	-7.543 Percent change Standard Deviation 4.5062	-2.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 32, n=4,3,3,1	1.873 Percent change Standard Deviation 4.2547	-2.137 Percent change Standard Deviation 4.9163	-7.767 Percent change Standard Deviation 5.6425	-3.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 36, n=3,1,3,1	2.693 Percent change Standard Deviation 2.3328	-6.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-5.237 Percent change Standard Deviation 1.9581	-8.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 40, n=1,2,2,1	3.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.255 Percent change Standard Deviation 2.4819	-7.705 Percent change Standard Deviation 3.3870	-9.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 44, n=1,2,2,0	4.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.710 Percent change Standard Deviation 0.0566	-4.425 Percent change Standard Deviation 1.8314	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 48, n=1,1,1,0	2.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-5.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 52, n=1,1,1,0	2.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 56, n=1,1,1,0	-0.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 60, n=1,1,1,0	1.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 64, n=1,1,1,0	0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.630 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 68, n=1,0,1,0	0.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-5.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 72, n=0,0,1,0	—	—	-4.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 76, n=0,0,1,0	—	—	-2.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 80, n=0,0,1,0	—	—	0.340 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 84, n=0,0,1,0	—	—	-1.010 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCH, Week 88, n=0,0,1,0	—	—	1.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 2, n= 11,11,12,2	-0.425 Percent change Standard Deviation 1.5619	-0.915 Percent change Standard Deviation 1.9177	0.101 Percent change Standard Deviation 2.0574	-2.500 Percent change Standard Deviation 1.9516
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 3, n=10,11,12,2	-0.735 Percent change Standard Deviation 1.7112	-1.025 Percent change Standard Deviation 2.1801	0.158 Percent change Standard Deviation 1.9350	-2.940 Percent change Standard Deviation 4.1578
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 4, n=10,11,11,2	-0.376 Percent change Standard Deviation 1.5149	-0.868 Percent change Standard Deviation 1.6593	-0.749 Percent change Standard Deviation 1.7087	-2.100 Percent change Standard Deviation 4.5538
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 5, n=10,11,10,1	-0.633 Percent change Standard Deviation 1.8430	-0.936 Percent change Standard Deviation 1.6268	-0.584 Percent change Standard Deviation 1.4207	1.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 8, n=9,10,10,1	-0.890 Percent change Standard Deviation 1.7420	-1.471 Percent change Standard Deviation 2.3336	-1.028 Percent change Standard Deviation 1.2245	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 12, n=7,10,7,1	-1.806 Percent change Standard Deviation 1.5447	-2.108 Percent change Standard Deviation 2.4766	-2.961 Percent change Standard Deviation 2.6274	-2.250 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 16, n=8,8,4,1	-1.353 Percent change Standard Deviation 1.5169	-2.014 Percent change Standard Deviation 1.5731	-3.160 Percent change Standard Deviation 1.6961	-2.250 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 20, n=5,6,4,1	-2.284 Percent change Standard Deviation 1.5380	-2.773 Percent change Standard Deviation 2.6459	-2.548 Percent change Standard Deviation 1.4104	-3.370 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 24, n=5,5,3,1	-2.180 Percent change Standard Deviation 2.5123	-2.976 Percent change Standard Deviation 3.1047	-3.273 Percent change Standard Deviation 2.1356	-4.490 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 28, n=5,3,3,1	-0.796 Percent change Standard Deviation 1.9042	-1.810 Percent change Standard Deviation 1.9641	-3.593 Percent change Standard Deviation 2.6835	-3.370 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 32, n=4,3,3,1	-0.243 Percent change Standard Deviation 1.0303	-0.250 Percent change Standard Deviation 1.0672	-3.913 Percent change Standard Deviation 1.5369	-1.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 36, n=3,1,3,1	-0.180 Percent change Standard Deviation 1.3888	0.770 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.397 Percent change Standard Deviation 1.6820	-4.490 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 40, n=1,2,2,1	-0.510 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.820 Percent change Standard Deviation 1.1597	-4.245 Percent change Standard Deviation 1.6051	-6.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 44, n=1,2,2,0	-0.310 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.075 Percent change Standard Deviation 4.2073	-0.895 Percent change Standard Deviation 3.3022	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 48, n=1,1,1,0	0.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.190 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 52, n=1,1,1,0	-1.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 56, n=1,1,1,0	-2.990 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 60, n=1,1,1,0	-0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 64, n=1,1,1,0	-1.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 68, n=1,0,1,0	-1.540 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 72, n=0,0,1,0	—	—	-3.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 76, n=0,0,1,0	—	—	0.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 80, n=0,0,1,0	—	—	1.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 84, n=0,0,1,0	—	—	-1.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count MCV, Week 88, n=0,0,1,0	—	—	1.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 2, n=10,9,9,2	5.541 Percent change Standard Deviation 34.2863	22.173 Percent change Standard Deviation 60.1911	-10.849 Percent change Standard Deviation 24.6931	-28.025 Percent change Standard Deviation 16.9352
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 3, n=9,9,11,2	-0.646 Percent change Standard Deviation 30.4427	-0.434 Percent change Standard Deviation 19.0109	-12.739 Percent change Standard Deviation 34.2922	-28.025 Percent change Standard Deviation 16.9352
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 4, n=9,9,9,2	1.097 Percent change Standard Deviation 33.5523	13.623 Percent change Standard Deviation 49.8243	-10.942 Percent change Standard Deviation 28.2516	-23.580 Percent change Standard Deviation 5.0629
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 5, n=8,8,9,1	-5.118 Percent change Standard Deviation 33.7156	5.200 Percent change Standard Deviation 56.5226	2.906 Percent change Standard Deviation 43.9084	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 8, n=7,8,9,1	7.991 Percent change Standard Deviation 26.3341	12.321 Percent change Standard Deviation 53.9449	-8.621 Percent change Standard Deviation 36.1243	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 12, n=5,7,7,1	1.710 Percent change Standard Deviation 23.3573	17.299 Percent change Standard Deviation 46.0764	-0.061 Percent change Standard Deviation 34.6523	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 16, n=6,5,4,1	11.403 Percent change Standard Deviation 40.0796	12.852 Percent change Standard Deviation 51.7225	0.638 Percent change Standard Deviation 19.3854	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 20, n=4,5,4,1	1.918 Percent change Standard Deviation 37.7552	-2.744 Percent change Standard Deviation 20.6555	-23.258 Percent change Standard Deviation 8.0211	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 24, n=4,3,3,1	10.033 Percent change Standard Deviation 44.7607	30.770 Percent change Standard Deviation 53.2952	-20.633 Percent change Standard Deviation 18.0268	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 28, n=4,2,3,1	13.760 Percent change Standard Deviation 32.3438	0.000 Percent change Standard Deviation 0.0000	-9.523 Percent change Standard Deviation 16.4949	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 32, n=3,2,3,1	6.360 Percent change Standard Deviation 48.8989	43.845 Percent change Standard Deviation 90.2905	-25.397 Percent change Standard Deviation 22.5044	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 36, n=3,1,3,1	13.890 Percent change Standard Deviation 34.6958	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-14.287 Percent change Standard Deviation 24.7452	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 40, n=1,1,2,1	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	134.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-23.810 Percent change Standard Deviation 13.4633	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 44, n=1,1,2,0	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	46.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-14.285 Percent change Standard Deviation 20.2020	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 48, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 52, n=1,0,1,0	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 56, n=1,0,1,0	25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 60, n=1,0,1,0	25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 64, n=0,0,1,0	—	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 68, n=0,0,1,0	—	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 72, n=0,0,1,0	—	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 76, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 80, n=0,0,1,0	—	—	-28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 84, n=0,0,1,0	—	—	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Monocytes, Week 88, n=0,0,1,0	—	—	-42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 2, n=11,11,12,2	8.585 Percent change Standard Deviation 15.9118	14.016 Percent change Standard Deviation 19.2876	6.250 Percent change Standard Deviation 13.3852	16.390 Percent change Standard Deviation 18.2434
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 3, n=10,11,12,2	-0.057 Percent change Standard Deviation 12.3510	5.440 Percent change Standard Deviation 11.6551	-1.445 Percent change Standard Deviation 10.3439	8.325 Percent change Standard Deviation 15.3654
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 4, n=10,11,11,2	-0.921 Percent change Standard Deviation 7.2065	-4.057 Percent change Standard Deviation 9.0344	-8.287 Percent change Standard Deviation 8.2288	11.095 Percent change Standard Deviation 7.1630
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 5, n=10,11,10,1	-4.600 Percent change Standard Deviation 8.7256	0.846 Percent change Standard Deviation 24.9856	-3.811 Percent change Standard Deviation 11.4610	18.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 8, n=9,10,10,1	2.416 Percent change Standard Deviation 12.6516	2.883 Percent change Standard Deviation 9.9460	2.206 Percent change Standard Deviation 11.3950	18.690 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 12, n=7, 9,7,1	6.046 Percent change Standard Deviation 15.8538	-3.291 Percent change Standard Deviation 9.0120	-1.393 Percent change Standard Deviation 12.3185	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 16, n=8,8,4,1	7.735 Percent change Standard Deviation 21.7273	-7.453 Percent change Standard Deviation 10.0630	2.405 Percent change Standard Deviation 29.4379	14.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 20, n=5,6,4,1	-3.764 Percent change Standard Deviation 11.6336	-5.373 Percent change Standard Deviation 11.3944	2.958 Percent change Standard Deviation 22.8724	14.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 24, n=5,5,3,1	0.846 Percent change Standard Deviation 18.2657	5.036 Percent change Standard Deviation 21.6048	-0.247 Percent change Standard Deviation 28.6042	23.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 28, n=5,3,3,1	-1.656 Percent change Standard Deviation 13.0916	-5.473 Percent change Standard Deviation 16.0800	-7.450 Percent change Standard Deviation 17.5451	17.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 32, n=4,3,3,1	-20.275 Percent change Standard Deviation 52.6390	-8.827 Percent change Standard Deviation 11.3729	0.790 Percent change Standard Deviation 28.4249	39.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 36, n=3,1,3,1	-2.597 Percent change Standard Deviation 19.7730	-8.820 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.967 Percent change Standard Deviation 18.8553	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 40, n=1,2,2,1	9.630 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.785 Percent change Standard Deviation 4.2356	-3.070 Percent change Standard Deviation 23.6315	57.580 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 44, n=1,2,2,0	0.460 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.160 Percent change Standard Deviation 36.1756	-9.450 Percent change Standard Deviation 9.8571	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 48, n=1,1,1,0	-5.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 52, n=1,1,1,0	-2.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 56, n=1,1,1,0	0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	7.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 60, n=1,1,1,0	16.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 64, n=1,1,1,0	-7.340 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.310 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 68, n=1,0,1,0	-0.460 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-11.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 72, n=0,0,1,0	—	—	-2.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 76, n=0,0,1,0	—	—	-26.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 80, n=0,0,1,0	—	—	-16.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 84, n=0,0,1,0	—	—	-16.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Platelet count, Week 88, n=0,0,1,0	—	—	-31.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 2, n= 10,9,9,2	6.689 Percent change Standard Deviation 45.0555	-6.798 Percent change Standard Deviation 37.2810	-3.907 Percent change Standard Deviation 19.8441	0.380 Percent change Standard Deviation 0.5374
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 3, n=9,9,11,2	-1.933 Percent change Standard Deviation 38.2961	-9.604 Percent change Standard Deviation 34.8399	-1.496 Percent change Standard Deviation 28.6849	13.885 Percent change Standard Deviation 25.0245
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 4, n=9,9,9,2	-0.562 Percent change Standard Deviation 48.2259	10.019 Percent change Standard Deviation 70.2338	-17.251 Percent change Standard Deviation 23.9291	-14.600 Percent change Standard Deviation 5.7558
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 5, n=8,8,9,1	-14.485 Percent change Standard Deviation 23.6250	-10.721 Percent change Standard Deviation 27.2234	-3.097 Percent change Standard Deviation 38.5928	36.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 8, n=7,8,9,1	-6.409 Percent change Standard Deviation 22.6409	-8.959 Percent change Standard Deviation 32.9931	-6.433 Percent change Standard Deviation 31.7619	47.370 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 12, n=5,7,7,1	-7.292 Percent change Standard Deviation 29.7757	-4.930 Percent change Standard Deviation 24.9495	-0.051 Percent change Standard Deviation 28.1875	36.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 16, n=6,5,4,1	-11.992 Percent change Standard Deviation 26.9160	-17.300 Percent change Standard Deviation 32.1449	-11.233 Percent change Standard Deviation 29.4360	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 20, n=4,5,4,1	-8.668 Percent change Standard Deviation 40.6758	-22.398 Percent change Standard Deviation 33.4115	-37.638 Percent change Standard Deviation 14.2156	31.580 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 24, n=4,3,3,1	-9.695 Percent change Standard Deviation 39.8258	537.517 Percent change Standard Deviation 875.0638	-25.860 Percent change Standard Deviation 19.3876	31.580 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 28, n=4,1,3,1	-4.173 Percent change Standard Deviation 38.7614	-23.910 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.737 Percent change Standard Deviation 30.5955	-5.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 32, n=3,2,3,1	-17.917 Percent change Standard Deviation 30.8176	43.785 Percent change Standard Deviation 117.2595	-27.140 Percent change Standard Deviation 12.5575	68.420 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 36, n=3,1,3,1	-19.807 Percent change Standard Deviation 28.6365	-13.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-22.173 Percent change Standard Deviation 19.2353	47.370 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 40, n=1,1,2,1	23.810 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	57.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.750 Percent change Standard Deviation 26.5165	-5.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 44, n=1,1,2,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.810 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.130 Percent change Standard Deviation 13.9583	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 48, n=1,0,1,0	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-23.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 52, n=1,0,1,0	61.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 56, n=1,0,1,0	4.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-21.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 60, n=1,0,1,0	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-21.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 64, n=0,0,1,0	—	—	-13.160 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 68, n=0,0,1,0	—	—	-15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 72, n=0,0,1,0	—	—	-21.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 76, n=0,0,1,0	—	—	-39.470 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 80, n=0,0,1,0	—	—	-15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 84, n=0,0,1,0	—	—	-21.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Total Neutrophils, Week 88, n=0,0,1,0	—	—	-28.950 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 2, n=11,11,12,2	6.813 Percent change Standard Deviation 29.4392	-2.077 Percent change Standard Deviation 26.5166	0.445 Percent change Standard Deviation 15.7801	-2.220 Percent change Standard Deviation 0.7920
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 3, n=10,11,12,2	1.486 Percent change Standard Deviation 24.4918	-2.625 Percent change Standard Deviation 26.9770	-3.928 Percent change Standard Deviation 20.8967	-1.715 Percent change Standard Deviation 6.3569
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 4, n=10,11,11,2	-0.001 Percent change Standard Deviation 28.4127	5.575 Percent change Standard Deviation 51.6285	-12.681 Percent change Standard Deviation 18.5282	-12.505 Percent change Standard Deviation 9.8217
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 5, n=10,11,10,1	-4.419 Percent change Standard Deviation 20.0450	-10.823 Percent change Standard Deviation 16.8580	-3.190 Percent change Standard Deviation 31.2346	19.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 8, n=9,10,10,1	-3.917 Percent change Standard Deviation 18.3295	-8.811 Percent change Standard Deviation 23.2822	-2.931 Percent change Standard Deviation 23.8804	30.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 12, n=7,10,7,1	-1.723 Percent change Standard Deviation 19.0232	-10.782 Percent change Standard Deviation 18.8356	2.471 Percent change Standard Deviation 25.2046	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 16, n=8,8,4,1	-4.974 Percent change Standard Deviation 23.1270	-16.450 Percent change Standard Deviation 20.2532	-11.380 Percent change Standard Deviation 20.6158	-2.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 20, n=5,6,4,1	-3.674 Percent change Standard Deviation 25.9508	-15.540 Percent change Standard Deviation 21.0813	-30.808 Percent change Standard Deviation 10.3805	19.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 24, n=5,5,3,1	-0.176 Percent change Standard Deviation 33.0932	2.760 Percent change Standard Deviation 47.1809	-23.037 Percent change Standard Deviation 13.3905	27.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 28, n=5,3,3,1	3.036 Percent change Standard Deviation 22.6756	-10.843 Percent change Standard Deviation 8.9673	-15.997 Percent change Standard Deviation 15.6148	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 32, n=4,3,3,1	-9.978 Percent change Standard Deviation 22.7259	14.077 Percent change Standard Deviation 73.8998	-24.583 Percent change Standard Deviation 11.4453	47.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 36, n=3,1,3,1	-6.547 Percent change Standard Deviation 29.9390	-8.810 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-17.613 Percent change Standard Deviation 6.2673	27.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 40, n=1,2,2,1	23.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	21.725 Percent change Standard Deviation 36.8756	-22.375 Percent change Standard Deviation 12.3532	-5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 44, n=1,2,2,0	-7.690 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.525 Percent change Standard Deviation 6.6822	-17.225 Percent change Standard Deviation 0.7849	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 48, n=1,1,1,0	-5.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 52, n=1,1,1,0	35.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 56, n=1,1,1,0	-7.690 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 60, n=1,1,1,0	43.590 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 64, n=1,1,1,0	15.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.250 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-24.240 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 68, n=1,0,1,0	-2.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-25.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 72, n=0,0,1,0	—	—	-27.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 76, n=0,0,1,0	—	—	-42.420 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 80, n=0,0,1,0	—	—	-27.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 84, n=0,0,1,0	—	—	-24.240 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count WBC count, Week 88, n=0,0,1,0	—	—	-36.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 44, n=1,2,2,0	-4.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.650 Percent change Standard Deviation 9.8146	-8.725 Percent change Standard Deviation 8.2944	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 44, n=1,2,2,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.815 Percent change Standard Deviation 13.9936	-11.970 Percent change Standard Deviation 12.0491	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 48, n=1,1,1,0	-2.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	5.310 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-17.210 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 2, n=5,4,5,1	20.000 Percent change Standard Deviation 103.6822	0.000 Percent change Standard Deviation 0.0000	30.000 Percent change Standard Deviation 48.0885	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 3, n=5,5,6,1	0.000 Percent change Standard Deviation 70.7107	27.500 Percent change Standard Deviation 43.6606	-16.270 Percent change Standard Deviation 38.4859	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 4, n=5,4,5,1	-16.666 Percent change Standard Deviation 79.9314	25.000 Percent change Standard Deviation 50.0000	26.666 Percent change Standard Deviation 43.4612	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 5, n=4,4,5,0	-37.500 Percent change Standard Deviation 94.6485	25.000 Percent change Standard Deviation 50.0000	27.380 Percent change Standard Deviation 46.9143	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 8, n=4,4,4,0	-12.500 Percent change Standard Deviation 25.0000	25.000 Percent change Standard Deviation 50.0000	139.583 Percent change Standard Deviation 188.2399	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 12, n=3,4,3,0	0.000 Percent change Standard Deviation 100.0000	25.000 Percent change Standard Deviation 50.0000	51.190 Percent change Standard Deviation 42.3084	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 16, n=3,4,1,0	-33.333 Percent change Standard Deviation 57.7350	16.668 Percent change Standard Deviation 33.3350	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 20, n=2,3,1,0	-50.000 Percent change Standard Deviation 70.7107	0.000 Percent change Standard Deviation 0.0000	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 24, n=2,1,0,0	-50.000 Percent change Standard Deviation 70.7107	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 28, n=1,0,0,0	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 32, n=2,1,0,0	0.000 Percent change Standard Deviation 141.4214	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 36, n=2,1,0,0	-50.000 Percent change Standard Deviation 70.7107	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 40, n=0,1,0,0	—	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Basophils, Week 44, n=0,1,0,0	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 2, n=9,8,8,2	-26.321 Percent change Standard Deviation 47.4470	-8.754 Percent change Standard Deviation 30.6984	-19.135 Percent change Standard Deviation 47.3780	-2.175 Percent change Standard Deviation 3.0759
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 3, n=8,8,9,2	13.085 Percent change Standard Deviation 40.8232	13.994 Percent change Standard Deviation 65.2691	4.704 Percent change Standard Deviation 68.1450	54.350 Percent change Standard Deviation 64.5588
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 4, n=8,8,8,2	11.136 Percent change Standard Deviation 36.6046	-3.626 Percent change Standard Deviation 75.4907	13.333 Percent change Standard Deviation 57.7624	-2.175 Percent change Standard Deviation 3.0759
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 5, n= 7,7,8,1	54.970 Percent change Standard Deviation 110.7083	-23.809 Percent change Standard Deviation 43.1487	9.708 Percent change Standard Deviation 42.6803	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 8, n=6,7,8,1	16.857 Percent change Standard Deviation 53.6217	5.953 Percent change Standard Deviation 32.8832	90.104 Percent change Standard Deviation 102.6830	-100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 12, n=4,6,6,1	31.250 Percent change Standard Deviation 47.3242	1.390 Percent change Standard Deviation 41.6394	72.578 Percent change Standard Deviation 129.4696	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 16, n=5,5,3,1	2.120 Percent change Standard Deviation 15.8040	-17.626 Percent change Standard Deviation 34.2120	62.500 Percent change Standard Deviation 119.2424	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 20, n=3,5,3,1	9.090 Percent change Standard Deviation 15.7443	15.000 Percent change Standard Deviation 81.7340	66.667 Percent change Standard Deviation 115.4701	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 24, n=3,3,2,1	18.183 Percent change Standard Deviation 31.4945	-50.000 Percent change Standard Deviation 66.1438	50.000 Percent change Standard Deviation 70.7107	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 28, n=3,2,2,1	44.950 Percent change Standard Deviation 63.9644	-87.500 Percent change Standard Deviation 17.6777	0.000 Percent change Standard Deviation 141.4214	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 32, n=4,2,2,1	589.773 Percent change Standard Deviation 1140.3590	-25.000 Percent change Standard Deviation 106.0660	0.000 Percent change Standard Deviation 141.4214	-100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 36, n=3,1,2,1	13.890 Percent change Standard Deviation 24.0582	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation 141.4214	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 40, n=1,1,1,1	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	125.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 44, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 48, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	200.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 52, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	300.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 56, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	200.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 60, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	200.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 64, n=0,0,1,0	—	—	200.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 72, n=0,0,1,0	—	—	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 76, n=0,0,1,0	—	—	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 80, n=0,0,1,0	—	—	200.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 84, n=0,0,1,0	—	—	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Eosinophils, Week 88, n=0,0,1,0	—	—	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 2, n=10,11,12,2	0.587 Percent change Standard Deviation 6.3505	1.183 Percent change Standard Deviation 4.5122	-0.387 Percent change Standard Deviation 4.2431	-1.480 Percent change Standard Deviation 3.9739
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 3, n=9,11,12,2	-1.006 Percent change Standard Deviation 3.4842	1.595 Percent change Standard Deviation 4.8860	0.138 Percent change Standard Deviation 4.7403	-4.355 Percent change Standard Deviation 16.3412
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 4, n=9,11,11,2	0.593 Percent change Standard Deviation 3.8149	0.292 Percent change Standard Deviation 4.1522	-1.677 Percent change Standard Deviation 5.4977	-7.650 Percent change Standard Deviation 13.4633
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 5, n=10,11,10,1	-1.018 Percent change Standard Deviation 4.1817	-1.864 Percent change Standard Deviation 7.0759	-0.131 Percent change Standard Deviation 3.8130	4.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 8, n=9,10,10,1	0.604 Percent change Standard Deviation 5.0812	-0.771 Percent change Standard Deviation 6.0100	-0.511 Percent change Standard Deviation 5.3238	8.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 12, n=6,10,7,1	1.648 Percent change Standard Deviation 5.3385	-2.580 Percent change Standard Deviation 5.8249	-18.046 Percent change Standard Deviation 31.9934	1.600 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 16, n=7,8,4,1	-1.459 Percent change Standard Deviation 5.9511	-3.929 Percent change Standard Deviation 6.5991	-9.515 Percent change Standard Deviation 9.0652	1.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 20, n=5,6,4,1	2.638 Percent change Standard Deviation 6.8653	-2.392 Percent change Standard Deviation 7.0021	-7.138 Percent change Standard Deviation 7.7051	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 24, n=5,5,3,1	0.662 Percent change Standard Deviation 8.0118	-2.974 Percent change Standard Deviation 8.6014	-7.580 Percent change Standard Deviation 7.0381	2.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 28, n=5,3,3,1	2.004 Percent change Standard Deviation 5.2368	-9.047 Percent change Standard Deviation 17.3470	-7.793 Percent change Standard Deviation 10.5539	3.470 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 32, n=4,3,3,1	0.365 Percent change Standard Deviation 9.8402	-1.917 Percent change Standard Deviation 4.8321	-7.827 Percent change Standard Deviation 12.0475	-2.930 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 36, n=3,1,3,1	1.320 Percent change Standard Deviation 8.9495	-16.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.420 Percent change Standard Deviation 4.1589	-8.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 40, n=1,2,2,1	-4.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.755 Percent change Standard Deviation 11.3632	-21.690 Percent change Standard Deviation 14.8068	-10.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 48, n=1,1,1,0	-4.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-13.510 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 52, n=1,1,1,0	-8.370 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.540 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 56, n=1,1,1,0	-12.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 60, n=1,1,1,0	-7.420 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 64, n=1,1,1,0	-5.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.950 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-22.970 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 68, n=1,0,1,0	-4.310 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-10.810 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 72, n=0,0,1,0	—	—	-12.160 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 76, n=0,0,1,0	—	—	-11.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 80, n=0,0,1,0	—	—	-5.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 84, n=0,0,1,0	—	—	1.890 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hematocrit, Week 88, n=0,0,1,0	—	—	-4.320 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 2, n=11,11,12,2	1.513 Percent change Standard Deviation 6.4384	1.831 Percent change Standard Deviation 4.2681	0.216 Percent change Standard Deviation 4.9536	2.800 Percent change Standard Deviation 3.9598
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 3, n=10,11,12,2	-1.144 Percent change Standard Deviation 3.3900	1.874 Percent change Standard Deviation 5.1494	-1.001 Percent change Standard Deviation 4.4522	-1.760 Percent change Standard Deviation 11.5400
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 4, n=10,11,11,2	0.821 Percent change Standard Deviation 3.7955	0.564 Percent change Standard Deviation 3.8663	-1.301 Percent change Standard Deviation 5.4112	-6.225 Percent change Standard Deviation 11.0662
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 5, n=10,11,10,1	-0.755 Percent change Standard Deviation 4.7629	-2.550 Percent change Standard Deviation 6.7380	0.889 Percent change Standard Deviation 4.4094	2.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 8, n=9,10,10,1	-0.313 Percent change Standard Deviation 4.4329	-1.203 Percent change Standard Deviation 5.3379	-0.633 Percent change Standard Deviation 5.7100	8.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 12, n=7,10,7,1	-0.121 Percent change Standard Deviation 6.0781	-3.316 Percent change Standard Deviation 5.0843	-4.847 Percent change Standard Deviation 7.8349	0.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 16, n=8,8,4,1	-4.005 Percent change Standard Deviation 8.7693	-4.451 Percent change Standard Deviation 6.7484	-12.315 Percent change Standard Deviation 9.9652	2.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 20, n=5,6,4,1	2.906 Percent change Standard Deviation 8.7982	-2.668 Percent change Standard Deviation 7.5665	-9.055 Percent change Standard Deviation 9.7215	1.600 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 24, n=5,5,3,1	2.148 Percent change Standard Deviation 8.8710	-4.124 Percent change Standard Deviation 8.6379	-10.137 Percent change Standard Deviation 7.6478	2.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 28, n=5,3,3,1	2.410 Percent change Standard Deviation 6.9580	-8.843 Percent change Standard Deviation 21.8918	-11.723 Percent change Standard Deviation 11.7348	4.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 32, n=4,3,3,1	2.838 Percent change Standard Deviation 11.6934	-3.430 Percent change Standard Deviation 6.2333	-11.350 Percent change Standard Deviation 15.5425	-4.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 36, n=3,1,3,1	4.303 Percent change Standard Deviation 8.7527	-22.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-5.893 Percent change Standard Deviation 4.9326	-12.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, MCH, MCV, Monocytes, Total Neutrophils, Platelet Count, WBC Count Hemoglobin, Week 40, n=1,2,2,1	-1.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.165 Percent change Standard Deviation 12.6360	-24.305 Percent change Standard Deviation 17.7979	-11.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.

PRIMARY outcome

Timeframe: Baseline (Day 1), Week 4

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the hematology parameters: INR, PT and PTT. Baseline value is the latest GSK2636771 pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100 multiplied by (post-Baseline visit value minus Baseline divided by Baseline).

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=10 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=9 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=11 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: International Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) INR, n=9,9,11,1	-9.266 Percent change Standard Deviation 31.1026	1.230 Percent change Standard Deviation 3.7353	0.287 Percent change Standard Deviation 0.6848	11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: International Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) PT, n=9,9,11,0	114.626 Percent change Standard Deviation 344.5226	-0.677 Percent change Standard Deviation 5.5257	1.328 Percent change Standard Deviation 1.9928	—
Percent Change From Baseline in Hematology Parameters During Combination Treatment Period: International Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) PTT, n=10,9,11,0	252.137 Percent change Standard Deviation 799.4078	3.480 Percent change Standard Deviation 11.0842	4.596 Percent change Standard Deviation 4.3461	—

PRIMARY outcome

Timeframe: Baseline (Day 1), Weeks 1,2,3,4,5,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84 and 88

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the chemistry parameters: ALT, Albumin, Alkaline phosphatase (ALP), Aspartate amino transferase (AST), Calcium, Carbon dioxide (CO2), Chloride, Creatinine, Direct bilirubin, Glucose, Lactate dehydrogenase, Magnesium, Potassium, Sodium, Total bilirubin and Total protein. Baseline value is the latest GSK2636771 pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100 multiplied by (post-Baseline visit value minus Baseline divided by Baseline).

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 8, n=9,10,9,0	-6.336 Percent change Standard Deviation 7.2636	2.039 Percent change Standard Deviation 9.9294	2.270 Percent change Standard Deviation 6.9135	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 12, n=6,10,7,0	-4.483 Percent change Standard Deviation 11.0452	0.176 Percent change Standard Deviation 8.2049	-1.396 Percent change Standard Deviation 7.6354	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 1, n=0,0,3,1	—	—	19.283 Percent change Standard Deviation 22.1495	42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 2, n=11,11,12,2	24.745 Percent change Standard Deviation 33.0344	26.454 Percent change Standard Deviation 40.8793	37.503 Percent change Standard Deviation 19.7223	35.715 Percent change Standard Deviation 10.1046
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 3, n=10,11,12,2	23.264 Percent change Standard Deviation 31.2843	32.356 Percent change Standard Deviation 43.4898	30.123 Percent change Standard Deviation 16.5230	14.285 Percent change Standard Deviation 20.2020
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 4, n=10,11,11,2	29.468 Percent change Standard Deviation 30.6030	42.434 Percent change Standard Deviation 57.8048	58.457 Percent change Standard Deviation 62.8020	28.575 Percent change Standard Deviation 20.2020
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 5, n= 10,11,10,1	29.714 Percent change Standard Deviation 30.3371	45.801 Percent change Standard Deviation 36.5261	39.647 Percent change Standard Deviation 33.2853	28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 8, n=9,10,10,1	53.636 Percent change Standard Deviation 62.0500	57.566 Percent change Standard Deviation 61.0093	32.372 Percent change Standard Deviation 26.1619	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 12, n=7,10,7,1	31.460 Percent change Standard Deviation 37.8221	45.549 Percent change Standard Deviation 37.9079	21.621 Percent change Standard Deviation 22.5414	28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 16, n=8,8,4,1	30.841 Percent change Standard Deviation 36.3547	37.271 Percent change Standard Deviation 41.2228	25.113 Percent change Standard Deviation 50.7297	57.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 20, n=5,6,4,1	31.442 Percent change Standard Deviation 28.4784	17.172 Percent change Standard Deviation 47.1226	19.048 Percent change Standard Deviation 26.0889	42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 24, n=5,5,3,1	25.280 Percent change Standard Deviation 29.7220	23.628 Percent change Standard Deviation 56.9181	26.863 Percent change Standard Deviation 9.1878	57.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 28, n=5,4,3,1	48.140 Percent change Standard Deviation 25.3878	-15.128 Percent change Standard Deviation 35.7843	9.793 Percent change Standard Deviation 10.6010	57.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 32, n=4,3,3,1	44.170 Percent change Standard Deviation 29.4179	-31.510 Percent change Standard Deviation 5.3476	7.970 Percent change Standard Deviation 11.6457	42.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 36, n=3,1,3,1	53.580 Percent change Standard Deviation 26.3536	-6.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.180 Percent change Standard Deviation 11.3589	-14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 40, n=1,2,2,1	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-27.060 Percent change Standard Deviation 0.5515	-0.495 Percent change Standard Deviation 8.1388	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 44, n=1,2,2,0	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	6.075 Percent change Standard Deviation 66.8287	-3.125 Percent change Standard Deviation 4.4194	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 48, n=1,1,1,0	100.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-19.610 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 52, n=1,1,1,0	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-43.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 56, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-47.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-5.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 60, n=1,1,1,0	25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 64, n=1,1,1,0	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-49.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 68, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	26.320 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 72, n=0,0,1,0	—	—	42.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 76, n=0,0,1,0	—	—	-15.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 80, n=0,0,1,0	—	—	10.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 84, n=0,0,1,0	—	—	-5.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALT:Week 88, n=0,0,1,0	—	—	5.260 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 1, n=0,0,3,1	—	—	1.450 Percent change Standard Deviation 2.5115	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 2, n=11,11,12,2	1.895 Percent change Standard Deviation 7.5980	-2.445 Percent change Standard Deviation 5.0415	0.137 Percent change Standard Deviation 6.3551	-3.230 Percent change Standard Deviation 10.7197
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 3, n=10,11,12,2	0.642 Percent change Standard Deviation 7.8696	-1.401 Percent change Standard Deviation 5.7148	-2.284 Percent change Standard Deviation 11.8853	-5.670 Percent change Standard Deviation 11.0874
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 4, n=10,11,11,2	2.024 Percent change Standard Deviation 3.2354	-1.667 Percent change Standard Deviation 3.7915	-1.075 Percent change Standard Deviation 4.8150	-8.665 Percent change Standard Deviation 3.0335
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 5, n= 10,11,10,1	0.625 Percent change Standard Deviation 5.4575	-0.532 Percent change Standard Deviation 4.3994	0.597 Percent change Standard Deviation 5.0133	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 8, n=9,10,10,1	3.182 Percent change Standard Deviation 3.5152	-2.282 Percent change Standard Deviation 3.3157	1.648 Percent change Standard Deviation 6.0048	10.870 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 12, n=6,10,7,1	1.805 Percent change Standard Deviation 7.7531	-4.026 Percent change Standard Deviation 5.6375	0.547 Percent change Standard Deviation 4.3503	-2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 16, n=8,8,4,1	0.755 Percent change Standard Deviation 6.1997	-4.880 Percent change Standard Deviation 4.0347	-3.378 Percent change Standard Deviation 5.6123	2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 20, n=5,6,4,1	0.596 Percent change Standard Deviation 10.1128	-3.827 Percent change Standard Deviation 6.8293	0.130 Percent change Standard Deviation 6.2519	2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 24, n=5,5,3,1	1.070 Percent change Standard Deviation 5.9309	-4.052 Percent change Standard Deviation 4.0523	-1.130 Percent change Standard Deviation 3.9870	4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 28, n=5,4,3,1	0.668 Percent change Standard Deviation 5.4560	-8.870 Percent change Standard Deviation 8.1232	1.147 Percent change Standard Deviation 5.8101	2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 32, n=4,3,3,1	3.635 Percent change Standard Deviation 8.4967	-5.747 Percent change Standard Deviation 4.0772	-3.603 Percent change Standard Deviation 7.9065	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 36, n=3,1,3,1	2.403 Percent change Standard Deviation 4.6570	-9.300 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.180 Percent change Standard Deviation 5.0541	-2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 40, n=1,2,2,1	-9.300 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.650 Percent change Standard Deviation 9.8712	-7.730 Percent change Standard Deviation 4.7800	2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 44, n=1,2,2,0	-4.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.490 Percent change Standard Deviation 4.9356	-0.905 Percent change Standard Deviation 10.5005	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 48, n=1,1,1,0	-4.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 52, n=1,1,1,0	-6.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 56, n=1,1,1,0	-9.300 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 60, n=1,1,1,0	-9.300 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 64, n=1,1,1,0	-6.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 68, n=1,0,1,0	-6.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 72, n=0,0,1,0	—	—	-8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 76, n=0,0,1,0	—	—	-11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 80, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 84, n=0,0,1,0	—	—	-2.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Albumin:Week 88, n=0,0,1,0	—	—	-13.890 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 1, n=0,0,3,1	—	—	-4.147 Percent change Standard Deviation 6.3515	-5.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 2, n=11,10,12,2	3.165 Percent change Standard Deviation 15.9188	2.881 Percent change Standard Deviation 13.4737	2.665 Percent change Standard Deviation 19.2406	-3.660 Percent change Standard Deviation 16.4897
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 3, n=10,10,12,2	6.972 Percent change Standard Deviation 10.8810	5.072 Percent change Standard Deviation 17.3872	-0.942 Percent change Standard Deviation 15.7497	10.000 Percent change Standard Deviation 14.1421
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 4, n=10,10,11,2	3.496 Percent change Standard Deviation 11.7663	11.790 Percent change Standard Deviation 21.9785	-2.819 Percent change Standard Deviation 16.9420	21.665 Percent change Standard Deviation 16.4968
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 5, n=10,11,10,1	3.251 Percent change Standard Deviation 14.5791	11.901 Percent change Standard Deviation 20.1563	0.269 Percent change Standard Deviation 17.4773	8.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 8, n=9,10,10,1	4.360 Percent change Standard Deviation 12.8823	12.790 Percent change Standard Deviation 27.1346	-1.651 Percent change Standard Deviation 18.0020	28.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 12, n=7,10,7,1	1.306 Percent change Standard Deviation 18.5543	11.758 Percent change Standard Deviation 37.2451	-3.350 Percent change Standard Deviation 17.4644	6.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 16, n=8,8,4,1	2.364 Percent change Standard Deviation 35.6322	18.066 Percent change Standard Deviation 54.1061	-10.875 Percent change Standard Deviation 7.5274	22.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 20, n=5,6,4,1	-19.620 Percent change Standard Deviation 7.2268	25.492 Percent change Standard Deviation 87.1563	-13.655 Percent change Standard Deviation 8.0427	18.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 24, n=5,5,3,1	-20.088 Percent change Standard Deviation 8.7955	71.670 Percent change Standard Deviation 167.7482	-18.933 Percent change Standard Deviation 5.0374	16.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 28, n=5,4,3,1	-15.240 Percent change Standard Deviation 11.3616	75.765 Percent change Standard Deviation 161.7779	-16.040 Percent change Standard Deviation 11.2100	14.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 32, n=4,3,3,1	-16.640 Percent change Standard Deviation 11.5509	84.763 Percent change Standard Deviation 119.3992	-10.653 Percent change Standard Deviation 22.0605	38.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 36, n=3,1,3,1	-9.937 Percent change Standard Deviation 4.2691	173.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-9.480 Percent change Standard Deviation 18.9095	24.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 40, n=1,2,2,1	-3.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	24.230 Percent change Standard Deviation 59.4818	-20.895 Percent change Standard Deviation 0.1485	12.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 44, n=1,2,2,0	5.770 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	51.715 Percent change Standard Deviation 133.4381	-14.000 Percent change Standard Deviation 19.7990	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 48, n=1,1,1,0	1.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-29.460 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-21.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 52, n=1,1,1,0	9.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-44.190 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 56, n=1,1,1,0	1.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-41.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 60, n=1,1,1,0	-15.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-24.810 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 64, n=1,1,1,0	-19.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-37.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-11.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 68, n=1,0,1,0	-9.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-12.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 72, n=0,0,1,0	—	—	-13.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 76, n=0,0,1,0	—	—	-26.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 80, n=0,0,1,0	—	—	-14.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 84, n=0,0,1,0	—	—	-9.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein ALP:Week 88, n=0,0,1,0	—	—	-3.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 1, n=0,0,3,1	—	—	17.083 Percent change Standard Deviation 4.0182	27.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 2, n=11,11,12,1	15.050 Percent change Standard Deviation 26.7980	10.286 Percent change Standard Deviation 21.5863	18.918 Percent change Standard Deviation 29.8292	11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 3, n=10,11,12,1	8.979 Percent change Standard Deviation 17.9450	6.365 Percent change Standard Deviation 20.9402	9.471 Percent change Standard Deviation 29.6507	-5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 4, n=10,11,11,1	10.427 Percent change Standard Deviation 13.4082	24.937 Percent change Standard Deviation 41.2658	8.762 Percent change Standard Deviation 32.5615	22.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 5, n=10,11,10,0	7.934 Percent change Standard Deviation 22.4691	31.374 Percent change Standard Deviation 27.5174	13.756 Percent change Standard Deviation 38.8757	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 8, n=9,10,10,0	33.676 Percent change Standard Deviation 31.1394	25.584 Percent change Standard Deviation 65.6073	11.455 Percent change Standard Deviation 21.3067	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 12, n=7,10,7,0	16.030 Percent change Standard Deviation 15.7802	29.940 Percent change Standard Deviation 33.2473	27.560 Percent change Standard Deviation 28.1989	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 16, n=8,8,4,0	31.790 Percent change Standard Deviation 33.3934	21.604 Percent change Standard Deviation 29.1979	32.398 Percent change Standard Deviation 52.6950	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 20, n=5,6,4,0	13.548 Percent change Standard Deviation 8.4530	3.055 Percent change Standard Deviation 33.4592	23.855 Percent change Standard Deviation 14.8504	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 24, n=5,5,3,0	14.364 Percent change Standard Deviation 11.9664	9.360 Percent change Standard Deviation 38.6693	6.807 Percent change Standard Deviation 32.9686	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 28, n=5,4,3,0	23.032 Percent change Standard Deviation 18.8242	-12.230 Percent change Standard Deviation 25.1693	15.000 Percent change Standard Deviation 13.2288	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 32, n=4,3,3,0	17.590 Percent change Standard Deviation 14.7541	-39.743 Percent change Standard Deviation 7.1666	26.943 Percent change Standard Deviation 30.4636	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 36, n=3,1,3,0	23.717 Percent change Standard Deviation 4.7627	-5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	13.193 Percent change Standard Deviation 27.9755	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 40, n=1,2,2,0	35.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.060 Percent change Standard Deviation 25.3710	-2.085 Percent change Standard Deviation 14.7290	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 44, n=1,2,2,0	23.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.060 Percent change Standard Deviation 46.5842	6.250 Percent change Standard Deviation 26.5165	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 48, n=1,1,1,0	35.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-29.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 52, n=1,1,1,0	11.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 56, n=1,1,1,0	17.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-18.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 60, n=1,1,1,0	11.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-39.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 64, n=1,1,1,0	58.820 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-57.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 68, n=1,0,1,0	47.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 72, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 76, n=0,0,1,0	—	—	-31.250 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 80, n=0,0,1,0	—	—	12.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 84, n=0,0,1,0	—	—	-18.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein AST:Week 88, n=0,0,1,0	—	—	-18.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 1, n=0,0,3,1	—	—	-5.307 Percent change Standard Deviation 1.8287	-3.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 2, n=11,11,12,2	-4.765 Percent change Standard Deviation 6.1486	-3.451 Percent change Standard Deviation 4.2733	-8.617 Percent change Standard Deviation 6.2882	-5.240 Percent change Standard Deviation 9.2207
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 3, n=10,11,12,2	-4.547 Percent change Standard Deviation 7.2916	-1.819 Percent change Standard Deviation 3.4578	-4.798 Percent change Standard Deviation 3.5578	-1.830 Percent change Standard Deviation 7.3963
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 4, n=10,10,11,2	-4.768 Percent change Standard Deviation 5.4864	-2.178 Percent change Standard Deviation 5.4456	-6.373 Percent change Standard Deviation 4.8535	-6.960 Percent change Standard Deviation 13.4492
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 5, n=10,11,10,1	-5.613 Percent change Standard Deviation 4.6806	-1.622 Percent change Standard Deviation 5.5177	-4.908 Percent change Standard Deviation 4.6481	3.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 8, n=9,10,10,1	-5.359 Percent change Standard Deviation 3.8797	-2.750 Percent change Standard Deviation 3.5749	-4.512 Percent change Standard Deviation 3.8618	2.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 12, n=6,10,7,1	-3.578 Percent change Standard Deviation 5.6792	-2.962 Percent change Standard Deviation 2.8943	-6.034 Percent change Standard Deviation 5.0312	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 16, n=8,8,4,1	-4.259 Percent change Standard Deviation 4.3485	-4.580 Percent change Standard Deviation 3.6844	-6.105 Percent change Standard Deviation 3.9821	1.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 20, n=5,6,4,1	-5.090 Percent change Standard Deviation 5.8459	0.690 Percent change Standard Deviation 4.7342	-5.103 Percent change Standard Deviation 3.7503	1.280 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 24, n=5,5,3,1	-3.500 Percent change Standard Deviation 2.1050	-2.694 Percent change Standard Deviation 1.8159	-5.127 Percent change Standard Deviation 4.9099	5.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 28, n=5,4,3,1	-2.380 Percent change Standard Deviation 2.0033	-3.428 Percent change Standard Deviation 4.0359	-5.423 Percent change Standard Deviation 6.4883	5.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 32, n=4,3,3,1	-4.595 Percent change Standard Deviation 3.5314	-0.747 Percent change Standard Deviation 2.2739	-6.553 Percent change Standard Deviation 5.6435	1.280 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 36, n=3,1,3,1	-5.473 Percent change Standard Deviation 3.5181	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-5.210 Percent change Standard Deviation 5.7373	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 40, n=1,1,2,1	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.275 Percent change Standard Deviation 11.1086	2.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 44, n=1,2,2,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.075 Percent change Standard Deviation 7.6014	-1.760 Percent change Standard Deviation 9.6732	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 48, n=1,1,1,0	-8.160 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 52, n=1,1,1,0	-1.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.600 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 56, n=1,1,1,0	-7.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 60, n=1,1,1,0	-5.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-11.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 64, n=1,1,1,0	-5.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 68, n=1,0,1,0	-2.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-8.600 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 72, n=0,0,1,0	—	—	-7.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 76, n=0,0,1,0	—	—	-11.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 80, n=0,0,1,0	—	—	-10.750 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 84, n=0,0,1,0	—	—	-6.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Calcium:Week 88, n=0,0,1,0	—	—	-11.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 1, n=0,0,3,1	—	—	-4.130 Percent change Standard Deviation 7.0589	-4.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 16, n=8,8,4,0	-3.400 Percent change Standard Deviation 5.6016	-0.616 Percent change Standard Deviation 11.9261	-5.348 Percent change Standard Deviation 3.8920	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 2, n=11,11,12,2	-7.175 Percent change Standard Deviation 5.9450	-1.014 Percent change Standard Deviation 9.8790	0.698 Percent change Standard Deviation 4.2233	-8.330 Percent change Standard Deviation 17.6777
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 3, n=10,11,12,2	-5.396 Percent change Standard Deviation 8.3219	-0.359 Percent change Standard Deviation 9.4162	3.494 Percent change Standard Deviation 8.5276	4.165 Percent change Standard Deviation 11.7875
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 4, n=10,11,11,2	-4.261 Percent change Standard Deviation 6.6572	-0.885 Percent change Standard Deviation 8.7334	1.185 Percent change Standard Deviation 6.3365	6.250 Percent change Standard Deviation 2.9416
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 5, n=10,11,10,1	-6.484 Percent change Standard Deviation 6.1629	-0.911 Percent change Standard Deviation 13.3754	-1.661 Percent change Standard Deviation 7.0570	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 20, n=5,6,4,0	-1.334 Percent change Standard Deviation 2.9829	2.323 Percent change Standard Deviation 11.0928	0.200 Percent change Standard Deviation 4.9861	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 24, n=5,5,3,1	-2.548 Percent change Standard Deviation 8.4654	-0.350 Percent change Standard Deviation 10.9158	-2.617 Percent change Standard Deviation 2.2673	4.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 28, n=5,4,3,1	0.454 Percent change Standard Deviation 8.9936	1.625 Percent change Standard Deviation 9.1644	0.050 Percent change Standard Deviation 3.9252	8.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 32, n=4,3,3,1	-3.868 Percent change Standard Deviation 9.1162	-3.570 Percent change Standard Deviation 3.5700	6.513 Percent change Standard Deviation 5.9119	12.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 36, n=3,1,3,1	0.277 Percent change Standard Deviation 19.0084	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.230 Percent change Standard Deviation 5.9413	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 40, n=1,2,2,1	3.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation 5.0487	9.000 Percent change Standard Deviation 1.4142	-4.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 44, n=1,2,2,0	-6.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.570 Percent change Standard Deviation 5.0487	2.000 Percent change Standard Deviation 2.8284	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 48, n=1,1,1,0	-3.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 56, n=1,1,1,0	-1.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	9.240 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 52, n=1,1,1,0	6.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 56, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 60, n=1,1,1,0	-13.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 64, n=1,1,1,0	-6.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 68, n=1,0,1,0	-3.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	15.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 72, n=0,0,1,0	—	—	5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 76, n=0,0,1,0	—	—	5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 80, n=0,0,1,0	—	—	20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 84, n=0,0,1,0	—	—	15.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein CO2:Week 88, n=0,0,1,0	—	—	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 1, n=0,0,3,1	—	—	0.000 Percent change Standard Deviation 1.9600	4.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 2, n=11,11,12,1	1.285 Percent change Standard Deviation 2.5760	1.720 Percent change Standard Deviation 2.0330	0.278 Percent change Standard Deviation 2.1853	-1.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 3, n=10,11,12,1	1.110 Percent change Standard Deviation 3.1963	2.169 Percent change Standard Deviation 1.5618	1.042 Percent change Standard Deviation 1.6055	1.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 4, n=10,11,11,1	1.786 Percent change Standard Deviation 1.2600	1.259 Percent change Standard Deviation 1.9801	0.270 Percent change Standard Deviation 1.2350	2.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 5, n=10,11,10,0	1.038 Percent change Standard Deviation 3.8548	0.825 Percent change Standard Deviation 2.3370	-0.495 Percent change Standard Deviation 2.5736	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 8, n=9,10,10,0	1.342 Percent change Standard Deviation 1.8157	0.514 Percent change Standard Deviation 2.3134	-1.613 Percent change Standard Deviation 2.5122	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 12, n=5,10,7,0	2.218 Percent change Standard Deviation 2.8158	1.564 Percent change Standard Deviation 2.1107	-1.077 Percent change Standard Deviation 1.4931	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 16, n=8,8,4,0	1.379 Percent change Standard Deviation 2.5654	1.979 Percent change Standard Deviation 1.6634	-0.755 Percent change Standard Deviation 2.3017	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 20, n=5,6,4,0	1.818 Percent change Standard Deviation 3.2011	2.842 Percent change Standard Deviation 2.1684	0.470 Percent change Standard Deviation 1.2655	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 24, n=5,5,3,0	1.016 Percent change Standard Deviation 2.5283	0.204 Percent change Standard Deviation 2.6191	-0.590 Percent change Standard Deviation 1.9337	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 28, n=5,4,3,0	2.012 Percent change Standard Deviation 1.2468	1.515 Percent change Standard Deviation 1.3092	0.050 Percent change Standard Deviation 1.6282	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 32, n=4,3,3,0	2.230 Percent change Standard Deviation 0.4359	2.027 Percent change Standard Deviation 2.0200	-0.377 Percent change Standard Deviation 1.9704	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 36, n=3,1,3,0	1.703 Percent change Standard Deviation 1.5832	1.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.283 Percent change Standard Deviation 2.0455	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 40, n=1,2,2,0	2.970 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.560 Percent change Standard Deviation 6.4771	-0.500 Percent change Standard Deviation 0.7071	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 44, n=1,2,2,0	1.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.525 Percent change Standard Deviation 0.7283	0.460 Percent change Standard Deviation 0.6505	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 48, n=1,1,1,0	3.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 52, n=1,1,1,0	0.990 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 56, n=1,1,1,0	2.970 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.010 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 60, n=1,1,1,0	5.940 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.010 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 64, n=1,1,1,0	3.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 68, n=1,0,1,0	4.950 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 72, n=0,0,1,0	—	—	-0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 76, n=0,0,1,0	—	—	1.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 80, n=0,0,1,0	—	—	-0.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 84, n=0,0,1,0	—	—	-1.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Chloride:Week 88, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 1, n=0,0,3,1	—	—	2.337 Percent change Standard Deviation 0.9935	12.820 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 2, n=10,11,12,2	13.449 Percent change Standard Deviation 12.6365	2.836 Percent change Standard Deviation 13.7885	28.843 Percent change Standard Deviation 62.8444	184.385 Percent change Standard Deviation 248.7248
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 3, n=10,11,12,2	3.530 Percent change Standard Deviation 6.0391	3.155 Percent change Standard Deviation 12.3738	12.522 Percent change Standard Deviation 28.5284	10.465 Percent change Standard Deviation 8.7752
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 4, n=10,11,11,2	5.263 Percent change Standard Deviation 13.2032	-0.156 Percent change Standard Deviation 11.9252	11.198 Percent change Standard Deviation 29.2772	6.955 Percent change Standard Deviation 17.3595
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 5, n=10,11,10,1	10.460 Percent change Standard Deviation 13.3237	-0.302 Percent change Standard Deviation 13.6521	7.088 Percent change Standard Deviation 13.6665	-8.510 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 8, n=9,10,10,1	4.977 Percent change Standard Deviation 8.1992	-4.440 Percent change Standard Deviation 10.4367	4.750 Percent change Standard Deviation 7.8635	-15.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 12, n=7,10,7,1	13.411 Percent change Standard Deviation 24.2292	-1.289 Percent change Standard Deviation 11.0396	2.236 Percent change Standard Deviation 6.1696	-13.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 16, n=8,8,4,1	7.920 Percent change Standard Deviation 16.3323	-5.519 Percent change Standard Deviation 12.7681	2.875 Percent change Standard Deviation 5.2082	-6.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 20, n=5,6,4,1	8.414 Percent change Standard Deviation 5.0623	-3.007 Percent change Standard Deviation 13.8034	10.315 Percent change Standard Deviation 5.7571	-2.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 24, n=5,5,3,1	14.184 Percent change Standard Deviation 9.4608	-11.006 Percent change Standard Deviation 15.9134	4.737 Percent change Standard Deviation 4.2811	-5.320 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 28, n=5,4,3,1	12.888 Percent change Standard Deviation 6.5007	-12.093 Percent change Standard Deviation 14.6604	2.520 Percent change Standard Deviation 8.4940	-1.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 32, n=4,3,3,1	11.690 Percent change Standard Deviation 5.1478	-17.913 Percent change Standard Deviation 11.8535	11.320 Percent change Standard Deviation 14.2430	-7.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 36, n=3,1,3,1	10.500 Percent change Standard Deviation 5.7663	-30.530 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.153 Percent change Standard Deviation 53.5998	-18.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 40, n=1,2,2,1	20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-13.230 Percent change Standard Deviation 27.4357	-0.245 Percent change Standard Deviation 2.0294	-12.770 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 44, n=1,2,2,0	-6.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-13.775 Percent change Standard Deviation 17.7413	8.470 Percent change Standard Deviation 4.8508	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 48, n=1,1,1,0	6.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 52, n=1,1,1,0	7.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.680 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 60, n=1,1,1,0	15.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	7.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 64, n=1,1,1,0	5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	29.630 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.520 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 68, n=1,0,1,0	-2.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-0.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 72, n=0,0,1,0	—	—	0.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 76, n=0,0,1,0	—	—	-8.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 80, n=0,0,1,0	—	—	-0.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 84, n=0,0,1,0	—	—	-0.840 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Creatinine:Week 88, n=0,0,1,0	—	—	-13.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 1, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 2, n=4,4,6,1	6.250 Percent change Standard Deviation 65.7489	-11.668 Percent change Standard Deviation 23.3350	-16.538 Percent change Standard Deviation 40.5105	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 3, n=3,2,6,1	-16.667 Percent change Standard Deviation 28.8675	0.000 Percent change Standard Deviation 0.0000	-16.538 Percent change Standard Deviation 40.5105	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 4, n=3,6,6,1	-16.667 Percent change Standard Deviation 28.8675	3.333 Percent change Standard Deviation 32.0416	0.128 Percent change Standard Deviation 63.0024	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 5, n=3,6,5,0	-33.333 Percent change Standard Deviation 28.8675	-8.888 Percent change Standard Deviation 14.4005	-19.846 Percent change Standard Deviation 44.3770	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 8, n=3,5,4,0	-33.333 Percent change Standard Deviation 38.1881	76.000 Percent change Standard Deviation 133.7161	25.000 Percent change Standard Deviation 50.0000	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 12, n=1,5,3,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	60.000 Percent change Standard Deviation 134.1641	0.257 Percent change Standard Deviation 99.6152	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 16, n=2,4,2,0	-50.000 Percent change Standard Deviation 35.3553	20.000 Percent change Standard Deviation 54.1603	-49.615 Percent change Standard Deviation 70.1662	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 20, n=0,2,1,0	—	0.000 Percent change Standard Deviation 0.0000	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 24, n=0,3,1,0	—	-13.333 Percent change Standard Deviation 23.0940	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 28, n=0,1,1,0	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 32, n=0,2,1,0	—	-10.000 Percent change Standard Deviation 14.1421	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 36, n=0,1,1,0	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 40, n=0,2,0,0	—	-10.000 Percent change Standard Deviation 14.1421	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 44, n=0,1,0,0	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 48, n=0,1,0,0	—	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 56, n=0,1,1,0	—	-80.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 60, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 64, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 68, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 76, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 80, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 84, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Direct bilirubin:Week 88, n=0,0,1,0	—	—	-99.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 1, n=0,0,2,1	—	—	25.745 Percent change Standard Deviation 36.4089	40.630 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 2, n=11,10,12,2	-11.921 Percent change Standard Deviation 14.9844	1.494 Percent change Standard Deviation 21.6112	-0.500 Percent change Standard Deviation 13.1110	8.005 Percent change Standard Deviation 4.8861
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 3, n=10,10,11,2	-4.956 Percent change Standard Deviation 15.0667	1.229 Percent change Standard Deviation 19.6823	2.856 Percent change Standard Deviation 23.3024	35.985 Percent change Standard Deviation 3.7547
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 4, n=9,10,10,2	-5.273 Percent change Standard Deviation 9.5191	4.053 Percent change Standard Deviation 31.5693	-0.019 Percent change Standard Deviation 11.9348	17.190 Percent change Standard Deviation 11.0450
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 5, n=9,11,9,0	-2.012 Percent change Standard Deviation 6.5775	-2.482 Percent change Standard Deviation 15.7553	1.737 Percent change Standard Deviation 11.7985	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 8, n=9,10,9,0	-5.971 Percent change Standard Deviation 8.3770	-4.807 Percent change Standard Deviation 11.4303	-2.250 Percent change Standard Deviation 8.1208	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 12, n=6,10,7,1	-4.812 Percent change Standard Deviation 6.3454	-3.481 Percent change Standard Deviation 19.7216	2.353 Percent change Standard Deviation 6.2058	18.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 16, n=8,8,4,1	-2.948 Percent change Standard Deviation 8.0302	-5.276 Percent change Standard Deviation 10.6100	2.220 Percent change Standard Deviation 10.1362	15.910 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 20, n=5,6,4,1	2.184 Percent change Standard Deviation 7.8557	0.290 Percent change Standard Deviation 29.4058	-4.715 Percent change Standard Deviation 17.9623	13.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 24, n=5,5,3,1	-4.902 Percent change Standard Deviation 14.4657	3.640 Percent change Standard Deviation 22.3870	3.997 Percent change Standard Deviation 9.6952	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 28, n=5,4,3,1	-0.288 Percent change Standard Deviation 12.2744	11.950 Percent change Standard Deviation 23.9058	3.610 Percent change Standard Deviation 8.7790	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 32, n=4,3,3,1	3.148 Percent change Standard Deviation 21.6666	-13.227 Percent change Standard Deviation 15.6650	0.363 Percent change Standard Deviation 2.7655	2.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 36, n=3,1,3,1	0.247 Percent change Standard Deviation 4.2508	20.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.320 Percent change Standard Deviation 9.2103	13.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 40, n=1,1,2,1	18.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.310 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.485 Percent change Standard Deviation 8.9308	22.730 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 44, n=1,2,2,0	17.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.955 Percent change Standard Deviation 6.2438	3.485 Percent change Standard Deviation 8.9308	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 48, n=1,1,1,0	13.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.620 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 52, n=1,1,1,0	7.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.540 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 56, n=1,1,1,0	-6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.420 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	5.660 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 60, n=1,1,1,0	2.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.930 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.890 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 64, n=1,1,1,0	-3.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	15.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 68, n=1,0,1,0	10.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-0.940 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 72, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 76, n=0,0,1,0	—	—	9.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 80, n=0,0,1,0	—	—	-2.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 84, n=0,0,1,0	—	—	-2.830 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Glucose:Week 88, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 8, n=3,8,3,0	16.287 Percent change Standard Deviation 3.9830	46.694 Percent change Standard Deviation 62.1149	21.137 Percent change Standard Deviation 14.3265	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 12, n=2,8,4,0	12.870 Percent change Standard Deviation 3.0123	39.709 Percent change Standard Deviation 54.5987	31.353 Percent change Standard Deviation 17.3375	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 16, n=2,6,3,1	14.965 Percent change Standard Deviation 10.5571	53.818 Percent change Standard Deviation 83.5554	37.677 Percent change Standard Deviation 22.5797	36.870 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 20, n=2,5,3,1	13.145 Percent change Standard Deviation 7.9832	7.232 Percent change Standard Deviation 21.7161	35.440 Percent change Standard Deviation 24.8959	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 24, n=2,4,2,1	13.415 Percent change Standard Deviation 5.7064	81.540 Percent change Standard Deviation 74.2387	22.745 Percent change Standard Deviation 2.9486	20.280 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 28, n=2,3,1,1	10.485 Percent change Standard Deviation 5.0982	24.857 Percent change Standard Deviation 27.3567	26.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	18.890 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 32, n=2,3,1,1	14.000 Percent change Standard Deviation 16.2635	63.040 Percent change Standard Deviation 60.6775	13.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	33.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 36, n=2,1,0,1	20.795 Percent change Standard Deviation 16.1432	38.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	12.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 40, n=0,2,0,1	—	75.840 Percent change Standard Deviation 84.5983	—	11.980 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 44, n=0,2,0,0	—	31.175 Percent change Standard Deviation 79.3586	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 48, n=0,1,0,0	—	80.800 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 52, n=0,1,0,0	—	-42.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 56, n=0,1,0,0	—	-44.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 60, n=0,1,0,0	—	-41.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Lactate dehydrogenase:Week 64, n=0,1,0,0	—	-49.130 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 1, n=0,0,3,0	—	—	-2.013 Percent change Standard Deviation 10.2561	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 2, n=9,10,11,2	3.687 Percent change Standard Deviation 10.9267	4.413 Percent change Standard Deviation 5.0742	3.593 Percent change Standard Deviation 13.9856	-3.205 Percent change Standard Deviation 10.3591
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 3, n=8,11,11,2	-1.633 Percent change Standard Deviation 4.7088	6.602 Percent change Standard Deviation 10.8819	-1.808 Percent change Standard Deviation 12.3971	-24.200 Percent change Standard Deviation 32.7673
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 4, n=8,11,10,2	4.104 Percent change Standard Deviation 5.7486	4.971 Percent change Standard Deviation 7.7656	1.254 Percent change Standard Deviation 8.2818	-20.430 Percent change Standard Deviation 15.7685
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 5, n=10,11,9,1	-1.521 Percent change Standard Deviation 6.3803	5.014 Percent change Standard Deviation 12.0008	5.071 Percent change Standard Deviation 8.7326	-7.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 8, n=8,10,9,0	-0.370 Percent change Standard Deviation 5.3051	3.458 Percent change Standard Deviation 6.0669	3.469 Percent change Standard Deviation 7.9381	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 12, n=7,10,7,1	0.904 Percent change Standard Deviation 3.4827	1.288 Percent change Standard Deviation 10.5039	-1.844 Percent change Standard Deviation 7.2017	-3.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 16, n=8,8,4,1	4.311 Percent change Standard Deviation 5.1089	0.045 Percent change Standard Deviation 10.0780	-3.303 Percent change Standard Deviation 9.9862	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 20, n=5,6,4,1	-2.720 Percent change Standard Deviation 6.2671	3.043 Percent change Standard Deviation 6.1070	-5.430 Percent change Standard Deviation 4.0591	-2.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 24, n=5,5,3,1	-1.790 Percent change Standard Deviation 6.7929	1.390 Percent change Standard Deviation 11.0108	-5.453 Percent change Standard Deviation 1.6991	-5.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 28, n=5,3,3,1	-0.512 Percent change Standard Deviation 3.6523	9.137 Percent change Standard Deviation 12.3852	-5.433 Percent change Standard Deviation 7.6708	-9.280 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 32, n=4,3,3,1	-0.303 Percent change Standard Deviation 3.0947	9.400 Percent change Standard Deviation 15.8067	-2.843 Percent change Standard Deviation 4.5798	1.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 36, n=3,1,3,1	-2.917 Percent change Standard Deviation 5.0518	13.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.673 Percent change Standard Deviation 3.8829	-3.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 40, n=1,1,2,1	10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	13.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.780 Percent change Standard Deviation 3.9315	-3.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 44, n=1,2,2,0	-5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	2.315 Percent change Standard Deviation 15.5776	0.000 Percent change Standard Deviation 0.0000	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 48, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-13.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 52, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-13.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 56, n=1,1,1,0	-5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 60, n=1,1,1,0	-5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 64, n=1,1,1,0	5.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 68, n=1,0,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 72, n=0,0,1,0	—	—	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 76, n=0,0,1,0	—	—	-8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 80, n=0,0,1,0	—	—	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 84, n=0,0,1,0	—	—	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Magnesium:Week 88, n=0,0,1,0	—	—	-17.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 1, n=0,0,3,1	—	—	2.560 Percent change Standard Deviation 4.7011	10.870 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 2, n=11,11,12,2	6.295 Percent change Standard Deviation 11.2391	0.394 Percent change Standard Deviation 10.9402	-2.844 Percent change Standard Deviation 9.6594	-1.085 Percent change Standard Deviation 13.8381
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 3, n=10,11,12,2	4.095 Percent change Standard Deviation 9.1369	-0.879 Percent change Standard Deviation 5.4861	0.837 Percent change Standard Deviation 7.9003	-10.870 Percent change Standard Deviation 6.1518
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 4, n=10,11,11,2	5.295 Percent change Standard Deviation 12.9147	2.234 Percent change Standard Deviation 10.6975	-2.279 Percent change Standard Deviation 8.2128	-1.085 Percent change Standard Deviation 1.5344
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 5, n=10,11,10,1	0.613 Percent change Standard Deviation 13.4203	3.677 Percent change Standard Deviation 8.4593	0.479 Percent change Standard Deviation 6.7468	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 8, n=9,10,10,1	3.551 Percent change Standard Deviation 10.1989	-0.714 Percent change Standard Deviation 10.4143	-2.574 Percent change Standard Deviation 8.8434	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 12, n=6,10,7,1	6.910 Percent change Standard Deviation 7.7994	0.801 Percent change Standard Deviation 9.1329	0.097 Percent change Standard Deviation 6.5124	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 16, n=8,8,4,1	3.099 Percent change Standard Deviation 11.1450	0.391 Percent change Standard Deviation 7.4310	0.825 Percent change Standard Deviation 7.0552	4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 20, n=5,6,4,1	7.054 Percent change Standard Deviation 6.5355	-1.055 Percent change Standard Deviation 8.0880	3.608 Percent change Standard Deviation 7.3186	-2.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 24, n=5,5,3,1	4.250 Percent change Standard Deviation 15.2421	-2.684 Percent change Standard Deviation 11.5575	2.383 Percent change Standard Deviation 2.4420	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 28, n=5,4,3,1	4.134 Percent change Standard Deviation 13.7038	-1.040 Percent change Standard Deviation 11.5877	1.793 Percent change Standard Deviation 7.5585	-4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 32, n=4,3,3,1	10.555 Percent change Standard Deviation 11.6304	2.973 Percent change Standard Deviation 14.6875	-3.143 Percent change Standard Deviation 2.7272	4.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 36, n=3,1,3,1	5.650 Percent change Standard Deviation 12.0712	18.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.253 Percent change Standard Deviation 5.6349	-6.520 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 40, n=1,2,2,1	17.070 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.265 Percent change Standard Deviation 7.2761	-2.440 Percent change Standard Deviation 3.4507	-8.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 44, n=1,2,2,0	12.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	10.550 Percent change Standard Deviation 8.0186	5.935 Percent change Standard Deviation 1.9587	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 48, n=1,1,1,0	24.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.880 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 52, n=1,1,1,0	24.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 56, n=1,1,1,0	-2.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 60, n=1,1,1,0	12.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.550 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 64, n=1,1,1,0	24.390 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-4.550 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 68, n=1,0,1,0	29.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	2.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 72, n=0,0,1,0	—	—	-2.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 76, n=0,0,1,0	—	—	-4.550 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 80, n=0,0,1,0	—	—	4.550 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 84, n=0,0,1,0	—	—	-2.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Potassium:Week 88, n=0,0,1,0	—	—	-6.820 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 1, n=0,0,3,1	—	—	-1.657 Percent change Standard Deviation 2.2823	2.860 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 2, n=11,11,12,2	0.013 Percent change Standard Deviation 1.8096	-0.370 Percent change Standard Deviation 1.9173	0.266 Percent change Standard Deviation 1.7336	0.000 Percent change Standard Deviation 2.0223
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 3, n=10,11,12,2	0.311 Percent change Standard Deviation 1.8340	0.009 Percent change Standard Deviation 1.5263	0.308 Percent change Standard Deviation 1.6247	1.430 Percent change Standard Deviation 2.0223
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 4, n=10,11,11,2	0.383 Percent change Standard Deviation 1.4528	-0.178 Percent change Standard Deviation 1.9638	0.545 Percent change Standard Deviation 1.5916	0.710 Percent change Standard Deviation 0.0000
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 5, n=10,11,10,1	0.890 Percent change Standard Deviation 1.2598	-0.255 Percent change Standard Deviation 1.2916	-0.791 Percent change Standard Deviation 1.5272	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 8, n=9,10,10,1	0.312 Percent change Standard Deviation 1.9462	-0.132 Percent change Standard Deviation 1.5679	-0.643 Percent change Standard Deviation 1.5180	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 12, n=6,10,7,1	0.597 Percent change Standard Deviation 1.2596	0.080 Percent change Standard Deviation 1.3734	-0.816 Percent change Standard Deviation 1.0457	2.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 16, n=8,8,4,1	0.643 Percent change Standard Deviation 1.4831	0.009 Percent change Standard Deviation 1.3395	-1.773 Percent change Standard Deviation 2.7477	2.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 20, n=5,6,4,1	1.904 Percent change Standard Deviation 1.3431	0.722 Percent change Standard Deviation 0.6509	-0.173 Percent change Standard Deviation 1.2213	-0.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 24, n=5,5,3,1	0.584 Percent change Standard Deviation 1.4250	-0.424 Percent change Standard Deviation 1.5620	-0.953 Percent change Standard Deviation 0.4215	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 28, n=5,4,3,1	1.606 Percent change Standard Deviation 0.9562	-0.538 Percent change Standard Deviation 0.3584	-0.237 Percent change Standard Deviation 1.4852	-0.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 32, n=4,3,3,1	0.363 Percent change Standard Deviation 0.9515	0.953 Percent change Standard Deviation 1.8133	-0.233 Percent change Standard Deviation 1.4932	-0.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 36, n=3,1,3,1	0.737 Percent change Standard Deviation 1.4550	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.237 Percent change Standard Deviation 0.4099	2.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 40, n=1,2,2,1	2.960 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.385 Percent change Standard Deviation 5.0134	-1.070 Percent change Standard Deviation 1.5132	1.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 44, n=1,2,2,0	2.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.350 Percent change Standard Deviation 0.4950	0.725 Percent change Standard Deviation 2.0294	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 48, n=1,1,1,0	2.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	4.320 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 52, n=1,1,1,0	2.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 56, n=1,1,1,0	3.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 60, n=1,1,1,0	2.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 64, n=1,1,1,0	2.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.160 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 68, n=1,0,1,0	3.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 72, n=0,0,1,0	—	—	-0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 76, n=0,0,1,0	—	—	0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 80, n=0,0,1,0	—	—	0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 84, n=0,0,1,0	—	—	-0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Sodium:Week 88, n=0,0,1,0	—	—	-0.720 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 1, n=0,0,3,1	—	—	-42.590 Percent change Standard Deviation 8.4876	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 2, n=11,11,12,2	-14.740 Percent change Standard Deviation 19.0474	-12.683 Percent change Standard Deviation 35.0603	-0.972 Percent change Standard Deviation 48.2811	-47.220 Percent change Standard Deviation 3.9315
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 3, n=10,11,12,2	-14.679 Percent change Standard Deviation 18.3507	-1.768 Percent change Standard Deviation 31.6024	-10.532 Percent change Standard Deviation 29.0132	-6.945 Percent change Standard Deviation 25.5336
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 4, n=10,11,11,2	-2.488 Percent change Standard Deviation 26.5820	24.492 Percent change Standard Deviation 57.3828	2.855 Percent change Standard Deviation 25.9280	12.500 Percent change Standard Deviation 17.6777
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 5, n=10,11,10,1	-0.500 Percent change Standard Deviation 19.7836	12.879 Percent change Standard Deviation 40.0010	13.944 Percent change Standard Deviation 48.2067	-22.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 8, n=9,10,10,1	-3.744 Percent change Standard Deviation 22.8000	45.680 Percent change Standard Deviation 62.1644	21.972 Percent change Standard Deviation 40.2576	-55.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 12, n=7,10,7,1	-6.276 Percent change Standard Deviation 27.3764	20.223 Percent change Standard Deviation 39.6273	4.364 Percent change Standard Deviation 18.2751	-44.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 16, n=8,8,4,1	-5.739 Percent change Standard Deviation 13.8572	16.473 Percent change Standard Deviation 48.6051	-4.165 Percent change Standard Deviation 20.9713	-44.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 20, n=5,6,4,1	4.454 Percent change Standard Deviation 23.8194	-15.500 Percent change Standard Deviation 23.5242	-15.973 Percent change Standard Deviation 11.1972	-22.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 24, n=5,5,3,1	-14.500 Percent change Standard Deviation 8.7321	-0.714 Percent change Standard Deviation 56.6292	-19.443 Percent change Standard Deviation 17.3459	-11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 28, n=5,4,3,1	-3.182 Percent change Standard Deviation 22.6771	-4.165 Percent change Standard Deviation 20.9713	0.000 Percent change Standard Deviation 0.0000	-22.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 32, n=4,3,3,1	-12.215 Percent change Standard Deviation 23.6747	-13.890 Percent change Standard Deviation 12.7297	1.853 Percent change Standard Deviation 13.9824	-33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 36, n=3,1,3,1	9.167 Percent change Standard Deviation 18.7639	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.963 Percent change Standard Deviation 11.5645	-44.440 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 40, n=1,2,2,1	-37.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-16.665 Percent change Standard Deviation 23.5679	-25.000 Percent change Standard Deviation 35.3553	-55.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 44, n=1,2,2,0	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	8.335 Percent change Standard Deviation 58.9232	-18.055 Percent change Standard Deviation 9.8217	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 48, n=1,1,1,0	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-16.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 52, n=1,1,1,0	-12.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 56, n=1,1,1,0	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 60, n=1,1,1,0	-37.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-66.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 64, n=1,1,1,0	-37.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-66.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 68, n=1,0,1,0	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 72, n=0,0,1,0	—	—	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 76, n=0,0,1,0	—	—	-25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 80, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 84, n=0,0,1,0	—	—	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total bilirubin:Week 88, n=0,0,1,0	—	—	50.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 1, n=0,0,3,1	—	—	1.380 Percent change Standard Deviation 2.8026	3.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 2, n=11,11,12,1	2.140 Percent change Standard Deviation 7.3161	-14.885 Percent change Standard Deviation 32.7433	82.059 Percent change Standard Deviation 278.6333	-1.590 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 3, n=10,11,12,2	-2.260 Percent change Standard Deviation 5.4555	-5.132 Percent change Standard Deviation 18.9226	60.186 Percent change Standard Deviation 206.7731	-0.110 Percent change Standard Deviation 2.0930
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 4, n=10,10,11,2	-0.132 Percent change Standard Deviation 4.5645	-5.886 Percent change Standard Deviation 18.8830	-0.086 Percent change Standard Deviation 4.6004	-9.090 Percent change Standard Deviation 5.1053
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 5, n=9,11,10,0	-8.962 Percent change Standard Deviation 26.1684	-5.207 Percent change Standard Deviation 16.4970	1.943 Percent change Standard Deviation 6.8329	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 8, n=8,10,10,0	0.981 Percent change Standard Deviation 3.3039	-7.914 Percent change Standard Deviation 16.5027	2.247 Percent change Standard Deviation 6.1649	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 12, n=7,10,7,1	0.570 Percent change Standard Deviation 5.5899	-7.764 Percent change Standard Deviation 17.4075	1.009 Percent change Standard Deviation 4.6858	-2.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 16, n=8,8,4,1	0.336 Percent change Standard Deviation 6.3130	-10.768 Percent change Standard Deviation 17.9309	-4.268 Percent change Standard Deviation 6.0907	5.480 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 20, n=5,6,3,1	-1.520 Percent change Standard Deviation 7.6530	-2.397 Percent change Standard Deviation 4.8249	2.390 Percent change Standard Deviation 3.3674	4.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 24, n=5,5,3,1	-0.368 Percent change Standard Deviation 6.3631	-1.748 Percent change Standard Deviation 6.0092	-3.713 Percent change Standard Deviation 7.2790	2.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 28, n=5,4,3,1	0.168 Percent change Standard Deviation 5.4900	-3.243 Percent change Standard Deviation 3.2436	0.000 Percent change Standard Deviation 6.2070	4.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 32, n=4,3,3,1	0.490 Percent change Standard Deviation 6.4817	-4.220 Percent change Standard Deviation 1.4543	-1.160 Percent change Standard Deviation 12.5647	2.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 36, n=2,1,3,1	-0.580 Percent change Standard Deviation 2.9981	-3.170 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.447 Percent change Standard Deviation 4.3016	4.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 40, n=1,2,2,1	-4.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.935 Percent change Standard Deviation 11.2218	-7.115 Percent change Standard Deviation 8.1247	-2.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 44, n=1,2,2,0	-1.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.380 Percent change Standard Deviation 2.2062	-0.205 Percent change Standard Deviation 13.8522	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 48, n=1,1,1,0	-5.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.200 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-11.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 52, n=1,1,1,0	-2.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 56, n=1,1,1,0	-6.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-9.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 60, n=1,1,1,0	-2.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-6.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 64, n=1,1,1,0	-6.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-9.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-8.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 68, n=1,0,1,0	-5.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-11.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 72, n=0,0,1,0	—	—	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 76, n=0,0,1,0	—	—	-17.140 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 80, n=0,0,1,0	—	—	-8.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 84, n=0,0,1,0	—	—	-5.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters in Combination Treatment Period:ALT, Albumin, ALP, AST, Calcium, CO2, Chloride, Creatinine, Direct Bilirubin, Glucose, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein Total protein:Week 88, n=0,0,1,0	—	—	-11.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—

PRIMARY outcome

Timeframe: Baseline (Day 1), Weeks 1, 2,3,4,5,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84 and 88

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected to analyze the chemistry parameters: BUN and uric acid. Baseline value is the latest GSK2636771 pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100 multiplied by (post-Baseline visit value minus Baseline divided by Baseline).

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=10 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 40, n=1,2,2,1	3.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.970 Percent change Standard Deviation 36.8120	-9.580 Percent change Standard Deviation 1.0748	28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 44, n=1,1,2,0	-12.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	6.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-1.695 Percent change Standard Deviation 12.1552	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 48, n=1,0,1,0	-6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-20.590 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 52, n=1,0,1,0	6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-13.240 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 56, n=1,0,1,0	-6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-4.410 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 60, n=1,0,1,0	9.090 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-1.470 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 64, n=1,0,1,0	-12.120 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-11.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 68, n=1,0,1,0	-6.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-10.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 72, n=0,0,1,0	—	—	-11.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 76, n=0,0,1,0	—	—	-20.590 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 80, n=0,0,1,0	—	—	-14.710 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 84, n=0,0,1,0	—	—	-7.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 88, n=0,0,1,0	—	—	-17.650 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 1, n=0,0,3,1	—	—	-10.227 Percent change Standard Deviation 9.3008	18.180 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 2, n=10,11,12,1	-5.741 Percent change Standard Deviation 24.5046	-7.622 Percent change Standard Deviation 18.4784	1.848 Percent change Standard Deviation 44.3336	236.360 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 3, n=8,11,12,1	-10.699 Percent change Standard Deviation 18.9576	-12.921 Percent change Standard Deviation 8.9324	-9.143 Percent change Standard Deviation 22.4881	45.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 4, n=9,11,11,1	-12.330 Percent change Standard Deviation 16.4809	-13.030 Percent change Standard Deviation 17.8055	-11.637 Percent change Standard Deviation 19.2345	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 5, n=9,11,10,0	-14.012 Percent change Standard Deviation 12.6452	-8.568 Percent change Standard Deviation 18.3100	1.857 Percent change Standard Deviation 19.8509	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 8, n=9,10,10,0	-8.916 Percent change Standard Deviation 22.6106	-16.238 Percent change Standard Deviation 16.8508	-12.537 Percent change Standard Deviation 14.8918	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 12, n=6,10,7,0	0.090 Percent change Standard Deviation 20.4882	-12.186 Percent change Standard Deviation 20.8205	-10.536 Percent change Standard Deviation 18.6180	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 16, n=8,8,4,0	-5.259 Percent change Standard Deviation 14.6735	-18.011 Percent change Standard Deviation 12.0206	-5.560 Percent change Standard Deviation 22.5383	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 20, n=5,6,4,0	-9.110 Percent change Standard Deviation 12.9929	-6.380 Percent change Standard Deviation 21.2869	-6.910 Percent change Standard Deviation 20.6469	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 24, n=5,5,3,0	-4.036 Percent change Standard Deviation 9.0958	-13.412 Percent change Standard Deviation 29.3172	7.450 Percent change Standard Deviation 8.7505	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 28, n=5,4,3,0	-11.508 Percent change Standard Deviation 10.1606	-21.773 Percent change Standard Deviation 9.5686	12.603 Percent change Standard Deviation 15.4411	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 32, n=4,3,3,0	-8.163 Percent change Standard Deviation 11.5276	-7.553 Percent change Standard Deviation 30.6672	-16.567 Percent change Standard Deviation 12.1882	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 36, n=3,1,3,0	-7.593 Percent change Standard Deviation 12.0178	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	1.970 Percent change Standard Deviation 29.1203	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 40, n=1,2,2,0	16.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	27.885 Percent change Standard Deviation 90.2056	-7.275 Percent change Standard Deviation 3.8537	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 44, n=1,2,2,0	-5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-26.285 Percent change Standard Deviation 13.5977	-6.060 Percent change Standard Deviation 15.0048	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 48, n=1,1,1,0	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-17.950 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 52, n=1,1,1,0	5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-23.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 56, n=1,1,1,0	-22.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-30.770 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 60, n=1,1,1,0	55.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-7.690 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-23.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 64, n=1,1,1,0	5.560 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-15.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-16.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 68, n=1,0,1,0	-11.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	-26.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 72, n=0,0,1,0	—	—	-23.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 76, n=0,0,1,0	—	—	-20.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 80, n=0,0,1,0	—	—	-26.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 84, n=0,0,1,0	—	—	-10.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid BUN:Week 88, n=0,0,1,0	—	—	-70.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 1, n=0,0,3,0	—	—	6.513 Percent change Standard Deviation 3.2031	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 2, n=8,10,11,2	-11.656 Percent change Standard Deviation 33.0629	158.135 Percent change Standard Deviation 499.1483	13.357 Percent change Standard Deviation 26.0799	71.090 Percent change Standard Deviation 46.6549
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 3, n=7,9,11,2	-4.581 Percent change Standard Deviation 14.8856	154.651 Percent change Standard Deviation 480.5708	0.284 Percent change Standard Deviation 14.9816	25.170 Percent change Standard Deviation 38.4808
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 4, n=7,11,10,1	1.053 Percent change Standard Deviation 12.8059	-3.509 Percent change Standard Deviation 7.9426	4.436 Percent change Standard Deviation 22.8767	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 5, n=9,11,9,0	1.676 Percent change Standard Deviation 8.0283	139.415 Percent change Standard Deviation 481.0482	0.532 Percent change Standard Deviation 10.9365	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 8, n=8,10,9,0	3.543 Percent change Standard Deviation 16.5957	-7.224 Percent change Standard Deviation 9.7223	0.440 Percent change Standard Deviation 10.9092	—
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 12, n=6,10,6,1	4.578 Percent change Standard Deviation 19.8500	-1.403 Percent change Standard Deviation 5.7519	-0.210 Percent change Standard Deviation 12.5985	28.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 16, n=8,8,4,1	3.146 Percent change Standard Deviation 8.8330	-7.384 Percent change Standard Deviation 8.5001	-3.473 Percent change Standard Deviation 5.4805	52.380 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 20, n=5,5,4,1	2.232 Percent change Standard Deviation 5.4135	-1.796 Percent change Standard Deviation 8.1659	1.920 Percent change Standard Deviation 10.9245	38.100 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 24, n=5,5,3,1	2.570 Percent change Standard Deviation 10.5697	-14.008 Percent change Standard Deviation 11.1139	-2.893 Percent change Standard Deviation 5.4966	19.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 28, n=5,2,3,1	2.062 Percent change Standard Deviation 14.6021	-6.000 Percent change Standard Deviation 8.4853	-6.387 Percent change Standard Deviation 5.5830	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 32, n=4,3,3,1	8.103 Percent change Standard Deviation 17.4601	0.243 Percent change Standard Deviation 27.6106	-3.767 Percent change Standard Deviation 9.2418	14.290 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Chemistry Parameters During Combination Treatment Period: Blood Urea Nitrogen (BUN), Uric Acid Uric acid:Week 36, n=3,1,3,1	0.723 Percent change Standard Deviation 13.2198	42.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-2.957 Percent change Standard Deviation 6.4150	9.520 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.

PRIMARY outcome

Timeframe: Baseline (Day 1), Weeks 1, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56 and 64

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Urine samples were collected to analyze the urinalysis parameters: Calcium, Creatinine concentration (conc), Magnesium, Phosphate and Protein. Baseline value is the latest GSK2636771 pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100 multiplied by (post-Baseline visit value minus Baseline divided by Baseline).

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=9 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=7 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=6 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 32, n=2,0,0,0	45.985 Percent change Standard Deviation 16.6524	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 36, n=1,0,1,1	28.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	11.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-23.400 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Calcium, Week 1, n=0,0,3,0	—	—	-65.187 Percent change Standard Deviation 18.5760	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Calcium, Week 3, n=8,4,5,1	-17.766 Percent change Standard Deviation 84.7647	-46.473 Percent change Standard Deviation 32.8568	-54.754 Percent change Standard Deviation 23.2351	-95.740 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 4, n=6,7,6,2	1.833 Percent change Standard Deviation 85.3207	-43.770 Percent change Standard Deviation 21.3110	-38.720 Percent change Standard Deviation 37.1828	-87.880 Percent change Standard Deviation 9.6167
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 8, n=7,6,5,0	-22.406 Percent change Standard Deviation 106.2823	-39.052 Percent change Standard Deviation 24.6041	-38.834 Percent change Standard Deviation 33.0068	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 16, n=7,6,3,1	-15.649 Percent change Standard Deviation 92.8636	-41.387 Percent change Standard Deviation 16.7494	-39.437 Percent change Standard Deviation 47.6551	-54.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 24, n=5,4,1,1	-18.746 Percent change Standard Deviation 63.7505	-35.570 Percent change Standard Deviation 56.9229	-80.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	32.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 32, n=4,1,1,1	-21.723 Percent change Standard Deviation 80.8076	-28.700 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-57.450 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-70.270 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 40, n=1,1,1,1	7.690 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-69.500 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	3.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 48, n=1,1,0,0	63.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-69.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 56, n=1,1,0,0	149.230 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-42.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine calcium, Week 64, n=1,0,0,0	13.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 4, n=3,2,2,0	-4.953 Percent change Standard Deviation 32.2945	-2.095 Percent change Standard Deviation 44.4699	-28.210 Percent change Standard Deviation 26.3609	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 8, n=4,2,2,0	-6.328 Percent change Standard Deviation 17.8300	-6.815 Percent change Standard Deviation 21.1071	-28.420 Percent change Standard Deviation 14.5947	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 12, n=2,2,2,0	23.965 Percent change Standard Deviation 75.8372	55.315 Percent change Standard Deviation 124.3447	-68.290 Percent change Standard Deviation 30.3207	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 16, n=1,2,1,0	87.930 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-38.040 Percent change Standard Deviation 15.3725	-38.920 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 20, n=3,2,1,0	34.260 Percent change Standard Deviation 62.0584	-56.830 Percent change Standard Deviation 14.2694	-56.760 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 24, n=2,1,0,0	14.140 Percent change Standard Deviation 43.4022	-15.730 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 28, n=3,0,0,0	-39.680 Percent change Standard Deviation 53.3702	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Creatinine conc, Week 40, n=0,0,1,1	—	—	-67.570 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-16.490 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 3, n=5,3,3,0	-3.814 Percent change Standard Deviation 33.8771	-22.173 Percent change Standard Deviation 21.2675	-25.617 Percent change Standard Deviation 41.4271	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 4, n=5,4,3,0	-18.914 Percent change Standard Deviation 34.9200	48.198 Percent change Standard Deviation 36.5733	-38.777 Percent change Standard Deviation 21.3399	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 8, n=4,4,3,0	0.080 Percent change Standard Deviation 97.5606	22.425 Percent change Standard Deviation 45.1613	-46.677 Percent change Standard Deviation 18.8832	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 16, n=2,3,0,0	33.510 Percent change Standard Deviation 124.1680	4.530 Percent change Standard Deviation 17.5296	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 24, n=3,2,0,0	-13.997 Percent change Standard Deviation 66.1097	8.425 Percent change Standard Deviation 50.4804	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 32, n=3,1,0,0	4.147 Percent change Standard Deviation 77.8921	82.350 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 40, n=1,0,0,0	-77.050 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 48, n=1,0,0,0	47.540 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 56, n=1,0,0,0	-13.110 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Magnesium, Week 64, n=1,0,0,0	19.670 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 1, n=0,0,2,0	—	—	7.800 Percent change Standard Deviation 18.9646	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 3, n=8,4,5,0	9.118 Percent change Standard Deviation 45.4234	41.553 Percent change Standard Deviation 63.8281	12.918 Percent change Standard Deviation 59.9265	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 4, n=9,6,5,1	1.980 Percent change Standard Deviation 50.5354	55.768 Percent change Standard Deviation 99.4820	-13.832 Percent change Standard Deviation 24.3081	-57.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 8, n=7,7,4,0	30.650 Percent change Standard Deviation 76.2619	61.757 Percent change Standard Deviation 109.4144	-0.638 Percent change Standard Deviation 28.7487	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 16, n=6,5,2,1	23.998 Percent change Standard Deviation 77.8683	60.884 Percent change Standard Deviation 85.7357	52.270 Percent change Standard Deviation 74.6422	29.060 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 24, n=5,3,1,1	84.308 Percent change Standard Deviation 119.7584	25.007 Percent change Standard Deviation 76.8139	-23.470 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-0.990 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 32, n=4,2,1,1	48.388 Percent change Standard Deviation 121.3648	-22.530 Percent change Standard Deviation 15.2735	-2.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-65.020 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 40, n=1,1,1,1	0.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-39.080 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-3.030 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-12.320 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 48, n=1,0,0,0	222.220 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 56, n=1,0,0,0	-48.150 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Phosphate, Week 64, n=1,0,0,0	37.040 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 4, n=0,1,0,0	—	-13.790 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 12, n=0,0,1,0	—	—	-53.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 16, n=0,1,1,0	—	-6.900 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	-30.770 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 20, n=0,0,1,0	—	—	-53.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 24, n=0,1,0,0	—	-12.640 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 28, n=1,0,0,0	-99.430 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 32, n=1,0,0,0	-34.780 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 36, n=0,0,1,1	—	—	38.460 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	33.330 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.
Percent Change From Baseline in Urine Concentration of Calcium, Creatinine Concentration, Magnesium, Phosphate, Protein During Combination Treatment Period Urine Protein, Week 40, n=0,0,1,1	—	—	-53.850 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.	25.000 Percent change Standard Deviation NA Standard deviation could not be calculated for single participant.

PRIMARY outcome

Timeframe: Weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80 and 88

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

A 12-lead ECG was obtained after the participant had rested at least 5 minutes in a semi-recumbent or supine position at each time point during the study using ECG machine that automatically measured PR, QRS, QT and Corrected QT interval (QT duration corrected for heart rate by Bazett's formula \[QTcB\] and Fridericia's formula \[QTcF\]). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinical significant ECG findings are presented.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=10 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=9 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=11 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 16, n=8,8,3,1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 24, n=5,5,3,1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 4, n=10,8,11,1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 8, n=8,9,8,0	0 Participants	1 Participants	1 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 32, n=4,3,3,1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 40, n=1,0,2,1	0 Participants	—	0 Participants	0 Participants
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 48, n=1,1,1,0	0 Participants	0 Participants	0 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 56, n=1,0,1,0	0 Participants	—	0 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 64, n=1,0,1,0	0 Participants	—	0 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 72, n=0,0,1,0	—	—	0 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 80, n=0,0,1,0	—	—	0 Participants	—
Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings During Combination Treatment Period Week 88, n=0,0,1,0	—	—	0 Participants	—

PRIMARY outcome

Timeframe: Up to maximum 654 days

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed.

SBP and DBP were measured after resting for 5 minutes in semi-supine position. SBP and DBP were graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4. 'Any grade increase' is defined as an increase in CTCAE grade relative to Baseline grade. For SBP, Grade 0: \<120 millimeters of mercury \[mmHg\]), Grade 1: 120-139 mmHg, Grade 2: 140-159 mmHg, Grade 3:\>=160 mmHg. For DBP, Grade 0: \<80 mmHg, Grade 1: 80-89 mmHg, Grade 2: 90-99 mmHg, Grade 3: \>=100 mmHg. Higher grade indicate worst outcome. Data for worst-case post-Baseline is reported.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period SBP, Any Grade Increase	8 Participants	6 Participants	5 Participants	1 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period SBP, Increase to Grade 2	3 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period SBP, Increase to Grade 3	3 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period DBP, Any Grade Increase	8 Participants	6 Participants	5 Participants	2 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period DBP, Increase to Grade 2	6 Participants	4 Participants	2 Participants	1 Participants
Number of Participants With Worst Case Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Results by Maximum Grade Increase Post-Baseline Relative to Baseline During Combination Treatment Period DBP, Increase to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to maximum 654 days

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed.

Heart rate was measured after resting for 5 minutes in semi-supine position. The clinical concern range for heart rate was: low: decrease to \<60 beats per minute (bpm) and high: increase to \>100 bpm. Participants were counted in the worst case category that their value changed to (low, within range or no change, or high) unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the 'Change to normal or No Change' category. Participants were counted twice if the participant had both values 'decrease to \<60 bpm' and 'increase to \>100 bpm' during post-Baseline visits. Data for worst case post-Baseline is reported.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Worst Case Post-Baseline Results for Heart Rate During Combination Treatment Period Decrease to <60	2 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Worst Case Post-Baseline Results for Heart Rate During Combination Treatment Period Change to normal or no change	8 Participants	7 Participants	5 Participants	1 Participants
Number of Participants With Worst Case Post-Baseline Results for Heart Rate During Combination Treatment Period Increase to >100	1 Participants	3 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to maximum 654 days

Population: All Treated Safety Population. Only those participants with data available at the indicated time points were analyzed.

Temperature was measured after resting for 5 minutes in semi-supine position. The clinical concern range for body temperature was: low: decrease to \<=35 degrees celsius, high: increase to \>=38 degrees celsius. Participants were counted in the worst case category that their value changed to (low, within range or no change, or high) unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the 'Change to normal or No Change' category. Participants were counted twice if the participant had both values 'decreased to \<=35 degree celsius' and 'increased to \>=38 degrees celsius' during post-Baseline visits. Data for worst-case post-Baseline is presented.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=10 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Number of Participants With Worst Case Post-Baseline Results for Body Temperature During Combination Treatment Period Decrease to <=35	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Post-Baseline Results for Body Temperature During Combination Treatment Period Change to normal or no change	11 Participants	10 Participants	10 Participants	2 Participants
Number of Participants With Worst Case Post-Baseline Results for Body Temperature During Combination Treatment Period Increase to >=38	0 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: Modified All Treated Clinical Activity Population. The hypothesis for 12-week non-PD rate was to be tested on a combination of data provided in the dose escalation and dose expansion phase. The 200 mg dose was the only one that had a dose expansion phase. Hence, a combined arm of GSK2636771 200 mg/ Enzalutamide 160 mg has been presented.

The 12-week non-PD rate was defined as percentage of participants without progression(non-PD) at Week12 as determined from Prostate-specific antigen(PSA) results, radiographic assessment per Response Evaluation Criteria In Solid Tumors(RECIST)1.1 and bone scan.Disease progression was defined by 1 or more of the following:PSA progression alone; PSA progression according to the PCWG2 criteria with accompanying progression by RECIST1.1 or bone scan for participants with soft tissue Baseline disease; Bone progression on bone scan according to PCWG2 criteria; or Radiographic progression in soft tissue or bone by RECIST1.1 for participants with Baseline disease.Modified All Treated Clinical Activity Population consisted of all participants who received at least 1 dose of GSK2636771 and who were treated at the same dose as dose expansion cohort and have been on study drug for at least 12weeks or have discontinued study treatment due to disease progression, died or withdrawn for any reason.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=22 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Non-progressive Disease (Non-PD) Rate at Week 12 According to Prostate Cancer Working Group 2 (PCWG2) Criteria in GSK2636771 200mg/Enzalutamide 160mg - Overall Arm	50 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: At Week 12

Population: All treated Clinical Activity Population consisted of all participants who received at least one dose of GSK2636771.

PSA50 response rate is defined as percentage of participants with a decrease of \>=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment until last post-treatment follow-up visit or initiation of new anti-cancer therapy and confirmed after 3 or more weeks by an additional PSA evaluation. Confirmed PSA50 is defined as decline of \>=50% in PSA concentration from Baseline.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Prostate-specific Antigen Decrease From Baseline >=50% (PSA50) Response Rate at 12 Weeks During Combination Treatment Period	9 Percentage of participants	9 Percentage of participants	8 Percentage of participants	50 Percentage of participants

SECONDARY outcome

Timeframe: Up to maximum 654 days

Population: All Treated Clinical Activity Population

ORR is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR) as the Best Overall Response (BOR), as assessed by the investigator per RECIST Version (v) 1.1 criteria; where CR: Disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of target lesions with reference to Baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Objective Response Rate (ORR) During Combination Treatment Period PR	9 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Objective Response Rate (ORR) During Combination Treatment Period CR	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to maximum 654 days

Population: All treated Clinical Activity Population. Only those participants with data available at the indicated time points were analyzed.

Time to PSA progression is defined as the time from combination study treatment start until the first PSA progression per PCWG2 criteria (confirmed if there has been a PSA decline from Baseline). Time to PSA was analyzed using Kaplan-Meier methods. Median and inter-quartile range (first and third quartile) are presented.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Time to PSA Progression According to PCWG2 Criteria During Combination Treatment Period	19.1 Weeks Interval 15.1 to 31.1	14.6 Weeks Interval 11.3 to 19.1	11.4 Weeks Interval 11.1 to 19.1	11.9 Weeks As there was a single participant, median value presented is the actual value. Hence, inter quartile range could not be calculated for single participant.

SECONDARY outcome

Timeframe: Up to maximum 654 days

Population: All treated Clinical Activity Population. Only those participants with data available at the indicated time points were analyzed.

Time to radiological progression is defined as the time from combination study treatment start until the first radiological progression by PCWG2 criteria. Time to radiological progession was analyzed using Kaplan-Meier methods. For participants who do not progress, participants were censored at the time of last radiological scan or date of death. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of GSK2636771 drug. Median and inter-quartile range (first and third quartile) are presented.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Time to Radiological Progression According to PCWG2 Criteria During Combination Treatment Period	38.1 Weeks Interval 34.3 to 38.1	23.1 Weeks Interval 11.3 to \<75% of participants experienced the event within the treatment arm and two participants were censored.	21.9 Weeks Interval 14.6 to 43.0	38.9 Weeks As there was a single participant, median value presented is the actual value. Hence, inter quartile range could not be calculated for single participant.

SECONDARY outcome

Timeframe: Up to maximum 654 days

Population: All treated Clinical Activity Population. Only those participants with data available at the indicated time points were analyzed.

rPFS is defined as the interval of time (in weeks) between the date of first dose of GSK2636771 and the earlier of the date of disease progression as assessed by the investigator per RECIST version 1.1 criteria and the date of death due to any cause. For participants who do not progress or die, participants were censored at the time of last radiological scan. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of GSK2636771 drug. rPFS was analyzed using Kaplan-Meier methods. Median and inter-quartile range (first and third quartile) are presented.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=11 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Radiological Progression Free Survival (rPFS) Per PCWG2 Criteria During Combination Treatment Period	38.1 Weeks Interval 34.3 to 38.1	23.1 Weeks Interval 11.3 to \<75% of participants experienced the event within the treatment arm and two participants were censored.	21.9 Weeks Interval 14.6 to 43.0	38.9 Weeks As there was a single participant, median value presented is the actual value. Hence, inter quartile range could not be calculated for single participant.

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 1, 2, 3, 5-6, 6-7, 7-8 hours post-dose; Weeks 8 and 12: Pre-dose

Population: Pharmacokinetic Concentration Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2636771.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=7 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: Pre-dose, n=6	4035.000 Nanograms per milliliter Standard Deviation 2650.9602	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 1 hour, n=6	4758.333 Nanograms per milliliter Standard Deviation 1818.9823	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 2 hours, n=7	7124.286 Nanograms per milliliter Standard Deviation 4328.2362	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 3 hours, n=7	9565.714 Nanograms per milliliter Standard Deviation 4422.4648	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 5-6 hours, n=1	14600.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 6-7 hours, n=1	13400.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 7-8 hours, n=1	14800.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 8: Pre-dose, n=7	6291.429 Nanograms per milliliter Standard Deviation 3742.1492	—	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 12: Pre-dose, n=6	5328.333 Nanograms per milliliter Standard Deviation 2756.5879	—	—	—

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 0.5, 1, 2, 3, 4, 6 hours post-dose; Weeks 8 and 12: Pre-dose

Population: Pharmacokinetic Concentration Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2636771. Pharmacokinetic Concentration Population consisted of all participants in the All Treated Safety Population for whom a blood sample for pharmacokinetics were obtained, analyzed, and was measurable.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=8 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=8 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=1 Participants Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: Pre-dose, n=8,8,1	6720.000 Nanograms per milliliter Standard Deviation 3376.1136	5142.500 Nanograms per milliliter Standard Deviation 1613.1402	0.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 0.5 hours, n=8,6,1	8059.250 Nanograms per milliliter Standard Deviation 4085.9045	5008.333 Nanograms per milliliter Standard Deviation 1170.4771	292.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 1 hours, n=7,7,1	8620.714 Nanograms per milliliter Standard Deviation 4561.6832	5794.286 Nanograms per milliliter Standard Deviation 994.8175	433.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 2 hours, n=8,8,1	8811.875 Nanograms per milliliter Standard Deviation 4424.590	8408.750 Nanograms per milliliter Standard Deviation 1764.7374	3510.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 3 hours, n=8, 8,1	9776.875 Nanograms per milliliter Standard Deviation 4869.5519	10510.000 Nanograms per milliliter Standard Deviation 3375.0725	6690.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 4 hours, n=7,8,1	8921.429 Nanograms per milliliter Standard Deviation 4857.7959	11250.000 Nanograms per milliliter Standard Deviation 3639.5172	9060.000 Nanograms per milliliter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 6 hours, n=6,8,0	7264.833 Nanograms per milliliter Standard Deviation 4319.3051	10073.750 Nanograms per milliliter Standard Deviation 3000.0664	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 8: Pre-dose, n=7,6,0	9354.286 Nanograms per milliliter Standard Deviation 3676.1477	7333.333 Nanograms per milliliter Standard Deviation 4236.7802	—	—
Plasma Concentration of GSK2636771 in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 12: Pre-dose, n=6,5,0	7938.333 Nanograms per milliliter Standard Deviation 3801.3756	8036.000 Nanograms per milliliter Standard Deviation 3025.3479	—	—

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 0.5, 1, 2, 3, 4, 6 hours post-dose; Weeks 8 and 12: Pre-dose

Population: Pharmacokinetic Concentration Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). Blood samples were not collected for analysis of Enzalutamide for GSK2636771 400mg/Enzalutamide 160mg Escalation arm.

Blood samples were collected at indicated time points for pharmacokinetic analysis of enzalutamide.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=9 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=7 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: Pre-dose, n=9,7,0	12.131 Micrograms per milliliter Standard Deviation 3.0795	12.134 Micrograms per milliliter Standard Deviation 3.2382	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 0.5 hours, n=9,6,0	14.178 Micrograms per milliliter Standard Deviation 2.4929	13.545 Micrograms per milliliter Standard Deviation 3.9395	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 1 hours, n=7,7,0	14.771 Micrograms per milliliter Standard Deviation 2.8224	14.829 Micrograms per milliliter Standard Deviation 2.7980	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 2 hours, n=9,7,0	13.611 Micrograms per milliliter Standard Deviation 3.5674	14.200 Micrograms per milliliter Standard Deviation 2.7761	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 3 hours, n=8,7,0	14.600 Micrograms per milliliter Standard Deviation 3.4748	12.586 Micrograms per milliliter Standard Deviation 2.8416	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 4 hours, n=9,7,0	12.536 Micrograms per milliliter Standard Deviation 3.3727	12.466 Micrograms per milliliter Standard Deviation 3.4905	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 6 hours, n=7,7,0	11.741 Micrograms per milliliter Standard Deviation 3.0012	12.150 Micrograms per milliliter Standard Deviation 3.6842	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 8: Pre-dose, n=5,5,0	13.140 Micrograms per milliliter Standard Deviation 2.7337	12.240 Micrograms per milliliter Standard Deviation 2.1126	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 12: Pre-dose, n=4,4,0	12.333 Micrograms per milliliter Standard Deviation 3.8684	12.750 Micrograms per milliliter Standard Deviation 1.6176	—	—

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 1, 2, 3, 5-6, 6-7, 7-8 hours post-dose; Weeks 8 and 12: Pre-dose

Population: Pharmacokinetic Concentration Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for pharmacokinetic analysis of enzalutamide.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=8 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: Pre-dose, n=6	11.735 Micrograms per milliliter Standard Deviation 2.3463	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 1 hour, n=7	14.793 Micrograms per milliliter Standard Deviation 3.8293	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 2 hours, n=7	13.274 Micrograms per milliliter Standard Deviation 2.9788	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 3 hours, n=7	12.886 Micrograms per milliliter Standard Deviation 4.1615	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 5-6 hours, n=2	13.800 Micrograms per milliliter Standard Deviation 0.7071	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 6-7 hours, n=2	13.300 Micrograms per milliliter Standard Deviation 1.4142	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 7-8 hours, n=2	12.750 Micrograms per milliliter Standard Deviation 0.3536	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 8: Pre-dose, n=8	11.335 Micrograms per milliliter Standard Deviation 2.5525	—	—	—
Plasma Concentration of Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 12: Pre-dose, n=6	11.520 Micrograms per milliliter Standard Deviation 3.1956	—	—	—

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 0.5, 1, 2, 3, 4, 6 hours post-dose; Weeks 8 and 12: Pre-dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of N-desmethyl enzalutamide.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=9 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=7 Participants Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: Pre-dose, n=9,7,0	13.057 Micrograms per milliliter Standard Deviation 3.5612	12.583 Micrograms per milliliter Standard Deviation 4.4768	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 0.5 hours, n=9,6,0	13.257 Micrograms per milliliter Standard Deviation 3.0229	12.208 Micrograms per milliliter Standard Deviation 4.9689	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 1 hours, n=7,7,0	12.736 Micrograms per milliliter Standard Deviation 2.6587	11.350 Micrograms per milliliter Standard Deviation 4.4129	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 2 hours, n=9,7,0	11.710 Micrograms per milliliter Standard Deviation 2.7646	11.449 Micrograms per milliliter Standard Deviation 3.9828	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 3 hours, n=8,7,0	13.189 Micrograms per milliliter Standard Deviation 2.5728	11.136 Micrograms per milliliter Standard Deviation 4.4445	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 4 hours, n=9,7,0	11.426 Micrograms per milliliter Standard Deviation 2.1615	10.703 Micrograms per milliliter Standard Deviation 3.5853	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 5: 6 hours, n=7,7,0	11.256 Micrograms per milliliter Standard Deviation 2.6641	10.416 Micrograms per milliliter Standard Deviation 1.7444	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 8: Pre-dose, n=5,5,0	14.200 Micrograms per milliliter Standard Deviation 1.7450	13.348 Micrograms per milliliter Standard Deviation 4.4348	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Escalation Cohorts in Combination Treatment Period Week 12: Pre-dose, n=4,4,0	13.665 Micrograms per milliliter Standard Deviation 5.3833	11.958 Micrograms per milliliter Standard Deviation 2.4890	—	—

SECONDARY outcome

Timeframe: Week 5: Pre-dose, 1, 2, 3, 5-6, 6-7, 7-8 hours post-dose; Weeks 8 and 12: Pre-dose

Population: Pharmacokinetic Concentration Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for pharmacokinetic analysis of N-desmethyl enzalutamide.

Outcome measures

Outcome measures
Measure	Enzalutamide Only (run-in Period) n=8 Participants Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Expansion Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: Pre-dose, n=6	11.623 Micrograms per milliliter Standard Deviation 3.5552	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 1 hour, n=7	12.476 Micrograms per milliliter Standard Deviation 3.6642	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 2 hours, n=7	12.069 Micrograms per milliliter Standard Deviation 3.9492	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 3 hours, n=7	11.861 Micrograms per milliliter Standard Deviation 4.1782	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 5-6 hours, n=2	11.850 Micrograms per milliliter Standard Deviation 0.3536	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 6-7 hours, n=2	11.135 Micrograms per milliliter Standard Deviation 2.7789	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 5: 7-8 hours, n=2	11.050 Micrograms per milliliter Standard Deviation 2.8991	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 8: Pre-dose, n=8	14.450 Micrograms per milliliter Standard Deviation 4.7827	—	—	—
Plasma Concentration of N-desmethyl Enzalutamide in GSK2636771/Enzalutamide Expansion Cohort in Combination Treatment Period Week 12: Pre-dose, n=6	15.690 Micrograms per milliliter Standard Deviation 7.4271	—	—	—

Adverse Events

Enzalutamide Only (run-in Period)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK2636771 200mg/Enzalutamide 160mg Escalation

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK2636771 200mg/Enzalutamide 160mg Expansion

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK2636771 300mg/Enzalutamide 160mg Escalation

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

GSK2636771 400mg/Enzalutamide 160mg Escalation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enzalutamide Only (run-in Period) n=37 participants at risk Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the Enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Escalation n=11 participants at risk Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 participants at risk Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 participants at risk Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 participants at risk Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Acute kidney injury	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Cellulitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Cerebrovascular accident	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Injury, poisoning and procedural complications Fall	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Haematuria	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 4 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.

Other adverse events

Other adverse events
Measure	Enzalutamide Only (run-in Period) n=37 participants at risk Participants received enzalutamide monotherapy at the approved dose of 160 mg once daily orally for 14 days in run-in period to achieve near-steady-state levels of enzalutamide prior to initiating combination therapy with GSK2636771. Participants who completed the Enzalutamide run-in period continued with the combination therapy with GSK2636771.	GSK2636771 200mg/Enzalutamide 160mg Escalation n=11 participants at risk Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 200mg/Enzalutamide 160mg Expansion n=11 participants at risk Participants received GSK2636771 200 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose expansion cohort. Participants were enrolled in this cohort as an expansion of the dose escalation cohort (GSK2636771 200 mg/ enzalutamide 160 mg) to collect adequate data on safety, pharmacokinetics and pharmacodynamics.	GSK2636771 300mg/Enzalutamide 160mg Escalation n=12 participants at risk Participants received GSK2636771 300 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.	GSK2636771 400mg/Enzalutamide 160mg Escalation n=2 participants at risk Participants received GSK2636771 400 mg once daily orally in combination with enzalutamide 160 mg orally once daily in dose escalation cohort.
Gastrointestinal disorders Diarrhoea	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	54.5% 6/11 • Number of events 10 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	72.7% 8/11 • Number of events 19 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	58.3% 7/12 • Number of events 7 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	100.0% 2/2 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	36.4% 4/11 • Number of events 5 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	41.7% 5/12 • Number of events 5 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Fatigue	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	27.3% 3/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	36.4% 4/11 • Number of events 5 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	33.3% 4/12 • Number of events 5 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Blood and lymphatic system disorders Anaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	27.3% 3/11 • Number of events 4 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	41.7% 5/12 • Number of events 5 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	41.7% 5/12 • Number of events 7 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Nausea	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	36.4% 4/11 • Number of events 4 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	25.0% 3/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Vascular disorders Hypertension	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	27.3% 3/11 • Number of events 4 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	25.0% 3/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood creatinine increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Arthralgia	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	25.0% 3/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood alkaline phosphatase increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	27.3% 3/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Constipation	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	25.0% 3/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Dizziness	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Vascular disorders Hot flush	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	27.3% 3/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood bilirubin increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Blood and lymphatic system disorders Leukopenia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Lymphocyte count decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Oedema peripheral	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Vomiting	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Abdominal distension	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Aspartate aminotransferase increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood phosphorus increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Psychiatric disorders Confusional state	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Dysgeusia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Groin pain	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Haematuria	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Headache	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Vascular disorders Hypotension	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Blood and lymphatic system disorders Lymphopenia	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Malaise	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Blood and lymphatic system disorders Neutropenia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	18.2% 2/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Proteinuria	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Pyrexia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Taste disorder	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Weight decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	16.7% 2/12 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 3 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Psychiatric disorders Agitation	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Alanine aminotransferase increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Psychiatric disorders Anxiety	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood 25-hydroxycholecalciferol decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood lactate dehydrogenase increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Blood parathyroid hormone increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Reproductive system and breast disorders Breast pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Bronchitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Cauda equina syndrome	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Cellulitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Chills	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Conjunctivitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Defaecation urgency	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Psychiatric disorders Depression	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Dry mouth	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Dyspepsia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Dysuria	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Early satiety	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Eosinophil count increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Face oedema	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Injury, poisoning and procedural complications Fall	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Flatulence	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Gait disturbance	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Gout	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Haematocrit decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Haemoglobin decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Heart rate increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Hydronephrosis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Endocrine disorders Hyperparathyroidism	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Immune system disorders Hypersensitivity	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Inguinal hernia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Psychiatric disorders Insomnia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Mouth ulceration	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.4% 2/37 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Musculoskeletal and connective tissue disorders Myalgia intercostal	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Infections and infestations Nasopharyngitis	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Neutrophil count decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Pain of skin	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Cardiac disorders Palpitations	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Paraesthesia	2.7% 1/37 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Reproductive system and breast disorders Pelvic pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Reproductive system and breast disorders Perineal pain	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
General disorders Peripheral swelling	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Platelet count decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Pollakiuria	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Rash	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	50.0% 1/2 • Number of events 2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Red blood cell count decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Sciatica	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Cardiac disorders Sinus bradycardia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Nervous system disorders Syncope	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Cardiac disorders Tachycardia	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Thyroxine decreased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Gastrointestinal disorders Toothache	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	8.3% 1/12 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Renal and urinary disorders Urinary incontinence	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.
Investigations Urine potassium increased	0.00% 0/37 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/11 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	9.1% 1/11 • Number of events 1 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/12 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.	0.00% 0/2 • Up to Week 2 for run-in period and up to maximum of 675 days for combination treatment period All Treated Safety Population consisted of all participants who received at least one dose of GSK2636771 or Enzalutamide.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER