Trial Outcomes & Findings for Belatacept Therapy for the Failing Renal Allograft (NCT NCT01921218)

NCT ID: NCT01921218

Last Updated: 2021-01-26

Results Overview

The number of participants in each group with donor-specific antibody formation at 36 months following randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

Month 36

Results posted on

2021-01-26

Participant Flow

Participants were enrolled at Emory University Hospital and the Emory Clinic in Atlanta, Georgia. Enrollment began August 2013 and all follow up was complete by December 12, 2019.

Participant milestones

Participant milestones
Measure	Belatacept Treatment Group Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Study STARTED	6	7
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Belatacept Treatment Group Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Overall Study Death	2	1
Overall Study Withdrawal by Subject	0	2
Overall Study Kidney transplant	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belatacept Treatment Group n=6 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=7 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=6 Participants	7 Participants n=7 Participants	12 Participants n=13 Participants
Age, Categorical >=65 years	1 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=13 Participants
Age, Continuous	56.12 years STANDARD_DEVIATION 9.12 • n=6 Participants	45.69 years STANDARD_DEVIATION 14.99 • n=7 Participants	51.31 years STANDARD_DEVIATION 12.83 • n=13 Participants
Sex: Female, Male Female	2 Participants n=6 Participants	2 Participants n=7 Participants	4 Participants n=13 Participants
Sex: Female, Male Male	4 Participants n=6 Participants	5 Participants n=7 Participants	9 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 Participants n=6 Participants	7 Participants n=7 Participants	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: Month 36

The number of participants in each group with donor-specific antibody formation at 36 months following randomization.

Outcome measures

Outcome measures
Measure	Belatacept Treatment Group n=4 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=4 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Number of Participants With Donor-specific Antibody Formation	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: Participants requiring dialysis, either at the time of enrollment or initiating dialysis during the study, are not included in this analysis.

The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)\^(-0.999) x (Age)\^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)\^(-0.170) x (Alb)\^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years.

Outcome measures

Outcome measures
Measure	Belatacept Treatment Group n=4 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=2 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Glomerular Filtration Rate (GFR) Month 2	19.33 mL/min/1.73 m^2 Standard Deviation 4.93	10.5 mL/min/1.73 m^2 Standard Deviation 4.95
Glomerular Filtration Rate (GFR) Month 3	16.33 mL/min/1.73 m^2 Standard Deviation 1.53	16.5 mL/min/1.73 m^2 Standard Deviation 4.95
Glomerular Filtration Rate (GFR) Baseline	14.25 mL/min/1.73 m^2 Standard Deviation 7.80	14.5 mL/min/1.73 m^2 Standard Deviation 0.71
Glomerular Filtration Rate (GFR) Month 1	14.25 mL/min/1.73 m^2 Standard Deviation 8.06	11 mL/min/1.73 m^2 Standard Deviation 1.41
Glomerular Filtration Rate (GFR) Month 6	14.67 mL/min/1.73 m^2 Standard Deviation 1.15	14.5 mL/min/1.73 m^2 Standard Deviation 6.36
Glomerular Filtration Rate (GFR) Month 9	14.67 mL/min/1.73 m^2 Standard Deviation 3.06	13.5 mL/min/1.73 m^2 Standard Deviation 10.61
Glomerular Filtration Rate (GFR) Month 12	13.67 mL/min/1.73 m^2 Standard Deviation 2.89	20 mL/min/1.73 m^2 Standard Deviation 0
Glomerular Filtration Rate (GFR) Month 18	7 mL/min/1.73 m^2 Standard Deviation 0	—

SECONDARY outcome

Timeframe: Up to Year 2

Population: This analysis includes participants who initiated dialysis during the course of the study.

Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis.

Outcome measures

Outcome measures
Measure	Belatacept Treatment Group n=4 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=2 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Time to Initiation of Dialysis	11.75 months Standard Deviation 7.46	10.5 months Standard Deviation 2.12

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: This analysis includes participants remaining in the study at the indicated study visit.

The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies.

Outcome measures

Outcome measures
Measure	Belatacept Treatment Group n=6 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=7 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Baseline - Negative	6 Participants	5 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Baseline - Positive Class I	0 Participants	2 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Baseline - Positive Class II	0 Participants	0 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Baseline - Positive Class I and II	0 Participants	0 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 12 - Negative	4 Participants	2 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 12 - Positive Class I	1 Participants	4 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 12 - Positive Class II	0 Participants	3 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 12 - Positive Class I and II	0 Participants	3 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 24 - Negative	1 Participants	1 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 24 - Positive Class I	0 Participants	2 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 24 - Positive Class II	2 Participants	1 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 24 - Positive Class I and II	0 Participants	1 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 36 - Negative	1 Participants	1 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 36 - Positive Class I	0 Participants	2 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 36 - Positive Class II	2 Participants	1 Participants
Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies Month 36 - Positive Class I and II	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Month 36

The number of infections complications occurring among study participants is presented here.

Outcome measures

Outcome measures
Measure	Belatacept Treatment Group n=6 Participants Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=7 Participants Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Number of Infectious Complications	12 complications	18 complications

Adverse Events

Belatacept Treatment Group

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Control Group

Serious events: 5 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Idelberto R. Badell, MD

Emory University

Phone: 404-712-6562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Belatacept Treatment Group n=6 participants at risk Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=7 participants at risk Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Gastrointestinal disorders Gastrointestinal bleed	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Groin abscess	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Renal and urinary disorders Initiation of hemodialysis	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Blood and lymphatic system disorders Deep vein thrombosis and pulmonary embolism	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Product Issues Peritoneal dialysis catheter blockage or malfunction	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Vascular disorders Exacerbation of hypertension	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Chest pain	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Acute rejection	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	42.9% 3/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Respiratory, thoracic and mediastinal disorders Pericardial effusion	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	28.6% 2/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Cellulitis	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Septic shock	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Peritonitis with sepsis	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Hypertensive crisis with seizure	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Pneumonia related to H1N1 influenza culminating in death	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Pneumonia	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Infected permacath	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Bacteremia	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Vascular disorders Malfunctionig arteriovenous (AV) fistula with edema	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Renal and urinary disorders Increased creatinine	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Escherichia coli urinary tract infection	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Cardiac disorders Atrial flutter	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure with hypoxia	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Posterior Reversible Encephalopathy syndrome	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.

Other adverse events
Measure	Belatacept Treatment Group n=6 participants at risk Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Control Group n=7 participants at risk Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Respiratory, thoracic and mediastinal disorders Pulmonary edema, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Fatigue, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Fatigue, grade 2	50.0% 3/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Nausea, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	28.6% 2/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Gastrointestinal disorders Abdominal cramps, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Gastrointestinal disorders Diarrhea, grade 1	50.0% 3/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	57.1% 4/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Gastrointestinal disorders Diarrhea, grade 2	50.0% 3/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	28.6% 2/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Arthralgia, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Arthralgia, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Left leg cramps, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Metabolism and nutrition disorders Hypoglycemia, grade 2	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Bilateral feet cramps, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Peritonitis, grade 2	50.0% 3/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	57.1% 4/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Bilateral restless legs, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Forgetfulness, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Disc protrusion, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Facet joint hypertrophy, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Vascular disorders Hypertension, grade 3	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	14.3% 1/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Nervousness, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Lesion on upper palate, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Upper respiratory infection, grade 2	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Upper respiratory infection, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Tendonitis bilateral ankles, grade 1	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Cardiac disorders Chest pain, grade 3	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Cardiac disorders Chest pain, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	57.1% 4/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Skin and subcutaneous tissue disorders Pruritus, grade 2	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
General disorders Hypocalcemia, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Gastrointestinal disorders Abdominal pain, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Knee meniscus tear, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Osteoarthritis in knee, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Injury, poisoning and procedural complications Fractured toes due to motor vehicle accident, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Leg pain possibly due to sciatica, grade 2	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Reproductive system and breast disorders Benign right ovarian cysts, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Urinary tract infection with bacteremia, grade 3	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Cardiac disorders Atrial flutter, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma, grades 1 and 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Psychiatric disorders Anxiety, grade 1	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Infections and infestations Peritoneal dialysis site infection, grade 2	16.7% 1/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Respiratory, thoracic and mediastinal disorders Coughing and wheezing, grade 2	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Musculoskeletal and connective tissue disorders Exacerbation of gout, grades 2 and 3	33.3% 2/6 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.	0.00% 0/7 • Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38). Adverse events were graded by the physician investigator as follows: * Mild (Grade 1): awareness of event but easily tolerated * Moderate (Grade 2): discomfort enough to cause some interference with usual activity * Severe (Grade 3): inability to carry out usual activity * Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.