Trial Outcomes & Findings for Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (NCT NCT02408861)

Last Updated: 2026-01-21

Results Overview

Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least \>= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

79 participants

Primary outcome timeframe

Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks

Results posted on

2026-01-21

Participant Flow

Enrollment started in October 2015 and ended June 2023 across 7 different cohorts, and 17 study sites.

Participants with histologically confirmed solid malignancy and HIV infection. Solid malignancy must be metastatic or unresectable and standard curative or palliative measures are nonexistent or no longer effective. Uncontrolled Kaposi sarcoma is permitted. Participants with relapsed refractory HIV-associated classical Hodgkin lymphoma (HIV-cHL) as a separate cohort.

Participant milestones

Participant milestones
Measure	Dose De-escalation Nivolumab 3mg/kg (Stratum 1) Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 1: Participants with CD4+ count \> 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 2 : Participants with CD4+ count between 100-200/mm3. Enrollment Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) Nivolumab 240mg and Ipilimumab 1 mg/kg (Dose level 2); Stratum 1: CD4 count \>200 per mm3; No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) Nivolumab 240 mg and Ipilimumab 1mg/kg (Dose level 2); Stratum 2: participants with lymphocyte T CD4+ count between 100-200/mm3; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg q2w and Ipilimumab 1 mg/kg q6w The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Overall Study STARTED	6	9	7	4	24	20	9
Overall Study Number of DLTs experienced within 6 weeks	0	0	1	0	0	0	0
Overall Study Patients receiving de-escalated dose of Nivolumab (1 mg/kg)	0	0	0	0	0	0	0
Overall Study COMPLETED	3	5	2	1	10	13	6
Overall Study NOT COMPLETED	3	4	5	3	14	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose De-escalation Nivolumab 3mg/kg (Stratum 1) Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 1: Participants with CD4+ count \> 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 2 : Participants with CD4+ count between 100-200/mm3. Enrollment Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) Nivolumab 240mg and Ipilimumab 1 mg/kg (Dose level 2); Stratum 1: CD4 count \>200 per mm3; No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) Nivolumab 240 mg and Ipilimumab 1mg/kg (Dose level 2); Stratum 2: participants with lymphocyte T CD4+ count between 100-200/mm3; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg q2w and Ipilimumab 1 mg/kg q6w The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Overall Study Death	0	3	1	2	4	1	0
Overall Study Lost to Follow-up	0	0	1	1	4	2	1
Overall Study Disease Progression	0	0	1	0	3	1	1
Overall Study Adverse Event	1	0	1	0	2	0	0
Overall Study Physician Decision	1	1	1	0	0	1	0
Overall Study Protocol Violation	1	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	1	1	0
Overall Study Other Treatment	0	0	0	0	0	1	1

Baseline Characteristics

Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=79 Participants Total of all reporting groups	Dose De-escalation Nivolumab 3mg/kg (Stratum 1) n=6 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) n=7 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3. Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=24 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg q2w and Ipilimumab 1 mg/kg q6w n=20 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=9 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Age, Continuous	51.9 years STANDARD_DEVIATION 12.3 • n=4 Participants	55.0 years STANDARD_DEVIATION 6.2 • n=37 Participants	59.4 years STANDARD_DEVIATION 4.3 • n=44 Participants	57.0 years STANDARD_DEVIATION 6.6 • n=40 Participants	45.8 years STANDARD_DEVIATION 16.8 • n=121 Participants	49.6 years STANDARD_DEVIATION 11.2 • n=24 Participants	52.6 years STANDARD_DEVIATION 17.0 • n=6 Participants	46.1 years STANDARD_DEVIATION 9.8 • n=33 Participants
Sex: Female, Male Female	7 Participants n=4 Participants	1 Participants n=37 Participants	0 Participants n=44 Participants	2 Participants n=40 Participants	0 Participants n=121 Participants	3 Participants n=24 Participants	1 Participants n=6 Participants	0 Participants n=33 Participants
Sex: Female, Male Male	72 Participants n=4 Participants	5 Participants n=37 Participants	9 Participants n=44 Participants	5 Participants n=40 Participants	4 Participants n=121 Participants	21 Participants n=24 Participants	19 Participants n=6 Participants	9 Participants n=33 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=4 Participants	0 Participants n=37 Participants	1 Participants n=44 Participants	2 Participants n=40 Participants	0 Participants n=121 Participants	3 Participants n=24 Participants	4 Participants n=6 Participants	3 Participants n=33 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=4 Participants	6 Participants n=37 Participants	8 Participants n=44 Participants	5 Participants n=40 Participants	4 Participants n=121 Participants	19 Participants n=24 Participants	15 Participants n=6 Participants	6 Participants n=33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	2 Participants n=24 Participants	1 Participants n=6 Participants	0 Participants n=33 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=4 Participants	1 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Black or African American	23 Participants n=4 Participants	1 Participants n=37 Participants	3 Participants n=44 Participants	1 Participants n=40 Participants	4 Participants n=121 Participants	7 Participants n=24 Participants	6 Participants n=6 Participants	1 Participants n=33 Participants
Race (NIH/OMB) White	50 Participants n=4 Participants	4 Participants n=37 Participants	6 Participants n=44 Participants	4 Participants n=40 Participants	0 Participants n=121 Participants	16 Participants n=24 Participants	12 Participants n=6 Participants	8 Participants n=33 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	2 Participants n=40 Participants	0 Participants n=121 Participants	1 Participants n=24 Participants	2 Participants n=6 Participants	0 Participants n=33 Participants
ECOG Grade of Performance Status ECOG Grade 0	33 Participants n=4 Participants	3 Participants n=37 Participants	2 Participants n=44 Participants	2 Participants n=40 Participants	1 Participants n=121 Participants	11 Participants n=24 Participants	10 Participants n=6 Participants	4 Participants n=33 Participants
ECOG Grade of Performance Status ECOG Grade 1	46 Participants n=4 Participants	3 Participants n=37 Participants	7 Participants n=44 Participants	5 Participants n=40 Participants	3 Participants n=121 Participants	13 Participants n=24 Participants	10 Participants n=6 Participants	5 Participants n=33 Participants
Count by cancer type Kaposi's Sarcoma	33 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	2 Participants n=40 Participants	1 Participants n=121 Participants	15 Participants n=24 Participants	15 Participants n=6 Participants	0 Participants n=33 Participants
Count by cancer type Hodgkin's lymphoma	9 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	9 Participants n=33 Participants
Count by cancer type Anal Cancer	9 Participants n=4 Participants	0 Participants n=37 Participants	5 Participants n=44 Participants	0 Participants n=40 Participants	1 Participants n=121 Participants	1 Participants n=24 Participants	2 Participants n=6 Participants	0 Participants n=33 Participants
Count by cancer type Lung cancer	6 Participants n=4 Participants	0 Participants n=37 Participants	2 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	2 Participants n=24 Participants	2 Participants n=6 Participants	0 Participants n=33 Participants
Count by cancer type Colon cancer	4 Participants n=4 Participants	0 Participants n=37 Participants	0 Participants n=44 Participants	3 Participants n=40 Participants	0 Participants n=121 Participants	1 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Count by cancer type Head and Neck Cancer	3 Participants n=4 Participants	2 Participants n=37 Participants	1 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=24 Participants	0 Participants n=6 Participants	0 Participants n=33 Participants
Count by cancer type Other cancer types	15 Participants n=4 Participants	4 Participants n=37 Participants	1 Participants n=44 Participants	2 Participants n=40 Participants	2 Participants n=121 Participants	5 Participants n=24 Participants	1 Participants n=6 Participants	0 Participants n=33 Participants

PRIMARY outcome

Timeframe: Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks

Population: Safety evaluable population treated with at least a single dose of Nivolumab.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=6 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Maximum Tolerated Dose of Nivolumab	3 mg/kg	3 mg/kg	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 weeks from the first dose of Nivolumab

Population: Patients evaluated for safety during 6 weeks from the first dose

Incidence of DLTs during the safety evaluation period of 6 weeks at a given dose from the first dose of treatment.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=6 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=7 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Participants will be followed for 16 weeks or 112 days after removal from study treatment, or until death, whichever occurs first.

Number of adverse events that are either possibly, probably or definitely attributed to study intervention. In case an adverse event as per the CTCAE v5.0 occurs within a same patient, an instance with the highest severity of the adverse event is counted. Separate event-instances are reported otherwise.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=6 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=7 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=24 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=20 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=9 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Incidence of Adverse Events According to NCI CTCAE v5.0 Adverse Events	27 Events	29 Events	26 Events	8 Events	54 Events	72 Events	29 Events
Incidence of Adverse Events According to NCI CTCAE v5.0 Serious Adverse Events	3 Events	5 Events	2 Events	1 Events	5 Events	3 Events	2 Events

SECONDARY outcome

Timeframe: Up to 3 years

Population: Patients exposed to at least a single dose of study drug(s)

The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma \[cHL\]) and their corresponding 95% confidence intervals (calculated using exact binomial) will be reported separately for solid tumor and cHL according to treatment (combination therapy and single agent) using designated response criteria. Descriptive statistics will also be compiled for duration of response.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=5 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=8 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=7 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=23 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=20 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=9 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Objective Response Rate Complete Response	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Objective Response Rate Partial Response	2 Participants	0 Participants	0 Participants	1 Participants	7 Participants	4 Participants	5 Participants
Objective Response Rate Objective Response (complete or partial response)	2 Participants	0 Participants	0 Participants	2 Participants	7 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: end of 46 cycles of treatment+ 6 weeks

Population: Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit

Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on immune function (CD4 and CD8 cells). Changes in CD4+ T-cell counts, CD8+ T-cell from baseline to end of 46 cycles of treatment+ 6 weeks visit were evaluated by Wilcoxon signed-rank test for paired data.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=3 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=7 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=3 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=3 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=11 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=11 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=7 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks CD4+ T-cell counts at baseline	322 cells/mm3 Interval 283.0 to 400.0	150 cells/mm3 Interval 115.0 to 152.0	563 cells/mm3 Interval 254.0 to 933.0	201 cells/mm3 Interval 106.0 to 203.0	412 cells/mm3 Interval 295.0 to 487.0	433 cells/mm3 Interval 232.0 to 594.0	319 cells/mm3 Interval 287.0 to 588.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks CD4+ T-cell counts at end of 46 cycles of treatment+ 6 weeks	323 cells/mm3 Interval 240.0 to 565.0	125 cells/mm3 Interval 87.0 to 138.0	681 cells/mm3 Interval 308.0 to 899.0	177.5 cells/mm3 Interval 122.0 to 233.0	296 cells/mm3 Interval 203.0 to 427.0	422 cells/mm3 Interval 308.0 to 846.0	547 cells/mm3 Interval 237.0 to 661.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks CD8+ T-cell counts at baseline	784 cells/mm3 Interval 778.0 to 791.0	380 cells/mm3 Interval 275.0 to 420.0	758 cells/mm3 Interval 657.0 to 789.0	311 cells/mm3 Interval 288.0 to 561.0	947 cells/mm3 Interval 348.0 to 1183.0	703 cells/mm3 Interval 514.0 to 1073.0	638 cells/mm3 Interval 302.0 to 1309.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks CD8+ T-cell counts at end of 46 cycles of treatment+ 6 weeks	516 cells/mm3 Interval 476.0 to 1021.0	192 cells/mm3 Interval 161.0 to 260.0	737 cells/mm3 Interval 632.0 to 909.0	433 cells/mm3 Interval 198.0 to 668.0	584 cells/mm3 Interval 275.0 to 874.0	603 cells/mm3 Interval 551.0 to 1195.0	760 cells/mm3 Interval 424.0 to 1048.0

SECONDARY outcome

Timeframe: end of 46 cycles of treatment+ 16 weeks

Population: Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit

Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on immune function (CD4 and CD8 cells). Changes in CD4+ T-cell counts, CD8+ T-cell from baseline to end of 46 cycles of treatment+ 16 weeks visit were evaluated by Wilcoxon signed-rank test for paired data.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=3 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=3 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=3 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=1 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=11 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=8 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=5 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks CD8+ T-cell counts at baseline	791 cells/mm3 Interval 784.0 to 1446.0	441 cells/mm3 Interval 420.0 to 462.0	758 cells/mm3 Interval 657.0 to 789.0	561 cells/mm3 Interval 561.0 to 561.0	1001.5 cells/mm3 Interval 828.0 to 1183.0	545 cells/mm3 Interval 473.0 to 707.0	1004 cells/mm3 Interval 638.0 to 1309.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks CD4+ T-cell counts at baseline	400 cells/mm3 Interval 284.0 to 443.0	152 cells/mm3 Interval 151.0 to 193.0	563 cells/mm3 Interval 254.0 to 933.0	106 cells/mm3 Interval 106.0 to 106.0	379 cells/mm3 Interval 295.0 to 720.0	391.5 cells/mm3 Interval 222.0 to 604.5	451 cells/mm3 Interval 319.0 to 588.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks CD4+ T-cell counts at end of 46 cycles of treatment+ 16 weeks	270 cells/mm3 Interval 267.0 to 402.0	127 cells/mm3 Interval 60.0 to 199.0	692 cells/mm3 Interval 292.0 to 1122.0	197 cells/mm3 Interval 197.0 to 197.0	295 cells/mm3 Interval 242.0 to 707.0	441 cells/mm3 Interval 336.5 to 881.0	569 cells/mm3 Interval 400.0 to 577.0
Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks CD8+ T-cell counts at end of 46 cycles of treatment+ 16 weeks	801 cells/mm3 Interval 499.0 to 1062.0	147 cells/mm3 Interval 139.0 to 251.0	956 cells/mm3 Interval 754.0 to 1019.0	616 cells/mm3 Interval 616.0 to 616.0	910 cells/mm3 Interval 293.0 to 1071.0	724.5 cells/mm3 Interval 563.0 to 879.5	1042 cells/mm3 Interval 679.0 to 1200.0

SECONDARY outcome

Timeframe: end of 46 cycles of treatment+ 6 weeks

Population: Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit

Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on HIV viral load. Changes in HIV viral load from baseline to end of 46 cycles of treatment+ 6 weeks visit were evaluated by Wilcoxon signed-rank test for paired data.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=3 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=7 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=3 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=2 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=12 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=12 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=7 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks HIV viral load at baseline	20 cells/mm3 Interval 10.0 to 20.0	10 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 20.0	19.5 cells/mm3 Interval 10.0 to 29.0	15 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 47.0
HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks HIV viral load at end of 46 cycles of treatment+ 6 weeks	20 cells/mm3 Interval 10.0 to 20.0	10 cells/mm3 Interval 10.0 to 10.0	20 cells/mm3 Interval 20.0 to 36.0	40.5 cells/mm3 Interval 40.0 to 41.0	15 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 40.0

SECONDARY outcome

Timeframe: end of 46 cycles of treatment+16 weeks

Population: Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit

Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on HIV viral load. Changes in HIV viral load from baseline to end of 46 cycles of treatment+ 16 weeks visit were evaluated by Wilcoxon signed-rank test for paired data.

Outcome measures

Outcome measures
Measure	Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) n=3 Participants Stratum 1 will enroll participants with CD4+ count above 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=3 Participants Stratum 2 will enroll participants with CD4+ count between 100-200/mm3. Enrollment in Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) n=3 Participants Stratum 1 dosing will start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=1 Participants Stratum 2 will enroll participants with lymphocyte T CD4+ count between 100-200/mm3 Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=9 Participants Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=8 Participants The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=5 Participants Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks HIV viral load at baseline	20 cells/mm3 Interval 10.0 to 20.0	10 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 20.0	10 cells/mm3 Interval 10.0 to 10.0	10 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 15.0 to 20.0	36 cells/mm3 Interval 20.0 to 47.0
HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks HIV viral load at end of 46 cycles of treatment+ 16 weeks	20 cells/mm3 Interval 10.0 to 20.0	10 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 10.0 to 60.0	10 cells/mm3 Interval 10.0 to 10.0	20 cells/mm3 Interval 10.0 to 20.0	20 cells/mm3 Interval 15.0 to 20.0	20 cells/mm3 Interval 20.0 to 30.0

Adverse Events

Dose De-escalation Nivolumab 3mg/kg (Stratum 1)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Dose De-escalation Nivolumab 3 mg/kg (Stratum 2)

Serious events: 6 serious events

Other events: 8 other events

Deaths: 3 deaths

Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Dose Expansion Nivolumab 240 mg q2w in Solid Tumors

Serious events: 9 serious events

Other events: 22 other events

Deaths: 5 deaths

Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg

Serious events: 6 serious events

Other events: 20 other events

Deaths: 1 deaths

Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose De-escalation Nivolumab 3mg/kg (Stratum 1) n=6 participants at risk Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 1: Participants with CD4+ count \> 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 participants at risk Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 2 : Participants with CD4+ count between 100-200/mm3. Enrollment Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) n=7 participants at risk Nivolumab 240mg and Ipilimumab 1 mg/kg (Dose level 2); Stratum 1: CD4 count \>200 per mm3; No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 participants at risk Nivolumab 240 mg and Ipilimumab 1mg/kg (Dose level 2); Stratum 2: participants with lymphocyte T CD4+ count between 100-200/mm3; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=24 participants at risk Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=20 participants at risk The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=9 participants at risk Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
CARDIAC DISORDERS CARDIAC ARREST	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
CARDIAC DISORDERS CARDIAC DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
CARDIAC DISORDERS PERICARDIAL TAMPONADE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
ENDOCRINE DISORDERS ADRENAL INSUFFICIENCY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
ENDOCRINE DISORDERS HYPOTHYROIDISM	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ASCITES	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS COLITIS	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS CONSTIPATION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS DIARRHEA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ORAL HEMORRHAGE	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS SMALL INTESTINAL OBSTRUCTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS DEATH NOS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS DISEASE PROGRESSION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 2/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
HEPATOBILIARY DISORDERS HEPATIC FAILURE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS LUNG INFECTION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS RASH PUSTULAR	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS SEPSIS	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS SKIN INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS UPPER RESPIRATORY INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FRACTURE	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCEMIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPONATREMIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS ENCEPHALOPATHY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS ACUTE KIDNEY INJURY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 2/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS ASPIRATION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS ATELECTASIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY FAILURE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	5.0% 1/20 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
VASCULAR DISORDERS HYPOTENSION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	4.2% 1/24 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.

Other adverse events

Other adverse events
Measure	Dose De-escalation Nivolumab 3mg/kg (Stratum 1) n=6 participants at risk Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 1: Participants with CD4+ count \> 200/mm3. Start with a full dose of nivolumab 3 mg/kg (dose level 1) and one dose de-escalation is allowed; after evaluating dosing for single agent nivolumab then participants will be treated with 240 mg of nivolumab. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) n=9 participants at risk Nivolumab 3 mg/kg body weight (Dose level 1) Stratum 2 : Participants with CD4+ count between 100-200/mm3. Enrollment Stratum 2 will begin after Stratum 1 has completed. Stratum 2 dosing will begin at the single-agent therapy MTD for Stratum 1 (dose level 1 or -1). Stratum 2 will not be allowed to escalate beyond the MTD for Stratum 1. Only 1 dose de-escalation will be allowed.	Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) n=7 participants at risk Nivolumab 240mg and Ipilimumab 1 mg/kg (Dose level 2); Stratum 1: CD4 count \>200 per mm3; No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) n=4 participants at risk Nivolumab 240 mg and Ipilimumab 1mg/kg (Dose level 2); Stratum 2: participants with lymphocyte T CD4+ count between 100-200/mm3; Participants will be treated with 240 mg of nivolumab and 1 mg/kg of ipilimumab will be added to evaluate combination therapy (dose level 2) with one dose de- escalation allowed. No intra-participant dose escalations will be allowed. The safety evaluation period is 6 weeks at a given dose level.	Dose Expansion Nivolumab 240 mg q2w in Solid Tumors n=24 participants at risk Participants with incurable solid tumors will be treated at single agent nivolumab 240 mg every 2 weeks. Only those histologies that are not known to respond to single agent nivolumab will be excluded (i.e., pancreas, prostate, MSS colorectal cancer, unless results from another clinical trial showing non-response in another tumor type become available in the future). Up to 24 participants will be enrolled.	Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg n=20 participants at risk The combination therapy MTD will be studied in a dose expansion cohort (up to 12 participants) limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer.	Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma n=9 participants at risk Single agent Nivolumab therapy will be administered in participants with classical Hodgkin's Lymphoma with a fixed dose of 240 mg q 2 week.
BLOOD AND LYMPHATIC SYSTEM DISORDERS ANEMIA	16.7% 1/6 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 8 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
BLOOD AND LYMPHATIC SYSTEM DISORDERS BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
CARDIAC DISORDERS SINUS BRADYCARDIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EAR AND LABYRINTH DISORDERS EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EAR AND LABYRINTH DISORDERS EAR PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
ENDOCRINE DISORDERS HYPOTHYROIDISM	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EYE DISORDERS BLURRED VISION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EYE DISORDERS DRY EYE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EYE DISORDERS EYE DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EYE DISORDERS RETINAL VASCULAR DISORDER	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
EYE DISORDERS UVEITIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	28.6% 2/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ANAL HEMORRHAGE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ANAL PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS BLOATING	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS COLITIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS CONSTIPATION	33.3% 2/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	28.6% 2/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS DENTAL CARIES	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS DIARRHEA	66.7% 4/6 • Number of events 6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	57.1% 4/7 • Number of events 8 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	35.0% 7/20 • Number of events 12 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS DRY MOUTH	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS DYSPEPSIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS FLATULENCE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS GINGIVAL PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS MUCOSITIS ORAL	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS NAUSEA	33.3% 2/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	57.1% 4/7 • Number of events 8 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 2/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	16.7% 4/24 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 5/20 • Number of events 16 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	44.4% 4/9 • Number of events 6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ORAL DYSESTHESIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ORAL HEMORRHAGE	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS ORAL PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS RECTAL FISTULA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS TOOTHACHE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GASTROINTESTINAL DISORDERS VOMITING	33.3% 2/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	28.6% 2/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 2/4 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 12 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHILLS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS EDEMA FACE	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS EDEMA LIMBS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 5/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FATIGUE	50.0% 3/6 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	44.4% 4/9 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	42.9% 3/7 • Number of events 6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	75.0% 3/4 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 8/24 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 10/20 • Number of events 17 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FEVER	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FLU LIKE SYMPTOMS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GAIT DISTURBANCE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS MALAISE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	28.6% 2/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	16.7% 4/24 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	30.0% 6/20 • Number of events 12 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS ANORECTAL INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS BLADDER INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS BRONCHIAL INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS LUNG INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS PAPULOPUSTULAR RASH	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS SINUSITIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS SKIN INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS THRUSH	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS TOOTH INFECTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INFECTIONS AND INFESTATIONS UPPER RESPIRATORY INFECTION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS BRUISING	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FALL	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS INFUSION RELATED REACTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	16.7% 1/6 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS ALKALINE PHOSPHATASE INCREASED	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	16.7% 1/6 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS CD4 LYMPHOCYTES DECREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS CREATININE INCREASED	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS INVESTIGATIONS - OTHER, SPECIFY	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS LIPASE INCREASED	33.3% 2/6 • Number of events 10 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS LYMPHOCYTE COUNT DECREASED	33.3% 2/6 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS NEUTROPHIL COUNT DECREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS PLATELET COUNT DECREASED	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS SERUM AMYLASE INCREASED	16.7% 1/6 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 11 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS THYROID STIMULATING HORMONE INCREASED	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS WEIGHT GAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS WEIGHT LOSS	16.7% 1/6 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
INVESTIGATIONS WHITE BLOOD CELL DECREASED	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	55.6% 5/9 • Number of events 11 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS ANOREXIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	28.6% 2/7 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCEMIA	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPERKALEMIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPERNATREMIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPOALBUMINEMIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	16.7% 4/24 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPOCALCEMIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPOGLYCEMIA	33.3% 2/6 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPONATREMIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS HYPOPHOSPHATEMIA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
METABOLISM AND NUTRITION DISORDERS METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.8% 5/24 • Number of events 10 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRITIS	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BACK PAIN	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	42.9% 3/7 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS FLANK PAIN	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS GENERALIZED MUSCLE WEAKNESS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCLE CRAMP	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MYALGIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS NECK PAIN	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) TUMOR PAIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS DIZZINESS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS DYSGEUSIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS HEADACHE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	12.5% 3/24 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	30.0% 6/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS LETHARGY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS PARESTHESIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS PERIPHERAL SENSORY NEUROPATHY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS PRESYNCOPE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS SYNCOPE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
NERVOUS SYSTEM DISORDERS VASOVAGAL REACTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
PSYCHIATRIC DISORDERS ANXIETY	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
PSYCHIATRIC DISORDERS INSOMNIA	33.3% 2/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
PSYCHIATRIC DISORDERS PSYCHIATRIC DISORDERS - OTHER, SPECIFY	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS CHRONIC KIDNEY DISEASE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS DYSURIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS RENAL AND URINARY DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS URINARY FREQUENCY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS URINARY RETENTION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RENAL AND URINARY DISORDERS URINARY URGENCY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENITAL EDEMA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS VAGINAL HEMORRHAGE	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS BRONCHIAL OBSTRUCTION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS COUGH	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	75.0% 3/4 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	29.2% 7/24 • Number of events 8 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	30.0% 6/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	44.4% 4/9 • Number of events 8 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	35.0% 7/20 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS EPISTAXIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 5 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HOARSENESS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS NASAL CONGESTION	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMONITIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS POSTNASAL DRIP	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PRODUCTIVE COUGH	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	15.0% 3/20 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RHINORRHEA	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SNEEZING	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SORE THROAT	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ALOPECIA	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS DRY SKIN	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	10.0% 2/20 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS HYPERHIDROSIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS HYPERTRICHOSIS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	8.3% 2/24 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	30.0% 6/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH ACNEIFORM	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH MACULO-PAPULAR	16.7% 1/6 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	22.2% 2/9 • Number of events 3 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.8% 5/24 • Number of events 9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	20.0% 4/20 • Number of events 7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	33.3% 3/9 • Number of events 4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	14.3% 1/7 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
SURGICAL AND MEDICAL PROCEDURES SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
VASCULAR DISORDERS HOT FLASHES	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
VASCULAR DISORDERS HYPERTENSION	16.7% 1/6 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	50.0% 2/4 • Number of events 2 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 6/24 • Number of events 15 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	40.0% 8/20 • Number of events 17 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
VASCULAR DISORDERS HYPOTENSION	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	25.0% 1/4 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.
VASCULAR DISORDERS THROMBOEMBOLIC EVENT	0.00% 0/6 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/9 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/7 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/4 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/24 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	0.00% 0/20 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.	11.1% 1/9 • Number of events 1 • Participants were followed for 16 weeks or 112 days (based on 5 half lives) after removal from study treatment, or until death, whichever occured first. Participants removed from study for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event. All adverse events, irrespective of their attribution have been included.

Additional Information

Dr Himanshu Joshi MBBS MPH PhD

Icahn School of Medicine at Mount Sinai

Phone: 2126599635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60