Trial Outcomes & Findings for Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (NCT NCT03056755)

Last Updated: 2026-01-13

Results Overview

Percentage of participants who were alive without disease progression at 6-month follow-up based on local investigator assessment per RECIST v1.1 in Cohort A, Cohort B and Cohort C. Participants who progressed, died, or discontinued study before 6 months were counted as a failure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

383 participants

Primary outcome timeframe

At 6 months

Results posted on

2026-01-13

Participant Flow

This study was conducted in 92 centers across 19 countries

Screening assessments occurred before 21 days of the start of treatment.

Participant milestones

Participant milestones
Measure	Cohort A: Pre-treated With CDK 4/6i + AI Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET Participants who received systemic chemotherapy or endocrine therapy (ET) (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase STARTED	127	126	126
Core Phase COMPLETED	1	0	10
Core Phase NOT COMPLETED	126	126	116
Extension Phase STARTED	1	0	10
Extension Phase COMPLETED	0	0	5
Extension Phase NOT COMPLETED	1	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Pre-treated With CDK 4/6i + AI Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET Participants who received systemic chemotherapy or endocrine therapy (ET) (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase Progressive disease	89	88	90
Core Phase Adverse Event	20	14	13
Core Phase Physician Decision	7	13	5
Core Phase Subject/guardian decision	5	8	4
Core Phase Death	3	2	4
Core Phase Protocol deviation	1	1	0
Core Phase Technical problems	1	0	0
Extension Phase Physician Decision	1	0	3
Extension Phase Adverse Event	0	0	1
Extension Phase Subject/guardian decision	0	0	1

Baseline Characteristics

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=127 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=126 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=126 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.	Total n=379 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=9 Participants	80 Participants n=6 Participants	83 Participants n=9 Participants	258 Participants n=205 Participants
Age, Categorical >=65 years	32 Participants n=9 Participants	46 Participants n=6 Participants	43 Participants n=9 Participants	121 Participants n=205 Participants
Sex: Female, Male Female	127 Participants n=9 Participants	126 Participants n=6 Participants	125 Participants n=9 Participants	378 Participants n=205 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	1 Participants n=205 Participants
Race/Ethnicity, Customized Caucasian	81 Participants n=9 Participants	85 Participants n=6 Participants	83 Participants n=9 Participants	249 Participants n=205 Participants
Race/Ethnicity, Customized Unknown	23 Participants n=9 Participants	24 Participants n=6 Participants	11 Participants n=9 Participants	58 Participants n=205 Participants
Race/Ethnicity, Customized Asian	12 Participants n=9 Participants	8 Participants n=6 Participants	28 Participants n=9 Participants	48 Participants n=205 Participants
Race/Ethnicity, Customized Black	6 Participants n=9 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants	8 Participants n=205 Participants
Race/Ethnicity, Customized Other	3 Participants n=9 Participants	7 Participants n=6 Participants	3 Participants n=9 Participants	13 Participants n=205 Participants
Race/Ethnicity, Customized Pacific islander	1 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	1 Participants n=205 Participants
Race/Ethnicity, Customized Missing	1 Participants n=9 Participants	1 Participants n=6 Participants	0 Participants n=9 Participants	2 Participants n=205 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months	53.8 Percentage of participants Interval 44.41 to 62.96	46.5 Percentage of participants Interval 37.1 to 56.07	53.0 Percentage of participants Interval 43.51 to 62.41

SECONDARY outcome

Timeframe: From date of first dose to date of first documented progression or death, up to 46 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

PFS is defined as the time from the date of first dose of study medication to the date of the first documented progression or death due to any cause occurring in the study. PFS was assessed based on local investigator's assessment according to RECIST v1.1. PFS was censored if no PFS event was observed before the cut-off date. The censoring date was the date of last adequate tumor assessment before the cut-off date. If a PFS event was observed after two or more missing or non-adequate tumor assessments, then PFS was censored at the last adequate tumor assessment. PFS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Progression Free Survival (PFS)	8.0 Months Interval 5.6 to 8.6	5.6 Months Interval 3.7 to 7.1	5.6 Months Interval 5.4 to 8.1

SECONDARY outcome

Timeframe: From date of first dose to date of first documented progression on next-line therapy or death, up to approximately 55 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

PFS2 is defined as time from the date of first dose of study medication to the date of first documented progression on next-line therapy or death from any cause. The first documented progression on next-line treatment is based on investigator assessment of progressive disease. PFS2 was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Progression Free Survival on Next Line Treatment (PFS2)	15.2 Months Interval 11.4 to 21.7	13.0 Months Interval 10.2 to 13.9	13.5 Months Interval 11.5 to 17.3

SECONDARY outcome

Timeframe: Up to 46 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1 in each cohort. CR: Disappearance of all non-nodal target lesions and all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm and all lymph nodes assigned as non-target lesions must be non-pathological in size (\<10 mm short axis) PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Overall Response Rate (ORR)	19.3 Percentage of participants Interval 12.7 to 27.6	17.5 Percentage of participants Interval 11.1 to 25.8	25.2 Percentage of participants Interval 17.6 to 34.2

SECONDARY outcome

Timeframe: Up to 46 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

CBR is defined as the percentage of participants with a BOR of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/ Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. CR: Disappearance of all non-nodal target lesions and all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm and all lymph nodes assigned as non-target lesions must be non-pathological in size (\<10 mm short axis) PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Clinical Benefit Rate (CBR)	46.2 Percentage of participants Interval 37.0 to 55.6	35.1 Percentage of participants Interval 26.4 to 44.6	38.3 Percentage of participants Interval 29.4 to 47.8

SECONDARY outcome

Timeframe: From date of first documented response to first documented progression or death, up to 33.3 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory. Additionally, subjects must have a confirmed CR or PR.

DOR is the time from the date of first documented response (confirmed CR or PR based on local investigator's assessment according to RECIST v1.1) to the date of first documented progression or death due to underlying cancer. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=23 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=20 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=29 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Duration of Response (DOR)	13.8 Months Interval 5.5 to 19.4	6.5 Months Interval 5.4 to 9.4	16.5 Months Interval 8.3 to 22.2

SECONDARY outcome

Timeframe: From date of first dose and up to approximately 55 months

Population: Subjects who have been assigned and received at least one dose of the study treatment. They must have a confirmed PI3KCA mutation from a Novartis designated laboratory.

OS is defined as the time of start of treatment to date of death or lost to follow-up. If a subject was not known to have died, then the OS data was censored at the date of the last known alive status for the patient.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=119 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant n=114 Participants Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET n=115 Participants Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Core Phase: Overall Survival (OS)	27.3 Months Interval 21.3 to 32.7	29.0 Months Interval 24.5 to 34.8	20.7 Months Interval 16.9 to 28.1

SECONDARY outcome

Timeframe: Day 1 of each extension cycle up to Cycle 29 (each cycle lasting 28 days); median duration of exposure to study treatment (alpelisib or fulvestrant) = 41 months

Population: All subjects in Extension Phase who received at least 1 dose of study treatment. All patients consisted of 1 patient from Cohort A and 10 patients from Cohort C pulled together.

Clinical Benefit Rate, as assessed by the Investigator during the Extension Phase, was defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), or an overall lesion response of Stable Disease (SD) or non-complete response/non-progressive disease that lasted at least 24 weeks, based on the local investigator's assessment according to Response Evaluation Criteria in Solid Tumors version 1.1.

Outcome measures

Outcome measures
Measure	Cohort A: Pre-treated With CDK 4/6i + AI n=11 Participants Participants who received any CDK 4/6i plus AI as immediate prior treatment will receive alpelisib + fulvestrant	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole	Cohort C: Pre-treated With Systemic Chemotherapy or ET Participants who received systemic chemotherapy or ET (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 1 Day 1	8 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 2 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 3 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 4 Day 1	6 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 5 Day 1	8 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 6 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 7 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 8 Day 1	6 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 9 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 10 Day 1	5 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 11 Day 1	4 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 12 Day 1	7 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 13 Day 1	4 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 14 Day 1	5 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 15 Day 1	4 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 16 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 17 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 18 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 19 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 20 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 21 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 22 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 23 Day 1	3 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 24 Day 1	2 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 25 Day 1	2 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 26 Day 1	2 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 27 Day 1	2 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 28 Day 1	2 Participants	—	—
Extension Phase: Percentage of Participants With Clinical Benefit as Assessed by the Investigator During the Extension Phase Extension Cycle 29 Day 1	1 Participants	—	—

Adverse Events

Cohort A: Pre-treated With CDK 4/6i + AI (Core Phase)

Serious events: 37 serious events

Other events: 126 other events

Deaths: 78 deaths

Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Core Phase)

Serious events: 48 serious events

Other events: 126 other events

Deaths: 76 deaths

Cohort C: Pre-treated With Systemic Chemotherapy or ET (Core Phase)

Serious events: 38 serious events

Other events: 124 other events

Deaths: 67 deaths

Cohort A: Pre-treated With CDK 4/6i + AI (Extension Phase)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Extension Phase)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort C: Pre-treated With Systemic Chemotherapy or ET (Extension Phase)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A: Pre-treated With CDK 4/6i + AI (Core Phase) n=127 participants at risk Cohort A: Pre-treated with CDK 4/6i + AI (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Core Phase) n=126 participants at risk Cohort B: Pre-treated with CDK 4/6i + fulvestrant (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort C: Pre-treated With Systemic Chemotherapy or ET (Core Phase) n=126 participants at risk Cohort C: Pre-treated with systemic chemotherapy or ET (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort A: Pre-treated With CDK 4/6i + AI (Extension Phase) n=1 participants at risk Cohort A: Pre-treated with CDK 4/6i + AI (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Extension Phase) Cohort B: Pre-treated with CDK 4/6i + fulvestrant (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)	Cohort C: Pre-treated With Systemic Chemotherapy or ET (Extension Phase) n=10 participants at risk Cohort C: Pre-treated with systemic chemotherapy or ET (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)
Blood and lymphatic system disorders Anaemia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Blood and lymphatic system disorders Febrile neutropenia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Acute myocardial infarction	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Pericardial effusion	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Supraventricular tachycardia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Vision blurred	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Abdominal pain	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Ascites	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Colitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Colitis ulcerative	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Diarrhoea	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Duodenal obstruction	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Dysphagia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Enteritis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Enterocolitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Erosive oesophagitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Haematemesis	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Intestinal perforation	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Mesenteric artery thrombosis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Nausea	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Subileus	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Vomiting	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Asthenia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Fatigue	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders General physical health deterioration	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Influenza like illness	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Performance status decreased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Pyrexia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Sudden death	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Hepatobiliary disorders Biliary obstruction	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Hepatobiliary disorders Hepatic failure	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Immune system disorders Anaphylactic reaction	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Immune system disorders Hypersensitivity	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Bacterial infection	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations COVID-19	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Device related infection	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Escherichia urinary tract infection	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Meningitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Pharyngitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Pneumonia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Pyelonephritis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Pyelonephritis acute	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Sepsis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Septic shock	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Urinary tract infection	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Wound infection	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Hip fracture	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Toxicity to various agents	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Alanine aminotransferase increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Aspartate aminotransferase increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood alkaline phosphatase increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood bilirubin increased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood creatine phosphokinase increased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Laboratory test abnormal	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Liver function test abnormal	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Dehydration	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hyperglycaemia	5.5% 7/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hyponatraemia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Arthralgia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Cerebral ischaemia	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Cerebrovascular accident	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Migraine with aura	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Monoparesis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Confusional state	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Psychotic disorder	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Suicidal ideation	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Acute kidney injury	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Hydronephrosis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Nephrolithiasis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Urinary retention	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Urinary tract obstruction	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Atelectasis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Hypoxia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Rash	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Vascular disorders Deep vein thrombosis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase

Other adverse events

Other adverse events
Measure	Cohort A: Pre-treated With CDK 4/6i + AI (Core Phase) n=127 participants at risk Cohort A: Pre-treated with CDK 4/6i + AI (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Core Phase) n=126 participants at risk Cohort B: Pre-treated with CDK 4/6i + fulvestrant (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort C: Pre-treated With Systemic Chemotherapy or ET (Core Phase) n=126 participants at risk Cohort C: Pre-treated with systemic chemotherapy or ET (Core Phase) - Events from the start to end of the Core Phase (up to 58 months)	Cohort A: Pre-treated With CDK 4/6i + AI (Extension Phase) n=1 participants at risk Cohort A: Pre-treated with CDK 4/6i + AI (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)	Cohort B: Pre-treated With CDK 4/6i + Fulvestrant (Extension Phase) Cohort B: Pre-treated with CDK 4/6i + fulvestrant (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)	Cohort C: Pre-treated With Systemic Chemotherapy or ET (Extension Phase) n=10 participants at risk Cohort C: Pre-treated with systemic chemotherapy or ET (Extension Phase) - Events from the start of the Core Phase through the end of the Extension Phase (up to 86 months)
Blood and lymphatic system disorders Anaemia	8.7% 11/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Blood and lymphatic system disorders Neutropenia	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Angina pectoris	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Atrial fibrillation	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Pericardial effusion	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Cardiac disorders Tachycardia	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Ear and labyrinth disorders Cerumen impaction	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Dry eye	5.5% 7/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Eye oedema	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Eye pruritus	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Eye swelling	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Lacrimation increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Eye disorders Vision blurred	7.9% 10/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Abdominal distension	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Abdominal pain	13.4% 17/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	16.7% 21/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.9% 10/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Abdominal pain upper	12.6% 16/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	13.5% 17/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Anal fissure	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Anal incontinence	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Anal inflammation	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Colitis ulcerative	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Constipation	9.4% 12/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	12.7% 16/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.9% 15/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Diarrhoea	64.6% 82/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	68.3% 86/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	54.0% 68/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	70.0% 7/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Dry mouth	8.7% 11/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.9% 10/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	8.7% 11/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Dyspepsia	15.0% 19/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.3% 13/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.3% 13/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Eructation	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Faeces soft	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Flatulence	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Gastrointestinal oedema	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Gastrointestinal pain	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Gingival pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Glossodynia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Hyperchlorhydria	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Lip dry	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Mouth ulceration	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Mucous stools	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Nausea	46.5% 59/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	54.0% 68/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.5% 51/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Oral pain	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Periodontal disease	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Proctalgia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Stomatitis	26.8% 34/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	34.1% 43/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.2% 38/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Gastrointestinal disorders Vomiting	24.4% 31/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	24.6% 31/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	24.6% 31/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Asthenia	18.9% 24/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	21.4% 27/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.9% 15/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Chest pain	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Facial pain	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Fatigue	30.7% 39/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.2% 38/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	34.9% 44/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	50.0% 5/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Influenza like illness	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Non-cardiac chest pain	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Oedema peripheral	7.9% 10/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	9.5% 12/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Pain	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Pyrexia	13.4% 17/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.1% 19/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.1% 19/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Thirst	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
General disorders Xerosis	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Immune system disorders Food allergy	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Immune system disorders Hypersensitivity	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Immune system disorders Seasonal allergy	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Bronchitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations COVID-19	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Conjunctivitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Cystitis	3.1% 4/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Erysipelas	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Herpes zoster	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Influenza	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Mastitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Nasal herpes	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Nasopharyngitis	7.1% 9/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Pneumonia	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Rhinitis	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Upper respiratory tract infection	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Infections and infestations Urinary tract infection	11.0% 14/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	8.7% 11/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.9% 15/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Contusion	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Skin graft failure	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Injury, poisoning and procedural complications Sunburn	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Alanine aminotransferase increased	10.2% 13/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.3% 13/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	14.3% 18/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Aspartate aminotransferase increased	13.4% 17/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	8.7% 11/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.9% 15/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood alkaline phosphatase increased	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood calcium increased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood cholesterol increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood creatine increased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood creatine phosphokinase increased	3.1% 4/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood creatinine increased	11.8% 15/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	9.5% 12/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood glucose increased	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood thyroid stimulating hormone increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Blood triglycerides increased	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Eosinophil count increased	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Gamma-glutamyltransferase increased	5.5% 7/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Glycosylated haemoglobin increased	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Lymphocyte count decreased	3.1% 4/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Investigations Weight decreased	14.2% 18/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.1% 19/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	18.3% 23/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Decreased appetite	29.1% 37/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	44.4% 56/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	33.3% 42/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.0% 4/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hyperglycaemia	59.8% 76/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	64.3% 81/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	67.5% 85/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	60.0% 6/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hypocalcaemia	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hypoglycaemia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hypokalaemia	7.9% 10/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	9.5% 12/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Hyponatraemia	7.1% 9/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Metabolism and nutrition disorders Polydipsia	3.1% 4/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 19/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	16.7% 21/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.1% 14/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Back pain	7.9% 10/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.1% 14/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	9.5% 12/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Bone pain	4.7% 6/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Muscle spasms	11.0% 14/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.9% 15/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.1% 14/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.3% 8/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Myalgia	7.9% 10/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.8% 6/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Neck pain	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Balance disorder	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Dizziness	6.3% 8/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Dysgeusia	14.2% 18/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	16.7% 21/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Headache	22.0% 28/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	19.8% 25/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	16.7% 21/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.0% 4/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Lethargy	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Memory impairment	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Nervous system disorders Muscle spasticity	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Depressed mood	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Depression	4.7% 6/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Psychiatric disorders Insomnia	4.7% 6/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Pollakiuria	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	3.2% 4/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Renal and urinary disorders Urinary incontinence	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Reproductive system and breast disorders Dyspareunia	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Reproductive system and breast disorders Vulvovaginal dryness	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Cough	11.0% 14/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.3% 13/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 19/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	11.1% 14/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.7% 6/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Alopecia	13.4% 17/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.9% 20/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.1% 19/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Dry skin	17.3% 22/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	19.0% 24/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	12.7% 16/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.0% 4/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Erythema	7.1% 9/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	5.6% 7/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Nail disorder	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Nail toxicity	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	6.3% 8/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Pruritus	15.7% 20/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.3% 13/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	23.0% 29/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	30.0% 3/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Rash	30.7% 39/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	31.0% 39/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.5% 51/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	40.0% 4/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Rash maculo-papular	12.6% 16/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	15.9% 20/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	7.1% 9/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Skin toxicity	0.79% 1/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Skin ulcer	2.4% 3/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Skin and subcutaneous tissue disorders Urticaria	3.9% 5/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	4.0% 5/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Vascular disorders Capillary fragility	0.00% 0/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.79% 1/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	0.00% 0/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Vascular disorders Hypertension	7.1% 9/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	8.7% 11/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	6.3% 8/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	20.0% 2/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase
Vascular disorders Lymphoedema	1.6% 2/127 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	1.6% 2/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	2.4% 3/126 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	100.0% 1/1 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	— 0/0 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase	10.0% 1/10 • Adverse Events (AEs) were collected from the first dose through post-treatment follow-up, for up to 86 months. Deaths were recorded from study start through post-treatment follow-up over the same period. AE data were summarized for core phase patients from start to end of the core phase (up to 58 months) and for extension phase patients from the start of the core phase through the end of the extension phase (up to 86 months). No patient from Cohort B entered Extension Phase

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER