Trial Outcomes & Findings for Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04) (NCT NCT01643928)

Results Overview

Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

185 participants

Primary outcome timeframe

Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.

Results posted on

2019-01-29

Participant Flow

This was an extension study for participants with active rheumatoid arthritis who had participated for at least 16 weeks in a prior rituximab-Pfizer protocol (B3281001) and had not received intervening treatment with investigational agents or other biologics (including Rituxan and MabThera).

Participants given PF-05280586 in Study B3281001 received PF-05280586. Participants given licensed product in Study B3281001 received the same licensed product or PF-05280586 in Course 1. All participants received PF-05280586 in later courses. 185 participants were randomized to Study B3281004, 183 participants received study treatment.

Participant milestones

Participant milestones
Measure	PF-05280586/PF-05280586/PF-05280586 This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.	Rituximab-EU/PF-05280586/PF-05280586 This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (EU) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	Rituximab-US/PF-05280586/PF-05280586 This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (US) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Overall Study STARTED	58	32	33	30	30
Overall Study COMPLETED	48	30	30	27	28
Overall Study NOT COMPLETED	10	2	3	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-05280586/PF-05280586/PF-05280586 This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.	Rituximab-EU/PF-05280586/PF-05280586 This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (EU) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	Rituximab-US/PF-05280586/PF-05280586 This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (US) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Overall Study Lost to Follow-up	1	0	2	0	0
Overall Study Withdrawal by Subject	2	0	0	1	0
Overall Study Pregnancy	0	0	0	1	0
Overall Study Other	5	1	1	0	0
Overall Study Adverse Event	2	1	0	1	2

Baseline Characteristics

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-05280586/PF-05280586/PF-05280586 n=58 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.	Rituximab-EU/PF-05280586/PF-05280586 n=32 Participants This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (EU) n=33 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	Rituximab-US/PF-05280586/PF-05280586 n=30 Participants This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (US) n=30 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	Total n=183 Participants Total of all reporting groups
Age, Continuous	55.3 Years STANDARD_DEVIATION 12.01 • n=5 Participants	56.0 Years STANDARD_DEVIATION 11.88 • n=7 Participants	56.7 Years STANDARD_DEVIATION 9.35 • n=5 Participants	52.6 Years STANDARD_DEVIATION 13.73 • n=4 Participants	55.8 Years STANDARD_DEVIATION 10.35 • n=21 Participants	55.3 Years STANDARD_DEVIATION 11.55 • n=10 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	29 Participants n=7 Participants	23 Participants n=5 Participants	20 Participants n=4 Participants	25 Participants n=21 Participants	147 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	36 Participants n=10 Participants

PRIMARY outcome

Timeframe: Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.

Population: Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.

Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.

Outcome measures

Outcome measures
Measure	PF-05280586/PF-05280586/PF-05280586 n=58 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.	Rituximab-EU/PF-05280586/PF-05280586 n=32 Participants This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (EU) n=33 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	Rituximab-EU Total n=65 Participants Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.	Rituximab-US/PF-05280586/PF-05280586 n=30 Participants This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (US) n=30 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	Rituximab-US Total n=60 Participants Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay Total (C1) +ve	3.5 Percentage of Participants	0.0 Percentage of Participants	15.2 Percentage of Participants	7.8 Percentage of Participants	13.3 Percentage of Participants	6.7 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay Total (C3) +ve	2.1 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay C1 to C3 +ve	8.6 Percentage of Participants	3.1 Percentage of Participants	15.2 Percentage of Participants	9.2 Percentage of Participants	13.3 Percentage of Participants	6.7 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay Total (C2) +ve	5.7 Percentage of Participants	3.3 Percentage of Participants	0.0 Percentage of Participants	1.6 Percentage of Participants	0.0 Percentage of Participants	6.9 Percentage of Participants	3.4 Percentage of Participants

PRIMARY outcome

Timeframe: Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.

Population: mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.

Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.

Outcome measures

Outcome measures
Measure	PF-05280586/PF-05280586/PF-05280586 n=58 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.	Rituximab-EU/PF-05280586/PF-05280586 n=32 Participants This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (EU) n=33 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.	Rituximab-EU Total n=65 Participants Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.	Rituximab-US/PF-05280586/PF-05280586 n=30 Participants This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	PF-05280586/PF-05280586/PF-05280586 (US) n=30 Participants This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.	Rituximab-US Total n=60 Participants Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay Total (C1) +ve	3.5 Percentage of Participants	3.2 Percentage of Participants	15.2 Percentage of Participants	9.4 Percentage of Participants	10.0 Percentage of Participants	10.0 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay Total (C2) +ve	5.7 Percentage of Participants	6.7 Percentage of Participants	3.2 Percentage of Participants	4.9 Percentage of Participants	3.4 Percentage of Participants	13.8 Percentage of Participants	8.6 Percentage of Participants
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay Total (C3) +ve	2.1 Percentage of Participants	0.0 Percentage of Participants	3.3 Percentage of Participants	1.7 Percentage of Participants	0.0 Percentage of Participants	3.4 Percentage of Participants	1.8 Percentage of Participants
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay C1 to C3 +ve	8.6 Percentage of Participants	6.3 Percentage of Participants	18.2 Percentage of Participants	12.3 Percentage of Participants	13.3 Percentage of Participants	13.3 Percentage of Participants	13.3 Percentage of Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-05280586: by the End of Course 1 n=58 participants at risk This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU: by the End of Course 1 n=32 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 1 n=33 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US: by the End of Course 1 n=30 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 1 n=30 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586: by the End of Course 2 n=54 participants at risk This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU/PF-05280586: by the End of Course 2 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 2 n=31 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US/PF-05280586: by the End of Course 2 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 2 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586: by the End of Course 3 n=48 participants at risk This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 3 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3 n=27 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 3 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Blood and lymphatic system disorders Anaemia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Cardiac disorders Pericarditis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Diaphragmatic Hernia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Pancreatitis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Arthritis Infective	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Bronchitis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Gastroenteritis Viral	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Pneumonia	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.5% 2/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Sinusitis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Renal and urinary disorders Hydronephrosis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Renal and urinary disorders Ureterolithiasis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Subcutaneous Abscess	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Wound Infection Staphylococcal	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Nervous system disorders Syncope	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Pregnancy, puerperium and perinatal conditions Blighted Ovum	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Arthritis Bacterial	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Urinary Tract Infection	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Nervous system disorders Transient Ischemic Attack	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.

Other adverse events

Other adverse events
Measure	PF-05280586: by the End of Course 1 n=58 participants at risk This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU: by the End of Course 1 n=32 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 1 n=33 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US: by the End of Course 1 n=30 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 1 n=30 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586: by the End of Course 2 n=54 participants at risk This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU/PF-05280586: by the End of Course 2 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 2 n=31 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US/PF-05280586: by the End of Course 2 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 2 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586: by the End of Course 3 n=48 participants at risk This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	PF-05280586 (EU): by the End of Course 3 n=30 participants at risk This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.	Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3 n=27 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.	PF-05280586 (US): by the End of Course 3 n=29 participants at risk This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Gastrointestinal disorders Diarrhoea	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.3% 3/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	11.1% 3/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Nausea	3.4% 2/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 4/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.2% 3/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Vomiting	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.1% 2/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.5% 2/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
General disorders Asthenia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
General disorders Fatigue	5.2% 3/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	5.6% 3/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Upper Respiratory Tract Infection	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	9.4% 3/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	13.3% 4/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.3% 3/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	13.3% 4/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	14.8% 4/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.3% 3/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Urinary Tract Infection	6.9% 4/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	9.3% 5/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.4% 5/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.0% 3/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.0% 3/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Musculoskeletal and connective tissue disorders Back Pain	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.5% 2/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	6.9% 4/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	9.1% 3/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	9.3% 5/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	9.7% 3/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.4% 5/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.0% 3/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.0% 3/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Nervous system disorders Dizziness	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Nervous system disorders Headache	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Psychiatric disorders Depression	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.2% 3/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Respiratory, thoracic and mediastinal disorders Cough	3.4% 2/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	5.6% 3/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	4.2% 2/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
General disorders Oedema Peripheral	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	1.9% 1/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	11.1% 3/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Bronchitis	3.4% 2/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 4/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.4% 5/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	11.1% 3/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Nasopharyngitis	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.3% 3/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Oral Candidiasis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Sinusitis	1.7% 1/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 4/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.5% 2/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	8.3% 4/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Injury, poisoning and procedural complications Fall	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	2.1% 1/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	10.0% 3/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Investigations Neutrophil Count Decreased	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.1% 1/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.5% 2/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Nervous system disorders Paraesthesia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Gastrointestinal disorders Dyspepsia	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Gastroenteritis	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Gastrointestinal Viral Infection	3.4% 2/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 2/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.2% 3/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Infections and infestations Oral Herpes	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	7.4% 2/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.0% 1/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.2% 1/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Investigations Alanine Aminotransferase Increased	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.7% 1/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Investigations Aspartate Aminotransferase Increased	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.9% 2/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.
Investigations White Blood Cell Count Decreased	0.00% 0/58 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/32 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/33 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/54 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.3% 1/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/31 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/48 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	6.7% 2/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/30 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	0.00% 0/27 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.	3.4% 1/29 • Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit. SAEs \& AEs were summarized by course for events with first onset on or after the first dose of study drug in that course \& before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 \& 3.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo. Investigator will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
Publication restrictions are in place

Restriction type: OTHER