Trial Outcomes & Findings for Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (NCT NCT03334851)

NCT ID: NCT03334851

Last Updated: 2023-10-30

Results Overview

DLT was defined as any of the following events meeting the criteria: (1) \>=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 74 participants
• Primary outcome timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
• Results posted on: 2023-10-30

Participant Flow

This study included two parts: Part A, consisting of 7 single ascending dose (SAD) cohorts (placebo and PF-06835375 0.03 mg, 0.1 mg, 0.3 mg, 1 mg, 3 mg, 6 mg); and Part B, consisting 6 multiple ascending dose (MAD) cohorts (placebo and PF-06835375 0.3 mg, 1 mg, 3 mg, 6 mg, 10 mg). In Part A (SAD), 32 participants were assigned to treatment, 1 of whom was not treated. In Part B (MAD), 42 participants were screened and treated.

Participant milestones

Measure	Placebo IV SAD Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.	PF-06835375 0.03 mg IV SAD Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	Placebo SC MAD Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Overall Study STARTED	8	3	3	3	3	6	5	11	6	6	7	6	6
Overall Study COMPLETED	8	3	3	3	3	6	5	9	6	6	4	5	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	2	0	0	3	1	1

Reasons for withdrawal

Measure	Placebo IV SAD Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.	PF-06835375 0.03 mg IV SAD Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	Placebo SC MAD Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Overall Study Other	0	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Adverse Event	0	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	1	0	1
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	2	1	0

Baseline Characteristics

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Placebo IV SAD n=8 Participants Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.	PF-06835375 0.03 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	Placebo SC MAD n=11 Participants Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	Total n=73 Participants Total of all reporting groups
Age, Continuous	50.00 Years STANDARD_DEVIATION 11.58 • n=5 Participants	53.33 Years STANDARD_DEVIATION 11.02 • n=7 Participants	47.33 Years STANDARD_DEVIATION 15.53 • n=5 Participants	57.33 Years STANDARD_DEVIATION 6.03 • n=4 Participants	54.00 Years STANDARD_DEVIATION 10.15 • n=21 Participants	52.33 Years STANDARD_DEVIATION 13.95 • n=8 Participants	54.00 Years STANDARD_DEVIATION 5.66 • n=8 Participants	48.64 Years STANDARD_DEVIATION 13.60 • n=24 Participants	52.00 Years STANDARD_DEVIATION 10.56 • n=42 Participants	54.17 Years STANDARD_DEVIATION 7.70 • n=42 Participants	53.57 Years STANDARD_DEVIATION 8.20 • n=42 Participants	61.67 Years STANDARD_DEVIATION 10.80 • n=42 Participants	58.50 Years STANDARD_DEVIATION 9.25 • n=36 Participants	53.26 Years STANDARD_DEVIATION 10.71 • n=36 Participants
Age, Customized <18	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Age, Customized 18-44	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	15 Participants n=36 Participants
Age, Customized 45-64	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	6 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=36 Participants	48 Participants n=36 Participants
Age, Customized >=65	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	10 Participants n=36 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	5 Participants n=8 Participants	11 Participants n=24 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=36 Participants	65 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=36 Participants	8 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	10 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	9 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=36 Participants	63 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	15 Participants n=36 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	9 Participants n=24 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=36 Participants	54 Participants n=36 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

DLT was defined as any of the following events meeting the criteria: (1) >=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Mild (all causalities)	1 Participants	1 Participants	3 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	4 Participants	2 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Moderate (all causalities)	4 Participants	3 Participants	3 Participants	4 Participants	2 Participants	2 Participants	2 Participants	3 Participants	3 Participants	4 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Severe (all causalities)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Mild (treatment-related)	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	4 Participants	1 Participants	3 Participants	3 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Moderate (treatment-related)	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity Severe (treatment-related)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With All-Causality and Treatment-Related TEAEs Number of Participants with all-causality TEAEs	5 Participants	4 Participants	6 Participants	8 Participants	3 Participants	3 Participants	2 Participants	3 Participants	6 Participants	5 Participants	9 Participants	4 Participants	4 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of Participants with all-causality SAEs	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of Participants with treatment-related TEAEs	5 Participants	2 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants	6 Participants	3 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of Participants with treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Permanent Discontinuation Due to TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein and creatine kinase. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy and creatinine. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was the last pre-dose measurement (first treatment for MAD cohorts).

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Elevated creatine phosphokinase (CPK)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Elevated liver enzymes (AST and ALT increased)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Elevated liver function tests (AST and ALT increased)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; standing pulse rate <40 bpm or >120 bpm; sitting systolic blood pressure (BP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg; sitting diastolic BP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg. Baseline was defined as the last pre-dose measurement in Day 1. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Sitting Diastolic BP <50 mmHg	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Sitting Systolic BP <90 mmHg	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Maximum Increase from Baseline in Sitting Systolic BP >= 30 mmHg	3 Participants	0 Participants	1 Participants	4 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Maximum Decrease from Baseline in Sitting Systolic BP >= 30 mmHg	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	0 Participants	2 Participants
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Maximum Increase from Baseline in Sitting Diastolic BP >= 20 mmHg	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria Maximum Decrease from Baseline in Sitting Diastolic BP >= 20 mmHg	2 Participants	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants	4 Participants	2 Participants	4 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

ECG abnormalities criteria included: 1) maximum QTc interval (ms): 450<= QTc <480, 480<= QTc <500, and QTc >=500; QTc maximum increase from baseline (ms): 30<= change <60, and change >=60; 2) maximum PR interval (ms): >=300; PR increase from baseline (ms): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (ms): >=140; QRS increase from baseline (ms) >=50%. QTcF indicates QT interval corrected using the Fridericia's formula. QTcB indicates QT interval corrected using the Bazett's formula. Baseline was defined as the average of the triplicate pre-dose recordings at Day 1. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria Maximum QRS (ms) >=140	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 450<= Maximum QTcB Interval (ms) <480	3 Participants	2 Participants	3 Participants	4 Participants	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants	3 Participants	6 Participants	1 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 480<= Maximum QTcB Interval (ms) <500	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria Maximum QTcB Interval (ms) >=500	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 450<= Maximum QTcF Interval (ms) <480	3 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 30<= QTcF Maximum Increase From Baseline (ms) <60	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 480<= Maximum QTcF Interval (ms) <500	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria 30<= QTcB Maximum Increase From Baseline (ms) <60	0 Participants	2 Participants	3 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	4 Participants	3 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. The incidence of AEs by system organ class "infections and infestations" was reported here.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With All-Causality and Treatment-Related Infections and Infestations Number of Participants with all-causality Infections and Infestations	2 Participants	0 Participants	2 Participants	4 Participants	2 Participants	3 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With All-Causality and Treatment-Related Infections and Infestations Number of Participants with treatment-related Infections and Infestations	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.

Blood samples for the assessment of B cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375	99.287 Percentage of decrease from baseline Geometric Coefficient of Variation 0.6300	99.278 Percentage of decrease from baseline Geometric Coefficient of Variation 1.4476	99.134 Percentage of decrease from baseline Geometric Coefficient of Variation 0.9983	37.693 Percentage of decrease from baseline Geometric Coefficient of Variation 43.0477	67.283 Percentage of decrease from baseline Geometric Coefficient of Variation 29.3555	84.978 Percentage of decrease from baseline Geometric Coefficient of Variation 5.9053	94.052 Percentage of decrease from baseline Geometric Coefficient of Variation 2.4246	98.546 Percentage of decrease from baseline Geometric Coefficient of Variation 0.1627	98.588 Percentage of decrease from baseline Geometric Coefficient of Variation 1.0295	99.326 Percentage of decrease from baseline Geometric Coefficient of Variation 0.3272	41.854 Percentage of decrease from baseline Geometric Coefficient of Variation 52.5341	91.056 Percentage of decrease from baseline Geometric Coefficient of Variation 12.6425	99.650 Percentage of decrease from baseline Geometric Coefficient of Variation 0.4036

SECONDARY outcome

Timeframe: Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.

Blood samples for the assessment of circulating follicular T helper like (cTfh) cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=8 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=5 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=11 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375	96.683 Percentage of decrease from baseline Geometric Coefficient of Variation 1.8503	97.721 Percentage of decrease from baseline Geometric Coefficient of Variation 1.6523	98.118 Percentage of decrease from baseline Geometric Coefficient of Variation 0.8825	45.227 Percentage of decrease from baseline Geometric Coefficient of Variation 48.6385	62.360 Percentage of decrease from baseline Geometric Coefficient of Variation 23.1206	84.994 Percentage of decrease from baseline Geometric Coefficient of Variation 11.2007	89.324 Percentage of decrease from baseline Geometric Coefficient of Variation 6.3399	98.675 Percentage of decrease from baseline Geometric Coefficient of Variation 1.2762	97.283 Percentage of decrease from baseline Geometric Coefficient of Variation 3.0481	97.789 Percentage of decrease from baseline Geometric Coefficient of Variation 3.1257	58.116 Percentage of decrease from baseline Geometric Coefficient of Variation 52.5069	89.540 Percentage of decrease from baseline Geometric Coefficient of Variation 14.8599	95.442 Percentage of decrease from baseline Geometric Coefficient of Variation 5.3905

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=1 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD)	—	—	—	NA nanogram/milliliter (ng/mL) Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	NA nanogram/milliliter (ng/mL) Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	103.0 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 197	208.7 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 28	994.7 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 29	2645 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 13	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=1 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD)	—	—	—	NA hour (hr) NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	NA hour (hr) NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	2.17 hour (hr) Interval 2.15 to 2.2	2.08 hour (hr) Interval 2.07 to 4.15	2.24 hour (hr) Interval 2.17 to 4.12	3.96 hour (hr) Interval 2.0 to 8.12	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD)	—	—	—	NA nanogram*hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	—	1573 nanogram*hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation 2409	7467 nanogram*hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation 84	88190 nanogram*hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation 35	288000 nanogram*hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation 30	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=1 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD)	—	—	—	NA ng*hr/mL Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	NA ng*hr/mL Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	1380 ng*hr/mL Geometric Coefficient of Variation 2950	7327 ng*hr/mL Geometric Coefficient of Variation 85	87120 ng*hr/mL Geometric Coefficient of Variation 36	287400 ng*hr/mL Geometric Coefficient of Variation 30	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=7 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 1	—	—	—	5.743 ng/mL Geometric Coefficient of Variation 148	34.82 ng/mL Geometric Coefficient of Variation 79	77.72 ng/mL Geometric Coefficient of Variation 150	257.8 ng/mL Geometric Coefficient of Variation 204	—	—	—	—	—	—
Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 29	—	—	—	26.92 ng/mL Geometric Coefficient of Variation 68	89.68 ng/mL Geometric Coefficient of Variation 93	209.6 ng/mL Geometric Coefficient of Variation 115	262.1 ng/mL Geometric Coefficient of Variation 224	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=7 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 1	—	—	—	170 hr Interval 67.4 to 170.0	168 hr Interval 72.7 to 361.0	169 hr Interval 73.3 to 192.0	144 hr Interval 47.7 to 172.0	—	—	—	—	—	—
Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 29	—	—	—	169 hr Interval 168.0 to 169.0	169 hr Interval 123.0 to 337.0	171 hr Interval 120.0 to 336.0	121 hr Interval 7.55 to 169.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

AUCtau is area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau= 28 days. AUCtau for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=7 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 1	—	—	—	1964 ng*hr/mL Geometric Coefficient of Variation 130	11010 ng*hr/mL Geometric Coefficient of Variation 84	28070 ng*hr/mL Geometric Coefficient of Variation 251	70630 ng*hr/mL Geometric Coefficient of Variation 202	—	—	—	—	—	—
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) Day 29	—	—	—	9309 ng*hr/mL Geometric Coefficient of Variation 62	25610 ng*hr/mL Geometric Coefficient of Variation 125	76450 ng*hr/mL Geometric Coefficient of Variation 142	88540 ng*hr/mL Geometric Coefficient of Variation 154	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=7 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
AUClast of PF-06835375 Following Multiple Doses in Part B (MAD)	—	—	—	9346 ng*hr/mL Geometric Coefficient of Variation 61	22050 ng*hr/mL Geometric Coefficient of Variation 146	84370 ng*hr/mL Geometric Coefficient of Variation 160	96610 ng*hr/mL Geometric Coefficient of Variation 141	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Cmin is minimum observed serum trough concentration. Cmin was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD)	—	—	—	NA ng/mL Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated	6.075 ng/mL Geometric Coefficient of Variation 80	11.81 ng/mL Geometric Coefficient of Variation 434	9.410 ng/mL Geometric Coefficient of Variation 199	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

Rac is observed accumulation ratio. Rac = Day 29 AUCtau / Day 1 AUCtau. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=4 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD)	—	—	—	NA ratio Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	2.410 ratio Geometric Coefficient of Variation 74	2.977 ratio Geometric Coefficient of Variation 79	2.001 ratio Geometric Coefficient of Variation 209	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates

Population: All enrolled participants treated who had at least 1 of the PK parameters of interest.

PTF is peak-to-trough fluctuation at steady state. PTF = (Cmax-Cmin)/Cav. Cav is average serum concentration. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.

Outcome measures

Measure	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=2 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD)	—	—	—	NA ratio Geometric Coefficient of Variation NA NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.	2.037 ratio Geometric Coefficient of Variation 26	1.687 ratio Geometric Coefficient of Variation 31	1.830 ratio Geometric Coefficient of Variation 35	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, 15, 29, 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Population: All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.

To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375.

Outcome measures

Measure	PF-06835375 3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.03 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 Participants Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 Participants Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=5 Participants Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=7 Participants Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 Participants Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375 Number of ADA or NAb evaluable participants with positive ADA	2 Participants	—	—	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants	3 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375 Number of ADA or NAb evaluable participants with positive NAb	2 Participants	—	—	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants

Adverse Events

Placebo IV SAD

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

PF-06835375 0.03 mg IV SAD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06835375 0.1 mg IV SAD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06835375 0.3 mg IV SAD

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-06835375 1 mg IV SAD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06835375 3 mg IV SAD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

PF-06835375 6 mg IV SAD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo SC MAD

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

PF-06835375 0.3 mg SC MAD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-06835375 1 mg SC MAD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-06835375 3 mg SC MAD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

PF-06835375 6 mg SC MAD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-06835375 10 mg SC MAD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo IV SAD n=8 participants at risk Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.	PF-06835375 0.03 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 participants at risk Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=5 participants at risk Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	Placebo SC MAD n=11 participants at risk Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.3 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=7 participants at risk Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.
Cardiac disorders Acute myocardial infarction	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Cardiac disorders Arteriosclerosis coronary artery	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Chest pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Vascular disorders Hypertension	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Other adverse events

Measure	Placebo IV SAD n=8 participants at risk Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.	PF-06835375 0.03 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.	PF-06835375 0.1 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.	PF-06835375 0.3 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.	PF-06835375 1 mg IV SAD n=3 participants at risk Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.	PF-06835375 3 mg IV SAD n=6 participants at risk Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.	PF-06835375 6 mg IV SAD n=5 participants at risk Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.	Placebo SC MAD n=11 participants at risk Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 0.3 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 1 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 3 mg SC MAD n=7 participants at risk Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 6 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.	PF-06835375 10 mg SC MAD n=6 participants at risk Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.
General disorders Vaccination site induration	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Vaccination site nodule	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Vaccination site pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Vaccination site swelling	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Vaccination site warmth	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Hepatobiliary disorders Cholelithiasis	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Hepatobiliary disorders Gallbladder disorder	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Immune system disorders Allergy to vaccine	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Acute sinusitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Bacterial vulvovaginitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Gastroenteritis viral	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Gastrointestinal viral infection	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	40.0% 2/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Cardiac disorders Palpitations	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Cardiac disorders Sinus tachycardia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Cardiac disorders Tachycardia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	28.6% 2/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Eye disorders Eye irritation	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Lip swelling	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Nausea	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Vomiting	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Chest discomfort	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Chills	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	28.6% 2/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Feeling hot	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Influenza like illness	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site bruising	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site pruritus	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site scab	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site swelling	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Pyrexia	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	66.7% 2/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	42.9% 3/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Immune system disorders Cytokine release syndrome	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Immune system disorders Hypersensitivity	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Upper respiratory tract infection	25.0% 2/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Contusion	25.0% 2/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Investigations Electrocardiogram T wave amplitude decreased	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Investigations Heart rate increased	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Investigations Hepatic enzyme increased	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Dizziness	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Dysgeusia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Headache	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	66.7% 4/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	40.0% 2/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	18.2% 2/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Psychiatric disorders Confusional state	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Pollakiuria	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Vascular disorders Flushing	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Vascular disorders Hypertension	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Vascular disorders Hypotension	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	28.6% 2/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Cardiac disorders Angina pectoris	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Ear and labyrinth disorders Ear pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Eye disorders Keratitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Eye disorders Ocular hyperaemia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Anal haemorrhage	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Colitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Dry mouth	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Dysphagia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Gastrooesophageal reflux disease	25.0% 2/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Haemorrhoids	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Melaena	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Disease progression	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Fatigue	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site erythema	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Injection site reaction	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Malaise	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Mass	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Oedema peripheral	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Swelling	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Tenderness	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
General disorders Vaccination site erythema	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	27.3% 3/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Herpes simplex	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Influenza	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Nasopharyngitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Oral herpes	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Otitis media	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Sinusitis	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Tonsillitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Tooth abscess	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Urinary tract infection	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	66.7% 2/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 2/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Viral infection	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	40.0% 2/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Fall	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Ligament sprain	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Muscle strain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	20.0% 1/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Injury, poisoning and procedural complications Vaccination complication	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	28.6% 2/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Investigations Blood creatine phosphokinase increased	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Investigations Liver function test increased	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Metabolism and nutrition disorders Hypercholesterolaemia	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Metabolism and nutrition disorders Hypocalcaemia	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Migraine	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Paraesthesia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Nervous system disorders Presyncope	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Product Issues Device malfunction	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Psychiatric disorders Depression	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Psychiatric disorders Hallucination, visual	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Psychiatric disorders Insomnia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Haematuria	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Hydronephrosis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Hypercalciuria	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Nocturia	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Renal colic	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Renal and urinary disorders Stag horn calculus	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	14.3% 1/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	9.1% 1/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Surgical and medical procedures Tooth extraction	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	33.3% 1/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Vascular disorders Thrombosis	0.00% 0/8 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/3 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/5 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/11 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/7 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	16.7% 1/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)	0.00% 0/6 • From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER