Trial Outcomes & Findings for Resolution of Sickle Cell Leg Ulcers With Voxelotor (NCT NCT05561140)

NCT ID: NCT05561140

Last Updated: 2025-07-09

Results Overview

An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was greater than equal to (\>=) 2 weeks and less than (\<) 6 months at screening; b) healed by \<25 percent (%) during the SOC run-in phase prior to randomization; c) size was greater than (\>2) square centimeters (cm\^2) at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be a responder.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: Through Week 12 of randomized treatment period
• Results posted on: 2025-07-09

Participant Flow

A total of 88 participants with sickle cell disease (SCD) were enrolled, randomized and treated with study drug for leg ulcers.

Eligible participants were randomized to receive study drug for 12 weeks in DB randomized period.Following this,eligible participants received voxelotor (delayed) for minimum 12 weeks in OL period. Participants were followed up for 4 weeks after last dose of study drug. All participants received the SOC per investigator/protocol for SCD leg ulcers.

Participant milestones

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC Participants were randomized to receive voxelotor 1500 milligram (mg) (3 tablets\*500 mg) orally once daily (OD) and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Randomized Treatment Period STARTED	45	43
Randomized Treatment Period COMPLETED	43	43
Randomized Treatment Period NOT COMPLETED	2	0
Open Label Treatment Period STARTED	43	43
Open Label Treatment Period COMPLETED	5	6
Open Label Treatment Period NOT COMPLETED	38	37

Reasons for withdrawal

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC Participants were randomized to receive voxelotor 1500 milligram (mg) (3 tablets\*500 mg) orally once daily (OD) and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Randomized Treatment Period Adverse Event	1	0
Randomized Treatment Period Withdrawal by Subject	1	0
Open Label Treatment Period Adverse Event	6	4
Open Label Treatment Period Lost to Follow-up	1	1
Open Label Treatment Period Physician Decision	0	1
Open Label Treatment Period Pregnancy	1	0
Open Label Treatment Period Study terminated by sponsor	29	30
Open Label Treatment Period Withdrawal by Subject	0	1
Open Label Treatment Period Other	1	0

Baseline Characteristics

Resolution of Sickle Cell Leg Ulcers With Voxelotor

Baseline characteristics by cohort

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=45 Participants Participants were randomized to receive voxelotor 1500 mg (3 tablets\*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=43 Participants Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Total n=88 Participants Total of all reporting groups
Age, Continuous	24.2 Years STANDARD_DEVIATION 7.61 • n=5 Participants	25.1 Years STANDARD_DEVIATION 8.53 • n=7 Participants	24.64 Years STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Week 12 of randomized treatment period

Population: Intention to treat (ITT) population included all randomized participants.

An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was greater than equal to (>=) 2 weeks and less than (<) 6 months at screening; b) healed by <25 percent (%) during the SOC run-in phase prior to randomization; c) size was greater than (>2) square centimeters (cm^2) at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be a responder.

Outcome measures

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=45 Participants Participants were randomized to receive voxelotor 1500 mg (3 tablets\*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=43 Participants Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Percentage of Participants Who Achieved Resolution of the Target Ulcers by Week 12 in Randomized Treatment Period	6.7 Percentage of participants Interval 1.4 to 18.3	7.0 Percentage of participants Interval 1.5 to 19.1

SECONDARY outcome

Timeframe: From Day 1 to censoring date before Week 12 or maximum up to Week 12 of randomized treatment period, whichever occurred first

Population: ITT population included all randomized participants.

An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization. Resolution of the target ulcer was defined as skin re-epithelialization confirmed at 2 consecutive study visits, 2 weeks apart during the 12-week randomized treatment period. Time to resolution of target ulcers was defined as the first time of the observed ulcer was resolved. For participants with more than one target ulcer, time to resolution of target ulcers was defined as time to the last target ulcer confirmed resolved. For participants who did not have the last target ulcer confirmed resolved by Week 12 or who were discontinued from study, the time to resolution was censored. Median time to event was evaluated using Kaplan-Meier method.

Outcome measures

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=45 Participants Participants were randomized to receive voxelotor 1500 mg (3 tablets\*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=43 Participants Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Time to Resolution of Target Ulcers up to Week 12 in Randomized Treatment Period	NA Days Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.	NA Days Median and 95% CI was not estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Week 12 of randomized treatment period

Population: ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

An ulcer qualified as a target ulcer, if met the following criteria: a) duration of ulcer was >=2 weeks and <6 months at screening; b) healed by <25% during the SOC run-in phase prior to randomization; c) size was >2 cm^2 at any visit, prior to randomization.

Outcome measures

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=35 Participants Participants were randomized to receive voxelotor 1500 mg (3 tablets\*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=38 Participants Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Change From Baseline in Total Surface Area of Target Ulcers at Week 12 in Randomized Treatment Period	-4.8 cm^2 Interval -10.0 to 0.4	3.4 cm^2 Interval -1.8 to 8.6

SECONDARY outcome

Timeframe: Through Week 12 of randomized treatment period

Population: ITT population included all randomized participants.

New ulcers were defined as ulcer(s) that were not captured at visit 1/screening. In this outcome measure, participants with occurrence of new ulcers during 12 weeks of treatment were considered.

Outcome measures

Measure	Voxelotor (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=45 Participants Participants were randomized to receive voxelotor 1500 mg (3 tablets\*500 mg) orally, OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, continued to receive voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.	Placebo (Blinded) + SOC Then Voxelotor (Open Label) + SOC n=43 Participants Participants were randomized to receive placebo matched to voxelotor, orally OD and SOC for 12 weeks in double blinded randomized treatment period. Eligible participants then in open label treatment period, received voxelotor 1500 mg (3 tablets\*500 mg) orally OD and SOC for minimum of 12 weeks.
Percentage of Participants With New Ulcers by Week 12 in Randomized Treatment Period	24.4 Percentage of participants Interval 12.9 to 39.5	32.6 Percentage of participants Interval 19.1 to 48.5

Adverse Events

Placebo, Blinded

Serious events: 14 serious events

Other events: 25 other events

Deaths: 0 deaths

Voxelotor, Blinded

Serious events: 18 serious events

Other events: 37 other events

Deaths: 1 deaths

Delayed Voxelotor, Open Label

Serious events: 25 serious events

Other events: 36 other events

Deaths: 4 deaths

Voxelotor, Open Label

Serious events: 30 serious events

Other events: 31 other events

Deaths: 6 deaths

Serious adverse events

Measure	Placebo, Blinded n=43 participants at risk Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period.	Voxelotor, Blinded n=45 participants at risk Participants who received voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily for 12 weeks in blinded treatment period.	Delayed Voxelotor, Open Label n=43 participants at risk Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily in open label treatment period.	Voxelotor, Open Label n=43 participants at risk Participants who received voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily in open label treatment period.
Infections and infestations Bacteraemia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Anaemia	16.3% 7/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	8.9% 4/45 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	16.3% 7/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.6% 5/43 • Number of events 5 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Pneumonia	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Haemolytic anaemia	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Leukocytosis	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholelithiasis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Hepatobiliary disorders Hepatic sequestration	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Bacterial infection	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.4% 2/45 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Infected skin ulcer	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Malaria	9.3% 4/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.4% 2/45 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	20.9% 9/43 • Number of events 13 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	23.3% 10/43 • Number of events 12 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Osteomyelitis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Sepsis	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.4% 2/45 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Tonsillitis	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Upper respiratory tract infection	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Gouty arthritis	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.2% 1/45 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Reproductive system and breast disorders Priapism	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Haemolysis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Peptic ulcer	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Cellulitis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Complicated malaria	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Cystitis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Gastroenteritis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Pharyngitis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Sinusitis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Skin infection	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Limb injury	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Wound complication	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Investigations Hepatitis C antibody positive	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Vascular disorders Deep vein thrombosis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Vascular disorders Hypotension	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Vascular disorders Hypovolaemic shock	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Dengue haemorrhagic fever	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	20.9% 9/43 • Number of events 9 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	28.9% 13/45 • Number of events 15 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	41.9% 18/43 • Number of events 40 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	53.5% 23/43 • Number of events 40 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.

Other adverse events

Measure	Placebo, Blinded n=43 participants at risk Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period.	Voxelotor, Blinded n=45 participants at risk Participants who received voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily for 12 weeks in blinded treatment period.	Delayed Voxelotor, Open Label n=43 participants at risk Participants who received placebo matched to voxelotor, orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily in open label treatment period.	Voxelotor, Open Label n=43 participants at risk Participants who received voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily for 12 weeks in blinded treatment period and then who received at least one dose of voxelotor 1500 mg (3 tablets\*500 mg) orally, once daily in open label treatment period.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	9.3% 4/43 • Number of events 5 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	28.9% 13/45 • Number of events 16 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	30.2% 13/43 • Number of events 18 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	23.3% 10/43 • Number of events 17 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Diarrhoea	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 9 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Nausea	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
General disorders Non-cardiac chest pain	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 5 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Gastroenteritis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
General disorders Pain	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
General disorders Pyrexia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholelithiasis	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Bacteraemia	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Infected skin ulcer	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	0.00% 0/45 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Malaria	11.6% 5/43 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.1% 5/45 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	20.9% 9/43 • Number of events 11 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	18.6% 8/43 • Number of events 15 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Infections and infestations Upper respiratory tract infection	9.3% 4/43 • Number of events 4 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.4% 2/45 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	2.3% 1/43 • Number of events 1 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.6% 5/43 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 1/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	17.8% 8/45 • Number of events 8 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	14.0% 6/43 • Number of events 10 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	16.3% 7/43 • Number of events 12 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/43 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	6.7% 3/45 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.6% 5/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	4.7% 2/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 1/43 • Number of events 2 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	17.8% 8/45 • Number of events 10 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	14.0% 6/43 • Number of events 8 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	14.0% 6/43 • Number of events 9 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Nervous system disorders Headache	7.0% 3/43 • Number of events 3 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.1% 5/45 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.6% 5/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Skin ulcer	23.3% 10/43 • Number of events 12 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	17.8% 8/45 • Number of events 11 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	20.9% 9/43 • Number of events 17 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 7 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Venous ulcer pain	7.0% 3/43 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	11.1% 5/45 • Number of events 6 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	9.3% 4/43 • Number of events 5 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.	7.0% 3/43 • Number of events 5 • Day 1 of dosing up to 4 weeks post last dose of study drug: maximum up to approximately 16 weeks for double blinded randomized treatment; maximum up to approximately 89.43 weeks for open label treatment Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as SAE in 1 participant and as non-SAE in another, or a participant may have experienced both the event. Data is reported for study intervention received by participants in the study. Safety-evaluable population included all randomized participants who received at least one dose of study intervention.

Additional Information

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Results disclosure agreements

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