Trial Outcomes & Findings for A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread (NCT NCT02322814)

NCT ID: NCT02322814

Last Updated: 2023-04-13

Results Overview

PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 169 participants
• Primary outcome timeframe: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)
• Results posted on: 2023-04-13

Participant Flow

The study recruited participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who had not received prior systemic therapy for metastatic breast cancer. Locally advanced disease must not have been amenable to resection with curative intent.

One participant from Cohort III never started any treatment.

Participant milestones

Measure	Cohort I: Safety Run-In Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Cobimetinib, Paclitaxel Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Overall Study STARTED	16	43	47	32	31
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	16	43	47	32	31

Reasons for withdrawal

Measure	Cohort I: Safety Run-In Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Cobimetinib, Paclitaxel Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Overall Study Death	7	29	32	23	14
Overall Study Lost to Follow-up	1	3	3	1	0
Overall Study Various Reasons	2	0	1	1	0
Overall Study Progressive Disease	0	0	0	1	1
Overall Study Protocol Violation	1	0	0	0	0
Overall Study Study Terminated by Sponsor	0	7	9	5	13
Overall Study Withdrawal by Subject	5	4	2	1	3

Baseline Characteristics

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Baseline characteristics by cohort

Measure	Cohort I: Safety Run-In n=16 Participants Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).	Cohort I: Placebo, Paclitaxel n=43 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Cobimetinib, Paclitaxel n=47 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=32 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=31 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Total n=169 Participants Total of all reporting groups
Age, Continuous	53.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants	52.9 Years STANDARD_DEVIATION 13.7 • n=7 Participants	54.2 Years STANDARD_DEVIATION 10.3 • n=5 Participants	53.7 Years STANDARD_DEVIATION 13.1 • n=4 Participants	52.2 Years STANDARD_DEVIATION 11.8 • n=21 Participants	53.4 Years STANDARD_DEVIATION 12.1 • n=8 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	43 Participants n=7 Participants	47 Participants n=5 Participants	32 Participants n=4 Participants	31 Participants n=21 Participants	169 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	35 Participants n=7 Participants	41 Participants n=5 Participants	30 Participants n=4 Participants	28 Participants n=21 Participants	147 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	30 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	28 Participants n=4 Participants	25 Participants n=21 Participants	129 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received. Data were only collected from participants in the Cohort I Expansion Stage (Cohort I: Cobimetinib, Paclitaxel, Cohort I: Placebo, Paclitaxel) for this outcome measure.

PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=47 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=43 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I: Progression-Free Survival, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	23.71 Weeks Interval 18.14 to 32.14	16.43 Weeks Interval 8.14 to 31.14	—	—	—

PRIMARY outcome

Timeframe: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 5.25 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received.

OR was defined as the rate of a PR or CR occurring after randomization and confirmed >=28 days later as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=32 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=31 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort II, III: Percentage of Participants With Confirmed Overall Response (OR) (Partial Response [PR] or Complete Response [CR]), as Determined by the Investigator Using RECIST v1.1 Responders	37.5 Percentage of participants	32.3 Percentage of participants	—	—	—
Cohort II, III: Percentage of Participants With Confirmed Overall Response (OR) (Partial Response [PR] or Complete Response [CR]), as Determined by the Investigator Using RECIST v1.1 Non-Responders	62.5 Percentage of participants	67.7 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Randomization up to death from any cause (up to approximately 6.5 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received. Data were only collected from participants in the Cohort I Expansion Stage (Cohort I: Cobimetinib, Paclitaxel, Cohort I: Placebo, Paclitaxel) along with the Cohort II and III for this outcome measure.

OS was defined as the time from randomization to death from any cause

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=47 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=43 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=32 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=31 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Overall Survival (OS)	16.72 Months Interval 13.5 to 20.24	19.58 Months Interval 14.75 to 29.37	11.04 Months Interval 9.53 to 22.51	15.57 Months Interval 14.26 to The upper limit of 95% CI was not evaluable due to insufficient events observed.	—

SECONDARY outcome

Timeframe: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received. Data were only collected from participants in the Cohort I Expansion Stage (Cohort I: Cobimetinib, Paclitaxel, Cohort I: Placebo, Paclitaxel) for this outcome measure.

OR was defined as the rate of a PR or CR occurring after randomization and confirmed >=28 days later as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=47 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=43 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I: Percentage of Participants With Confirmed OR (PR or CR), as Determined by the Investigator Using RECIST v1.1 Responders	38.3 Percentage of participants	20.9 Percentage of participants	—	—	—
Cohort I: Percentage of Participants With Confirmed OR (PR or CR), as Determined by the Investigator Using RECIST v1.1 Non-responders	61.7 Percentage of participants	79.1 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Time from the first occurrence of documented objective response to time of relapse or death, whichever occurs first (up to approximately 6.5 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received.

DOR was defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator using RECIST v1.1 or death from any cause during the study, whichever occurred first.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=16 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=47 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=43 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=32 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=31 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1	39.29 Months Interval 23.14 to 56.29	23.14 Months Interval 16.14 to 26.57	24.14 Months Interval 17.14 to The upper limit of 95% CI was not evaluable due to insufficient events observed.	5.78 Months Interval 4.44 to 16.33	11.42 Months Interval 5.78 to 17.94

SECONDARY outcome

Timeframe: Randomization up to disease progression or relapse, whichever occurs fist (up to approximately 6.5 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received. Data were only collected from participants in the Cohort I Expansion Stage (Cohort I: Cobimetinib, Paclitaxel, Cohort I: Placebo, Paclitaxel) along with the Cohort II and III for this outcome measure.

ORR_uc (ORR confirmation not required) was defined as the rate of a PR or CR occurring after randomization as determined by the investigator using RECIST v1.1, confirmation not required. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=47 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=43 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=32 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=31 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Percentage of Participants With Unconfirmed Overall Response (OR_uc) (Unconfirmed PR or CR), as Determined by the Investigator Using RECIST v1.1 Responders	42.6 Percentage of participants	25.6 Percentage of participants	46.9 Percentage of participants	45.2 Percentage of participants	—
Cohort I, II, III: Percentage of Participants With Unconfirmed Overall Response (OR_uc) (Unconfirmed PR or CR), as Determined by the Investigator Using RECIST v1.1 Non-Responders	57.4 Percentage of participants	74.4 Percentage of participants	53.1 Percentage of participants	54.8 Percentage of participants	—

SECONDARY outcome

Timeframe: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 6.5 years)

Population: ITT population was defined as all enrolled participants, whether or not the assigned study treatment was received.

PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=32 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=31 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort II, III: Progression-Free Survival, as Determined by Investigator Using RECIST v1.1	3.75 Months Interval 3.02 to 7.29	7.66 Months Interval 3.65 to 11.04	—	—	—

SECONDARY outcome

Timeframe: Randomization up to end of study (up to approximately 6.5 years)

Population: Safety-evaluable population was defined as participants who received any amount of any study drug.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=16 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=47 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=43 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=32 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=30 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Percentage of Participants With Adverse Events (AEs)	15 Participants	46 Participants	43 Participants	32 Participants	30 Participants

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hour [Hr] 0) on Cycle (Cy) 1 Day (D) 8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)

Population: The pharmacokinetic (PK) population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=11 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=8 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=17 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=15 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Maximum Plasma Concentration (Cmax) of Cobimetinib	285 Nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 62.2	266 Nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 82.0	213 Nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 68.0	407 Nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 90.7	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=13 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=38 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=14 Participants Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=13 Participants Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II, III: Minimum Plasma Concentration (Cmin) of Cobimetinib	65.6 ng/mL Geometric Coefficient of Variation 1279.5	130 ng/mL Geometric Coefficient of Variation 190.7	138 ng/mL Geometric Coefficient of Variation 79.0	136 ng/mL Geometric Coefficient of Variation 67.2	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Data were only collected from participants in the Cohort I: Safety Run-In stage for this outcome measure.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=11 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I: Area Under the Concentration-Time Curve From Time Zero to Dosing Interval (AUC0-tau; Total Exposure) of Cobimetinib	1620 Nanograms/milliliter/hour (hr*ng/mL) Geometric Coefficient of Variation 80.0	—	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Data were only collected from Cohort I: Safety Run-In and Cohort II participants for this outcome measure.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=11 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=14 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II: Cmax of Paclitaxel	1770 ng/mL Geometric Coefficient of Variation 553.4	283 ng/mL Geometric Coefficient of Variation 490.9	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Data were only collected from Cohort I: Safety Run-In and Cohort II participants for this outcome measure.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=13 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=15 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I, II: Cmin of Paclitaxel	1.40 ng/mL Geometric Coefficient of Variation 89.9	1.26 ng/mL Geometric Coefficient of Variation 53.3	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Data were only collected from participants in the Cohort I: Safety Run-In stage for this outcome measure.

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=10 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort I: AUC0-tau of Paclitaxel	4220 hr*ng/mL Geometric Coefficient of Variation 310.4	—	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=13 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort III: Cmax of Nab-Paclitaxel	277 ng/mL Geometric Coefficient of Variation 658.5	—	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=12 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort III: Cmin of Nab-Paclitaxel	2.05 ng/mL Geometric Coefficient of Variation 173.9	—	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Due to the sparse nature of PK sampling, the estimation of this PK parameter requires the use of population PK analysis. This would have enabled the exposure-response analysis with this OM. Given the outcome of the study, the Sponsors did not proceed with popPK analysis, which was planned, only if data warranted. AUC0-tau was not estimated and analyzed using the sparse PK samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Safety Run-In, Expansion:Predose (Hr0), 0.5Hr postdose (infusion duration:1Hr) on D1 of Cy1, 3; predose (Hr0) on D1 of Cy2, 4, 8, every 8 Cy up to end of treatment (EOT); 120 days after EOT (approximately 5.25 years) (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=10 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=10 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort II, III: Cmax (in Serum) of Atezolizumab	346 ng/mL Geometric Coefficient of Variation 48.3	374 ng/mL Geometric Coefficient of Variation 38.8	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT; 120 days after EOT (approximately 5.5 years) (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug

Outcome measures

Measure	Cohort I: Cobimetinib, Paclitaxel n=10 Participants Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Placebo, Paclitaxel n=10 Participants Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Cohort II, III: Cmin (in Serum) of Atezolizumab	144 ng/mL Geometric Coefficient of Variation 34.6	109 ng/mL Geometric Coefficient of Variation 89.9	—	—	—

SECONDARY outcome

Timeframe: Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT (approximately 5.5 years); 120 days after EOT (approximately 5.5 years) (Cy=28 days)

Population: The PK population included all participants with evaluable PK data who received at least one dose of study drug. Due to the sparse nature of PK sampling, the estimation of this PK parameter requires the use of population PK analysis. This would have enabled the exposure-response analysis with this OM. Given the outcome of the study, the Sponsors did not proceed with popPK analysis, which was planned, only if data warranted. AUC0-tau was not estimated and analyzed using the sparse PK samples.

Outcome measures

Outcome data not reported

Adverse Events

Cohort I: Safety Run-In

Serious events: 6 serious events

Other events: 15 other events

Deaths: 7 deaths

Cohort I: Placebo, Paclitaxel

Serious events: 8 serious events

Other events: 43 other events

Deaths: 29 deaths

Cohort I: Cobimetinib, Paclitaxel

Serious events: 17 serious events

Other events: 46 other events

Deaths: 32 deaths

Cohort II:Cobimetinib,Paclitaxel,Atezolizumab

Serious events: 16 serious events

Other events: 32 other events

Deaths: 23 deaths

Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab

Serious events: 15 serious events

Other events: 29 other events

Deaths: 14 deaths

Serious adverse events

Measure	Cohort I: Safety Run-In n=16 participants at risk Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).	Cohort I: Placebo, Paclitaxel n=43 participants at risk Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Cobimetinib, Paclitaxel n=47 participants at risk Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=32 participants at risk Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=30 participants at risk Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Gastrointestinal disorders NAUSEA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders BRAIN OEDEMA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Cardiac disorders CARDIAC ARREST	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Cardiac disorders CARDIAC FAILURE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Cardiac disorders MITRAL VALVE INCOMPETENCE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders PAPILLOEDEMA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders DIARRHOEA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders GASTRIC PERFORATION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders VOMITING	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders ASTHENIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders FATIGUE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders MUCOSAL INFLAMMATION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders PYREXIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations CELLULITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations ERYSIPELAS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations HERPES ZOSTER	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations KIDNEY INFECTION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations MASTITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PERIORBITAL CELLULITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PNEUMONIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations SEPSIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations STREPTOCOCCAL SEPSIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD CREATININE INCREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders OPTIC NEURITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders PARTIAL SEIZURES	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders PRESYNCOPE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders SYNCOPE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders RASH	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders EMBOLISM	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders EMBOLISM VENOUS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders ORTHOSTATIC HYPOTENSION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.

Other adverse events

Measure	Cohort I: Safety Run-In n=16 participants at risk Participants received cobimetinib plus paclitaxel until 12 participants completed one cycle of study treatment (28 days).	Cohort I: Placebo, Paclitaxel n=43 participants at risk Participants received a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort I: Cobimetinib, Paclitaxel n=47 participants at risk Participants received a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort II:Cobimetinib,Paclitaxel,Atezolizumab n=32 participants at risk Participants received cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.	Cohort III: Cobimetinib, Nab-Paclitaxel, Atezolizumab n=30 participants at risk Participants received cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Eye disorders MACULAR FIBROSIS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders ANAEMIA	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.0% 6/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.5% 12/47 • Number of events 16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	43.8% 14/32 • Number of events 19 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	33.3% 10/30 • Number of events 24 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders EOSINOPHILIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders LEUKOPENIA	6.2% 1/16 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Blood and lymphatic system disorders NEUTROPENIA	12.5% 2/16 • Number of events 16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	30.2% 13/43 • Number of events 43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	17.0% 8/47 • Number of events 21 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.8% 6/32 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	26.7% 8/30 • Number of events 18 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Cardiac disorders PALPITATIONS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Cardiac disorders TACHYCARDIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Ear and labyrinth disorders TINNITUS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders CATARACT	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders CATARACT CORTICAL	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders CHORIORETINOPATHY	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders DRY EYE	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders EPISCLERITIS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders EYE PAIN	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders EYELID OEDEMA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders MACULAR OEDEMA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders RETINAL DETACHMENT	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders RETINAL DRUSEN	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders VISION BLURRED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	21.3% 10/47 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Eye disorders VITREOUS FLOATERS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders ABDOMINAL DISTENSION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders ABDOMINAL PAIN	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.6% 5/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.8% 6/32 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.3% 4/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders APHTHOUS ULCER	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders CONSTIPATION	25.0% 4/16 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.9% 9/43 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	17.0% 8/47 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.8% 6/32 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	26.7% 8/30 • Number of events 13 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders DIARRHOEA	62.5% 10/16 • Number of events 29 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	30.2% 13/43 • Number of events 19 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	76.6% 36/47 • Number of events 66 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	65.6% 21/32 • Number of events 48 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	90.0% 27/30 • Number of events 55 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders DRY MOUTH	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	12.5% 2/16 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders HAEMORRHOIDS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders NAUSEA	43.8% 7/16 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	41.9% 18/43 • Number of events 25 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	42.6% 20/47 • Number of events 24 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	40.6% 13/32 • Number of events 18 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	50.0% 15/30 • Number of events 20 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders STOMATITIS	31.2% 5/16 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	11.6% 5/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	27.7% 13/47 • Number of events 18 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Gastrointestinal disorders VOMITING	31.2% 5/16 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.3% 7/43 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	17.0% 8/47 • Number of events 13 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	28.1% 9/32 • Number of events 16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	40.0% 12/30 • Number of events 16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders ASTHENIA	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.6% 11/43 • Number of events 18 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	27.7% 13/47 • Number of events 15 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.8% 6/32 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.0% 6/30 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders CHEST PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.3% 7/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.6% 5/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders CHILLS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders FATIGUE	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	34.9% 15/43 • Number of events 19 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	27.7% 13/47 • Number of events 15 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	34.4% 11/32 • Number of events 16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	33.3% 10/30 • Number of events 10 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders GAIT DISTURBANCE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders GENERALISED OEDEMA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders MUCOSAL INFLAMMATION	6.2% 1/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders OEDEMA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.6% 5/47 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders OEDEMA PERIPHERAL	25.0% 4/16 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.9% 9/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	19.1% 9/47 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	21.9% 7/32 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders PAIN	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders PERIPHERAL SWELLING	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
General disorders PYREXIA	25.0% 4/16 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.6% 8/43 • Number of events 13 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	19.1% 9/47 • Number of events 15 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	30.0% 9/30 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations CELLULITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations CYSTITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations FURUNCLE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations IMPETIGO	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations INFLUENZA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations LARYNGITIS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations LOCALISED INFECTION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations LYMPHANGITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations NAIL INFECTION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations NASOPHARYNGITIS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations ORAL HERPES	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PARONYCHIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PHARYNGITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations PNEUMONIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations RASH PUSTULAR	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations SINUSITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	12.5% 2/16 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.3% 4/43 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations URINARY TRACT INFECTION	12.5% 2/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	23.3% 7/30 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Infections and infestations VAGINAL INFECTION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Injury, poisoning and procedural complications CHEST INJURY	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	12.5% 2/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations ALANINE AMINOTRANSFERASE INCREASED	12.5% 2/16 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.0% 6/30 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	18.8% 3/16 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	37.5% 6/16 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	21.3% 10/47 • Number of events 10 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	23.3% 7/30 • Number of events 13 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD POTASSIUM DECREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD PRESSURE INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations BLOOD THYROID STIMULATING HORMONE INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations C-REACTIVE PROTEIN INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations CARBOHYDRATE ANTIGEN 15-3 INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations EJECTION FRACTION DECREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations FIBRIN D DIMER INCREASED	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations HAEMOGLOBIN DECREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations MYOGLOBIN BLOOD INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations NEUTROPHIL COUNT INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations PLATELET COUNT DECREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations SERUM FERRITIN INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations TRANSFERRIN SATURATION DECREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations WEIGHT DECREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Investigations WHITE BLOOD CELL COUNT INCREASED	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders DECREASED APPETITE	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	23.3% 10/43 • Number of events 14 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	19.1% 9/47 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders DEHYDRATION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders DIABETES MELLITUS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.6% 5/47 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders ARTHRALGIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.3% 7/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders BACK PAIN	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders BONE PAIN	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.3% 4/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders JOINT SWELLING	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders MYALGIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.0% 6/43 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	11.6% 5/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders DIZZINESS	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.6% 8/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.9% 7/47 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders DYSGEUSIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.3% 4/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.9% 7/47 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders DYSMETRIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders DYSTONIC TREMOR	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders HEADACHE	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.9% 9/43 • Number of events 14 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.9% 7/47 • Number of events 14 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	15.6% 5/32 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders HYPOAESTHESIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders HYPOGEUSIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders NEUROPATHY PERIPHERAL	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.3% 7/43 • Number of events 10 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.0% 8/32 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	23.3% 7/30 • Number of events 11 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders NEUROTOXICITY	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders PARAESTHESIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	11.6% 5/43 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.9% 9/43 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	17.0% 8/47 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Psychiatric disorders ANXIETY	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Psychiatric disorders INSOMNIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.3% 7/43 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Renal and urinary disorders DYSURIA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Renal and urinary disorders HAEMATURIA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Reproductive system and breast disorders BREAST PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Reproductive system and breast disorders CYSTOCELE	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders COUGH	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	27.9% 12/43 • Number of events 14 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.9% 7/47 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	18.8% 6/32 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	25.0% 4/16 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	14.9% 7/47 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.3% 4/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	21.9% 7/32 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	23.3% 7/30 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders NASAL DRYNESS	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders ALOPECIA	31.2% 5/16 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	44.2% 19/43 • Number of events 20 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	44.7% 21/47 • Number of events 22 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.0% 8/32 • Number of events 8 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	33.3% 10/30 • Number of events 10 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	18.8% 3/16 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	19.1% 9/47 • Number of events 12 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.0% 8/32 • Number of events 14 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	20.0% 6/30 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders DRY SKIN	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.8% 6/47 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	16.7% 5/30 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders ERYTHEMA	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.3% 2/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	10.0% 3/30 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	6.2% 1/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders INGROWING NAIL	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders NAIL RIDGING	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders ONYCHOMADESIS	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	6.2% 1/16 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders PRURITUS	12.5% 2/16 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	25.5% 12/47 • Number of events 17 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	12.5% 4/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	13.3% 4/30 • Number of events 9 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders RASH	50.0% 8/16 • Number of events 18 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	11.6% 5/43 • Number of events 6 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	46.8% 22/47 • Number of events 34 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	37.5% 12/32 • Number of events 22 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	56.7% 17/30 • Number of events 22 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders RASH PAPULAR	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders SKIN FISSURES	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.4% 3/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Skin and subcutaneous tissue disorders SKIN LESION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/43 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/32 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders FLUSHING	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/30 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders HOT FLUSH	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	4.7% 2/43 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.1% 1/47 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders HYPERTENSION	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	7.0% 3/43 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 7 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.1% 1/32 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders HYPOTENSION	6.2% 1/16 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	0.00% 0/47 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.2% 2/32 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	3.3% 1/30 • Number of events 1 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.
Vascular disorders LYMPHOEDEMA	0.00% 0/16 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	2.3% 1/43 • Number of events 3 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	8.5% 4/47 • Number of events 4 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	9.4% 3/32 • Number of events 5 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.	6.7% 2/30 • Number of events 2 • From randomization up until 6.5 years The All-Cause Mortality table displays information from the ITT population which included all enrolled participants, whether or not the assigned study treatment was received. One participant in Cohort III didn't receive study treatment and is not counted in the AE tables. The safety-evaluable population was defined as participants who received any amount of any study drug. The Serious and Other Adverse Events are reported with data from the safety-evaluable population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER