Trial Outcomes & Findings for Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy (NCT NCT00470834)

NCT ID: NCT00470834

Last Updated: 2017-02-27

Results Overview

Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter \[ng/mL\] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 127 participants
• Primary outcome timeframe: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
• Results posted on: 2017-02-27

Participant Flow

Participant milestones

Measure	Bicalutamide 50 mg/Placebo Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Treatment Period (18 Months) STARTED	65	62
Treatment Period (18 Months) COMPLETED	27	31
Treatment Period (18 Months) NOT COMPLETED	38	31
Extension Period (24 Months) STARTED	26	30
Extension Period (24 Months) COMPLETED	11	7
Extension Period (24 Months) NOT COMPLETED	15	23

Reasons for withdrawal

Measure	Bicalutamide 50 mg/Placebo Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Treatment Period (18 Months) Protocol-defined Stopping Criteria	16	14
Treatment Period (18 Months) Adverse Event	7	6
Treatment Period (18 Months) Withdrawal by Subject	4	5
Treatment Period (18 Months) Physician Decision	4	4
Treatment Period (18 Months) Protocol Violation	3	1
Treatment Period (18 Months) Sponsor Terminated Study	1	1
Treatment Period (18 Months) Lost to Follow-up	1	0
Treatment Period (18 Months) Non-compliance	1	0
Treatment Period (18 Months) Lack of Efficacy	1	0
Extension Period (24 Months) Protocol-defined Stopping Criteria	6	7
Extension Period (24 Months) Adverse Event	3	4
Extension Period (24 Months) Withdrawal by Subject	2	5
Extension Period (24 Months) Physician Decision	4	3
Extension Period (24 Months) Sponsor Terminated Study	0	1
Extension Period (24 Months) Lost to Follow-up	0	1
Extension Period (24 Months) Non-compliance	0	1
Extension Period (24 Months) Disease Progression	0	1

Baseline Characteristics

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

Baseline characteristics by cohort

Measure	Bicalutamide 50 mg/Placebo n=65 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Total n=127 Participants Total of all reporting groups
Age, Continuous	77.6 Years STANDARD_DEVIATION 7.90 • n=5 Participants	78.9 Years STANDARD_DEVIATION 5.94 • n=7 Participants	78.3 Years STANDARD_DEVIATION 7.02 • n=5 Participants
Gender Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Male	65 Participants n=5 Participants	62 Participants n=7 Participants	127 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)

Population: Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).

Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

Outcome measures

Measure	Bicalutamide 50 mg/Placebo n=41 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=40 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Time to Disease Progression	376.9 Days Standard Deviation 333.94	433.1 Days Standard Deviation 324.25

SECONDARY outcome

Timeframe: Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)

Population: ITT Population. Data were not summarized for censored participants (no treatment failure).

Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

Outcome measures

Measure	Bicalutamide 50 mg/Placebo n=31 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=28 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Time to Treatment Failure	368.4 Days Standard Deviation 323.94	457.5 Days Standard Deviation 322.01

SECONDARY outcome

Timeframe: Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)

Population: ITT Population

PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.

Outcome measures

Measure	Bicalutamide 50 mg/Placebo n=65 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Number of Participants With PSA Response Overall (Months 1-42), n=65, 62	37 participants	38 participants
Number of Participants With PSA Response Months 1-18, n=65, 62	37 participants	38 participants
Number of Participants With PSA Response Months 19-42, n=4, 7	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Months 6, 12, 18, 21, and 42

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Bicalutamide 50 mg/Placebo n=65 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Month 6, n=62, 61	-2.0 Nanograms per milliliter (ng/mL) Interval -12.4 to 74.0	-2.2 Nanograms per milliliter (ng/mL) Interval -17.6 to 15.0
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Month 12, n=62, 61	-1.7 Nanograms per milliliter (ng/mL) Interval -12.5 to 74.0	-2.1 Nanograms per milliliter (ng/mL) Interval -17.7 to 33.6
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Month 18, n=62, 61	-1.2 Nanograms per milliliter (ng/mL) Interval -12.7 to 74.0	-1.7 Nanograms per milliliter (ng/mL) Interval -17.9 to 33.6
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Month 21, n=26, 30	-2.1 Nanograms per milliliter (ng/mL) Interval -12.7 to 2.4	-1.8 Nanograms per milliliter (ng/mL) Interval -17.9 to 7.0
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Month 42, n=26, 30	-0.1 Nanograms per milliliter (ng/mL) Interval -12.7 to 23.6	0.6 Nanograms per milliliter (ng/mL) Interval -18.0 to 13.0

SECONDARY outcome

Timeframe: Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)

Population: ITT Population

Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.

Outcome measures

Measure	Bicalutamide 50 mg/Placebo n=65 Participants Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 Participants Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Number of Participants With Metastatic Disease Months 1-18, n=65, 62	8 participants	5 participants
Number of Participants With Metastatic Disease Months 19-42, n=26, 30	1 participants	1 participants
Number of Participants With Metastatic Disease Overall (Months 1-42), n=65, 62	9 participants	6 participants

Adverse Events

Bicalutamide 50 mg/Placebo

Serious events: 31 serious events

Other events: 48 other events

Deaths: 0 deaths

Bicalutamide 50 mg/Dutasteride 3.5 mg

Serious events: 30 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bicalutamide 50 mg/Placebo n=65 participants at risk Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 participants at risk Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Nervous system disorders Cerebrovascular accident	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Dizziness	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Headache	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Loss of consciousness	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Presyncope	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Syncope	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Parkinson's disease	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Myocardial infarction	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Cardiac failure congestive	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Angina pectoris	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Cardiac arrest	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Cardio-respiratory arrest	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Cardiac disorders Supraventricular tachycardia	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Pneumonia	4.6% 3/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Cellulitis	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Lobar pneumonia	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Urinary tract infection	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Orchitis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Urosepsis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Streptococcal bacteraemia	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Sepsis syndrome	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Renal failure	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Urinary retention	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Haematuria	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Renal failure acute	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Renal failure chronic	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Postrenal failure	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Urethral stenosis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Bladder outlet obstruction	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Rib fracture	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Heat stroke	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Subdural haematoma	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Injury, poisoning and procedural complications Postoperative ileus	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Faecaloma	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Colitis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Hiatus hernia	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Refractory anaemia with an excess of blasts	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant lymphoid neoplasm	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Psychiatric disorders Mental status changes	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Psychiatric disorders Completed suicide	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Psychiatric disorders Confusional state	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Aortic aneurysm	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Lymphoedema	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Peripheral vascular disorder	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Peripheral artery aneurysm	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Non-cardiac chest pain	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Chest pain	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Oedema peripheral	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Metabolism and nutrition disorders Decreased appetite	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Blood and lymphatic system disorders Anaemia	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Hepatobiliary disorders Cholecystitis acute	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Investigations Blood pressure increased	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.

Other adverse events

Measure	Bicalutamide 50 mg/Placebo n=65 participants at risk Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).	Bicalutamide 50 mg/Dutasteride 3.5 mg n=62 participants at risk Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
Infections and infestations Urinary tract infection	12.3% 8/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	16.1% 10/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Oedema peripheral	12.3% 8/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	14.5% 9/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Dizziness	13.8% 9/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	11.3% 7/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Constipation	12.3% 8/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	9.7% 6/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Blood and lymphatic system disorders Anaemia	10.8% 7/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	9.7% 6/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Diarrhoea	12.3% 8/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	8.1% 5/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Nasopharyngitis	10.8% 7/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	9.7% 6/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Fatigue	10.8% 7/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	8.1% 5/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Hot flush	13.8% 9/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	4.8% 3/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
General disorders Asthenia	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	8.1% 5/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	8.1% 5/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Back pain	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	12.9% 8/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Upper respiratory tract infection	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	4.8% 3/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Nausea	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	6.5% 4/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Nervous system disorders Headache	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Vascular disorders Hypertension	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Sinusitis	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	4.8% 3/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Urinary retention	7.7% 5/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.6% 3/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	6.5% 4/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Gastrointestinal disorders Vomiting	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	8.1% 5/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Haematuria	9.2% 6/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Pollakiuria	3.1% 2/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	6.5% 4/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Urinary incontinence	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Reproductive system and breast disorders Breast tenderness	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	3.2% 2/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Infections and infestations Ear infection	6.2% 4/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	1.6% 1/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Renal and urinary disorders Nocturia	7.7% 5/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	0.00% 0/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.
Reproductive system and breast disorders Nipple pain	1.5% 1/65 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.	6.5% 4/62 • Serious adverse events (SAEs)/non-serious AEs were collected from the first dose of investigational product to the follow-up (FU) period (16 weeks after end of study treatment) (up to approximately Study Month 46 [42 months of treatment+16 weeks of FU]). SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to study treatment.

Additional Information

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• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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