Trial Outcomes & Findings for Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630) (NCT NCT03833167)

NCT ID: NCT03833167

Last Updated: 2025-12-24

Results Overview

RFS as assessed by investigator was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first. Participants were analyzed in the treatment group to which they were randomized. RFS as assessed by investigator is presented.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: Up to approximately 62 months
• Results posted on: 2025-12-24

Participant Flow

Of the 450 participants randomized, 448 received study intervention.

Participant milestones

Measure	Pembrolizumab Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Overall Study STARTED	225	225
Overall Study Treated	224	224
Overall Study Switchover to Pembrolizumab	0	30
Overall Study Retreatment With Pembrolizumab	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	225	225

Reasons for withdrawal

Measure	Pembrolizumab Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Overall Study Withdrawal by Subject	4	6
Overall Study Ongoing	186	194
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	0	2
Overall Study Death	34	22

Baseline Characteristics

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Baseline characteristics by cohort

Measure	Pembrolizumab n=225 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=225 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.	Total n=450 Participants Total of all reporting groups
Age, Continuous	70.3 Years STANDARD_DEVIATION 10.8 • n=30 Participants	69.2 Years STANDARD_DEVIATION 10.7 • n=30 Participants	69.7 Years STANDARD_DEVIATION 10.7 • n=60 Participants
Sex: Female, Male Female	41 Participants n=30 Participants	41 Participants n=30 Participants	82 Participants n=60 Participants
Sex: Female, Male Male	184 Participants n=30 Participants	184 Participants n=30 Participants	368 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=30 Participants	47 Participants n=30 Participants	93 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=30 Participants	148 Participants n=30 Participants	288 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=30 Participants	30 Participants n=30 Participants	69 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=30 Participants	2 Participants n=30 Participants	4 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	2 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) White	174 Participants n=30 Participants	181 Participants n=30 Participants	355 Participants n=60 Participants
Race (NIH/OMB) More than one race	14 Participants n=30 Participants	11 Participants n=30 Participants	25 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants n=30 Participants	28 Participants n=30 Participants	63 Participants n=60 Participants
Extracapsular Extension Yes	89 Participants n=30 Participants	98 Participants n=30 Participants	187 Participants n=60 Participants
Extracapsular Extension No	135 Participants n=30 Participants	127 Participants n=30 Participants	262 Participants n=60 Participants
Extracapsular Extension Missing Data	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Cortical Bone Invasion Yes	21 Participants n=30 Participants	19 Participants n=30 Participants	40 Participants n=60 Participants
Cortical Bone Invasion No	203 Participants n=30 Participants	206 Participants n=30 Participants	409 Participants n=60 Participants
Cortical Bone Invasion Missing	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Prior Systemic Therapy Yes	16 Participants n=30 Participants	17 Participants n=30 Participants	33 Participants n=60 Participants
Prior Systemic Therapy No	209 Participants n=30 Participants	208 Participants n=30 Participants	417 Participants n=60 Participants

PRIMARY outcome

Timeframe: Up to approximately 62 months

Population: All randomized participants

RFS as assessed by investigator was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first. Participants were analyzed in the treatment group to which they were randomized. RFS as assessed by investigator is presented.

Outcome measures

Measure	Pembrolizumab n=225 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=225 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy	53.3 Months Interval 51.3 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	53.7 Months Interval 51.8 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 62 months

Population: All randomized participants

OS is the time from randomization to death due to any cause. Participants were analyzed in the treatment group to which they were randomized. OS is presented.

Outcome measures

Measure	Pembrolizumab n=225 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=225 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Overall Survival (OS)	NA Months NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and up to approximately 60 months

Population: All participants who had at least one dose of study intervention and one EORTC QLQ-C30 score available

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.

Outcome measures

Measure	Pembrolizumab n=223 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score	-7.05 Score on scale Interval -10.91 to -3.19	-3.64 Score on scale Interval -7.74 to 0.47

SECONDARY outcome

Timeframe: Baseline and up to approximately 60 months

Population: All participants who had at least one dose of study intervention and one EORTC QLQ-C30 score available

Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function. Participants were analyzed in the treatment group to which they were randomized. Change from baseline in EORTC QLQ-C30 physical functioning is presented.

Outcome measures

Measure	Pembrolizumab n=223 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score	-7.60 Scores on a scale Interval -10.56 to -4.63	-4.71 Scores on a scale Interval -7.83 to -1.59

SECONDARY outcome

Timeframe: Up to approximately 62 months

Population: All randomized participants who received at least one dose of study treatment

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE is presented.

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Percentage of Participants Who Experience an Adverse Event (AE)	94.2 Percentage of participants	88.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 19 months

Population: All randomized participants who received at least one dose of study treatment

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE is presented.

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 Participants Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	10.3 Percentage of participants	4.0 Percentage of participants

Adverse Events

Pembrolizumab

Serious events: 55 serious events

Other events: 175 other events

Deaths: 34 deaths

Placebo

Serious events: 43 serious events

Other events: 143 other events

Deaths: 14 deaths

Pembrolizumab (Retreatment Phase)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Placebo Crossover

Serious events: 15 serious events

Other events: 23 other events

Deaths: 10 deaths

Serious adverse events

Measure	Pembrolizumab n=224 participants at risk Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 participants at risk Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.	Pembrolizumab (Retreatment Phase) n=2 participants at risk Participants who received 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles and experience biopsy-proven-disease recurrence received up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo Crossover n=30 participants at risk Participants who received placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab 400 mg by IV infusion administered on Day 1 of each 42-day cycle (Q6W) in an open-label design.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Acute myocardial infarction	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Coronary artery disease	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocardial infarction	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocardial ischaemia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocarditis	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Pericarditis	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Ear and labyrinth disorders Vertigo positional	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Adrenal insufficiency	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Lagophthalmos	0.45% 1/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Colitis microscopic	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Melaena	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Umbilical hernia	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Asthenia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholecystitis	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholecystitis acute	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.45% 1/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Brain abscess	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19 pneumonia	1.3% 3/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Cellulitis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Dengue fever	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Erysipelas	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Herpes zoster	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Infected seroma	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Influenza	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Lower respiratory tract infection	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Mastoiditis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pneumonia	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pneumonia bacterial	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Sepsis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Septic shock	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Skin infection	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Soft tissue infection	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection	0.89% 2/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urosepsis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Viral infection	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Head injury	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Lower limb fracture	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Patella fracture	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood sodium decreased	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Dehydration	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypercalcaemia	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypoglycaemia	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Joint lock	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myositis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	8.0% 18/224 • Number of events 27 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.0% 18/224 • Number of events 44 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Guillain-Barre syndrome	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant fibrous histiocytoma	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Ischaemic stroke	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Metabolic encephalopathy	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Neuralgia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Presyncope	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Completed suicide	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Delirium	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Acute kidney injury	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Nephrolithiasis	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Ureterolithiasis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Urinary retention	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin ulcer	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Deep vein thrombosis	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypovolaemic shock	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Other adverse events

Measure	Pembrolizumab n=224 participants at risk Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo n=224 participants at risk Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.	Pembrolizumab (Retreatment Phase) n=2 participants at risk Participants who received 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles and experience biopsy-proven-disease recurrence received up to 18 additional cycles of pembrolizumab in an open-label design.	Placebo Crossover n=30 participants at risk Participants who received placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab 400 mg by IV infusion administered on Day 1 of each 42-day cycle (Q6W) in an open-label design.
Endocrine disorders Hyperthyroidism	5.4% 12/224 • Number of events 13 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	11.6% 26/224 • Number of events 26 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.4% 12/224 • Number of events 14 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Lacrimation increased	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	7.1% 16/224 • Number of events 18 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.5% 19/224 • Number of events 20 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	12.5% 28/224 • Number of events 41 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	12.5% 28/224 • Number of events 33 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dry mouth	6.2% 14/224 • Number of events 14 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.0% 9/224 • Number of events 9 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Inguinal hernia	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	4.9% 11/224 • Number of events 14 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.4% 12/224 • Number of events 13 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Asthenia	12.5% 28/224 • Number of events 33 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.0% 18/224 • Number of events 19 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Fatigue	17.0% 38/224 • Number of events 41 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.4% 30/224 • Number of events 31 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 4 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Influenza like illness	3.1% 7/224 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.8% 4/224 • Number of events 8 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Oedema peripheral	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.9% 11/224 • Number of events 11 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 4/30 • Number of events 4 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Influenza	1.8% 4/224 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.3% 3/224 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Fall	2.7% 6/224 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 4 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Skin abrasion	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	5.4% 12/224 • Number of events 12 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.6% 8/224 • Number of events 9 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations SARS-CoV-2 test positive	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Weight decreased	4.9% 11/224 • Number of events 11 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.5% 10/224 • Number of events 10 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	3.1% 7/224 • Number of events 8 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.2% 5/224 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	11.2% 25/224 • Number of events 32 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.9% 20/224 • Number of events 23 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	5.8% 13/224 • Number of events 14 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.6% 8/224 • Number of events 9 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 9/224 • Number of events 10 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.2% 5/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	4.0% 9/224 • Number of events 12 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.0% 18/224 • Number of events 40 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/30 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	3.1% 7/224 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.8% 4/224 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	6.7% 15/224 • Number of events 24 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.6% 17/224 • Number of events 19 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dizziness	4.0% 9/224 • Number of events 9 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.0% 9/224 • Number of events 11 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dysgeusia	2.2% 5/224 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.89% 2/224 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Headache	8.5% 19/224 • Number of events 21 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.1% 16/224 • Number of events 17 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Paraesthesia	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.3% 3/224 • Number of events 4 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Depressed mood	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/224 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 15/224 • Number of events 15 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.1% 7/224 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.7% 6/224 • Number of events 6 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.45% 1/224 • Number of events 1 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Actinic keratosis	8.5% 19/224 • Number of events 24 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	12.1% 27/224 • Number of events 40 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Pruritus	18.8% 42/224 • Number of events 50 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.0% 18/224 • Number of events 20 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	16.7% 5/30 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	8.9% 20/224 • Number of events 26 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.6% 17/224 • Number of events 17 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.4% 12/224 • Number of events 13 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.2% 5/224 • Number of events 5 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 3/30 • Number of events 7 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin lesion	1.3% 3/224 • Number of events 15 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.4% 12/224 • Number of events 19 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 2/30 • Number of events 4 • All-cause mortality and adverse events up to approximately 62 months. All-cause mortality included all randomized participants. Serious and other adverse events included all participants who received at least one dose of study intervention. For all-cause mortality participants were followed until they switched groups, then were followed in the crossover group. MedDRA Version: 27.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
• Publication restrictions are in place

Restriction type: OTHER