Trial Outcomes & Findings for Effect of LY450139 on the Long Term Progression of Alzheimer's Disease (NCT NCT00594568)

Last Updated: 2015-03-17

Results Overview

ADAS-Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1537 participants

Primary outcome timeframe

Baseline (randomization), 76 weeks

Results posted on

2015-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Initial Treatment STARTED	501	507	529
Initial Treatment Intent-to-treat (ITT)	501	506	527
Initial Treatment COMPLETED	189	153	121
Initial Treatment NOT COMPLETED	312	354	408
Delayed Start STARTED	189	153	121
Delayed Start COMPLETED	91	76	55
Delayed Start NOT COMPLETED	98	77	66
Safety Follow Up (SFU)-Optional STARTED	290	223	214
Safety Follow Up (SFU)-Optional COMPLETED	229	168	172
Safety Follow Up (SFU)-Optional NOT COMPLETED	61	55	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Initial Treatment Adverse Event	51	121	144
Initial Treatment Death	6	11	15
Initial Treatment Lost to Follow-up	4	1	4
Initial Treatment Physician Decision	3	2	4
Initial Treatment Protocol Violation	2	2	5
Initial Treatment Withdrawal by Subject	25	31	46
Initial Treatment Sponsor decision	193	142	147
Initial Treatment Caregiver decision	21	36	36
Initial Treatment Abnormal lab/electrocardiogram (ECG)	7	7	6
Initial Treatment Entry criteria exclusion	0	1	1
Delayed Start Death	0	0	1
Delayed Start Adverse Event	12	2	2
Delayed Start Withdrawal by Subject	4	3	0
Delayed Start Physician Decision	0	0	1
Delayed Start Lost to Follow-up	0	0	1
Delayed Start Caregiver Decision	5	6	2
Delayed Start Sponsor Decision	77	66	59
Safety Follow Up (SFU)-Optional Death	0	1	0
Safety Follow Up (SFU)-Optional Adverse Event	5	0	0
Safety Follow Up (SFU)-Optional Withdrawal by Subject	12	15	13
Safety Follow Up (SFU)-Optional Lost to Follow-up	2	1	2
Safety Follow Up (SFU)-Optional Caregiver Decision	17	16	9
Safety Follow Up (SFU)-Optional No safety visit or follow up	25	22	18

Baseline Characteristics

Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=501 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=506 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=527 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.	Total n=1534 Participants Total of all reporting groups
Age, Continuous	73.9 years STANDARD_DEVIATION 8.1 • n=5 Participants	73.6 years STANDARD_DEVIATION 8.0 • n=7 Participants	73.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	73.8 years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	278 Participants n=5 Participants	279 Participants n=7 Participants	263 Participants n=5 Participants	820 Participants n=4 Participants
Sex: Female, Male Male	223 Participants n=5 Participants	227 Participants n=7 Participants	264 Participants n=5 Participants	714 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	413 participants n=5 Participants	428 participants n=7 Participants	441 participants n=5 Participants	1282 participants n=4 Participants
Race/Ethnicity, Customized African	3 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	12 participants n=4 Participants
Race/Ethnicity, Customized Hispanic	33 participants n=5 Participants	22 participants n=7 Participants	24 participants n=5 Participants	79 participants n=4 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized East Asian	47 participants n=5 Participants	45 participants n=7 Participants	51 participants n=5 Participants	143 participants n=4 Participants
Race/Ethnicity, Customized West Asian	5 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	16 participants n=4 Participants
Region of Enrollment United States	192 participants n=5 Participants	194 participants n=7 Participants	199 participants n=5 Participants	585 participants n=4 Participants
Region of Enrollment Finland	6 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	22 participants n=4 Participants
Region of Enrollment Spain	24 participants n=5 Participants	24 participants n=7 Participants	25 participants n=5 Participants	73 participants n=4 Participants
Region of Enrollment Chile	17 participants n=5 Participants	14 participants n=7 Participants	12 participants n=5 Participants	43 participants n=4 Participants
Region of Enrollment Israel	22 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	64 participants n=4 Participants
Region of Enrollment Italy	6 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	17 participants n=4 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants	20 participants n=7 Participants	21 participants n=5 Participants	55 participants n=4 Participants
Region of Enrollment India	10 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	30 participants n=4 Participants
Region of Enrollment France	15 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	43 participants n=4 Participants
Region of Enrollment Canada	20 participants n=5 Participants	21 participants n=7 Participants	18 participants n=5 Participants	59 participants n=4 Participants
Region of Enrollment Argentina	24 participants n=5 Participants	23 participants n=7 Participants	26 participants n=5 Participants	73 participants n=4 Participants
Region of Enrollment Poland	12 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants	45 participants n=4 Participants
Region of Enrollment Belgium	8 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	18 participants n=4 Participants
Region of Enrollment Australia	20 participants n=5 Participants	25 participants n=7 Participants	24 participants n=5 Participants	69 participants n=4 Participants
Region of Enrollment Denmark	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment South Africa	26 participants n=5 Participants	28 participants n=7 Participants	30 participants n=5 Participants	84 participants n=4 Participants
Region of Enrollment Germany	29 participants n=5 Participants	21 participants n=7 Participants	27 participants n=5 Participants	77 participants n=4 Participants
Region of Enrollment Japan	41 participants n=5 Participants	37 participants n=7 Participants	43 participants n=5 Participants	121 participants n=4 Participants
Region of Enrollment Sweden	10 participants n=5 Participants	17 participants n=7 Participants	15 participants n=5 Participants	42 participants n=4 Participants
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) Score	22.8 units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants	22.5 units on a scale STANDARD_DEVIATION 8.9 • n=7 Participants	23.1 units on a scale STANDARD_DEVIATION 8.8 • n=5 Participants	22.8 units on a scale STANDARD_DEVIATION 8.9 • n=4 Participants
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score	60.5 units on a scale STANDARD_DEVIATION 13.0 • n=5 Participants	62.3 units on a scale STANDARD_DEVIATION 11.6 • n=7 Participants	60.5 units on a scale STANDARD_DEVIATION 12.4 • n=5 Participants	61.1 units on a scale STANDARD_DEVIATION 12.4 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Outcome measures

Outcome measures
Measure	Placebo n=270 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=216 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=199 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks	6.19 units on a scale Standard Error 0.54	7.29 units on a scale Standard Error 0.57	7.68 units on a scale Standard Error 0.59

PRIMARY outcome

Timeframe: Baseline (randomization), 16 weeks following treatment cessation

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=154 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=146 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug	6.59 units on a scale Standard Error 0.80	7.57 units on a scale Standard Error 0.91	7.90 units on a scale Standard Error 0.90

PRIMARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=266 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=216 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=197 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks	-8.76 units on a scale Standard Error 0.72	-10.13 units on a scale Standard Error 0.77	-12.70 units on a scale Standard Error 0.79

PRIMARY outcome

Timeframe: Baseline (randomization), 16 weeks following treatment cessation

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Outcome measures

Outcome measures
Measure	Placebo n=198 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=153 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=147 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug	-9.26 units on a scale Standard Error 1.14	-9.15 units on a scale Standard Error 1.28	-11.73 units on a scale Standard Error 1.26

SECONDARY outcome

Timeframe: Baseline (randomization), 52 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=265 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=245 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks	3.86 picogram per milliliter (pg/mL) Standard Error 2.32	-5.97 picogram per milliliter (pg/mL) Standard Error 2.50	-19.95 picogram per milliliter (pg/mL) Standard Error 2.58

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=42 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=43 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks	-0.08 ratio Standard Error 0.01	-0.12 ratio Standard Error 0.01	-0.11 ratio Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=69 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=64 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks Left Hippocampal Volume	-96.54 cubic millimeter (mm^3) Standard Error 10.73	-75.34 cubic millimeter (mm^3) Standard Error 11.06	-107.62 cubic millimeter (mm^3) Standard Error 11.38
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks Right Hippocampal Volume	-108.69 cubic millimeter (mm^3) Standard Error 11.56	-93.89 cubic millimeter (mm^3) Standard Error 12.19	-112.40 cubic millimeter (mm^3) Standard Error 12.52

SECONDARY outcome

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=23 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=18 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks	0.08 ratio Standard Error 0.06	0.06 ratio Standard Error 0.06	0.09 ratio Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=17 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=18 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks	75.11 picogram per milliliter (pg/mL) Standard Error 92.02	20.50 picogram per milliliter (pg/mL) Standard Error 69.54	61.00 picogram per milliliter (pg/mL) Standard Error 59.07

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and 52 weeks

Population: The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.

Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.

Outcome measures

Outcome measures
Measure	Placebo n=974 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
LY450139 Population Pharmacokinetics: Clearance of LY450139	18.8 liter per hour (L/h) Geometric Coefficient of Variation 26.8	—	—

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and 52 weeks

Population: The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.

Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.

Outcome measures

Outcome measures
Measure	Placebo n=974 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139	66.8 liter (L) Geometric Coefficient of Variation 26.1	—	—

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=269 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=215 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=199 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks	6.52 units on a scale Standard Error 0.58	7.98 units on a scale Standard Error 0.61	8.33 units on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=270 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=216 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=198 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks	7.42 units on a scale Standard Error 0.63	8.97 units on a scale Standard Error 0.67	9.48 units on a scale Standard Error 0.69

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=376 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=289 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=274 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks	-2.95 units on a scale Standard Error 0.26	-3.14 units on a scale Standard Error 0.27	-3.71 units on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=267 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=216 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=195 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks	2.31 units on a scale Standard Error 0.17	2.73 units on a scale Standard Error 0.18	3.04 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=369 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=298 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=271 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks	1.92 units on a scale Standard Error 0.75	3.31 units on a scale Standard Error 0.79	4.15 units on a scale Standard Error 0.81

SECONDARY outcome

Timeframe: Baseline (randomization), 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.

Outcome measures

Outcome measures
Measure	Placebo n=374 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=300 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=275 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks	-1.41 units on a scale Standard Error 1.11	-7.49 units on a scale Standard Error 1.20	-5.33 units on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=98 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=94 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks	0.55 hospitalizations/participant Standard Error 0.09	0.66 hospitalizations/participant Standard Error 0.07	0.83 hospitalizations/participant Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline (randomization), 16 weeks following treatment cessation

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=154 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=146 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug	6.97 units on a scale Standard Error 0.84	8.27 units on a scale Standard Error 0.95	8.41 units on a scale Standard Error 0.94

SECONDARY outcome

Timeframe: Baseline (randomization), 16 weeks following treatment cessation

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=153 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=146 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug	7.90 units on a scale Standard Error 0.93	9.30 units on a scale Standard Error 1.06	9.89 units on a scale Standard Error 1.04

SECONDARY outcome

Timeframe: Baseline (randomization), 4 weeks following treatment cessation

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=19 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=18 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks	-86.16 picogram per milliliter (pg/mL) Standard Error 50.89	23.27 picogram per milliliter (pg/mL) Standard Error 34.55	-40.51 picogram per milliliter (pg/mL) Standard Error 31.68

SECONDARY outcome

Timeframe: Baseline (randomization), up to 76 weeks

Population: The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.

Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 n=19 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 n=18 Participants Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid	9.75 picogram per milliliter (pg/mL) Standard Error 7.67	-6.26 picogram per milliliter (pg/mL) Standard Error 5.46	-5.13 picogram per milliliter (pg/mL) Standard Error 5.04

Deaths: 0 deaths

140 mg LY450139- SFU

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Initial Treatment Period (NT) n=501 participants at risk Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.	100 mg LY450139 - NT n=507 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 - NT n=529 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.	Placebo - Delayed Start Period (DO) n=192 participants at risk Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 - DO n=153 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 - DO n=124 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.	Placebo- Safety FU Period (SFU) n=290 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.	100 mg LY450139- SFU n=223 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.	140 mg LY450139- SFU n=214 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
Infections and infestations Pneumonia bacterial	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Cholecystitis infective	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Device related infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Diverticulitis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Epiglottitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Bronchitis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Bronchopneumonia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Candidiasis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Cellulitis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Clostridial infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Clostridium difficile colitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Cystitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Gastric infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Gastroenteritis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Herpes zoster	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Infection	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Lobar pneumonia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Lower respiratory tract infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Necrotising fasciitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Osteomyelitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pneumonia	1.2% 6/501 • Number of events 6 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	2.8% 14/507 • Number of events 14 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.1% 6/529 • Number of events 8 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pneumonia haemophilus	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pneumonia legionella	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pseudomembranous colitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pyelonephritis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pyelonephritis acute	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Pyometra	0.00% 0/278 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/280 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 1/263 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/114 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/85 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/61 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/168 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Renal cyst infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Respiratory tract infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Salmonellosis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Sepsis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Septic shock	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Sinobronchitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Sinusitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Staphylococcal skin infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Upper respiratory tract infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Urinary tract infection	0.60% 3/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.79% 4/507 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.95% 5/529 • Number of events 5 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Urosepsis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Viral infection	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Wound infection staphylococcal	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Animal bite	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Ankle fracture	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Contusion	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Fall	1.00% 5/501 • Number of events 5 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.79% 4/507 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.3% 7/529 • Number of events 7 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.90% 2/223 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Femoral neck fracture	0.60% 3/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Femur fracture	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Head injury	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Hip fracture	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Meniscus lesion	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Skin laceration	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Subdural haematoma	0.40% 2/501 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Investigations Gamma-glutamyltransferase increased	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Investigations Hepatic enzyme increased	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Investigations Weight decreased	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Dehydration	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.95% 5/529 • Number of events 5 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Starvation	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Intestinal obstruction	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Bone pain	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Costochondritis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Chest pain	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Hepatobiliary disorders Cholecystitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Blood and lymphatic system disorders Anaemia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Acute myocardial infarction	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Angina pectoris	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Aortic valve incompetence	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Arrhythmia	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Arteriosclerosis coronary artery	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Atrial fibrillation	0.60% 3/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Atrioventricular block	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Atrioventricular block complete	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Bradycardia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.59% 3/507 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Cardiac failure congestive	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Myocardial infarction	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Myocardial ischaemia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Nodal rhythm	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Pleuropericarditis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Sick sinus syndrome	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Sinus bradycardia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Supraventricular tachycardia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Cardiac disorders Torsade de pointes	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Eye disorders Cataract	0.40% 2/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Eye disorders Glaucoma	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Abdominal pain	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Colitis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Colonic polyp	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Diarrhoea	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Dysphagia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Haematochezia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Haemorrhoids	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Ileus	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Hepatobiliary disorders Hepatic steatosis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Ileus paralytic	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Inguinal hernia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Inguinal hernia strangulated	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Nausea	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Oesophageal rupture	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Pancreatitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Umbilical hernia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Volvulus	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Vomiting	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Asthenia	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Death	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Device dislocation	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Gait disturbance	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Non-cardiac chest pain	0.60% 3/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.59% 3/507 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Oedema peripheral	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Sudden death	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Hepatobiliary disorders Cholecystitis acute	0.20% 1/501 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Hepatobiliary disorders Cholelithiasis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Immune system disorders Hypersensitivity	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Abscess oral	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Appendicitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Calculus ureteric	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Cystitis glandularis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Eosinophilic cystitis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Renal failure	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Renal failure acute	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Renal injury	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Urethral caruncle	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Urethral stenosis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.88% 2/227 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 1/266 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/78 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.5% 1/68 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/63 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/122 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/99 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/227 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 1/266 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/78 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/68 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/63 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/122 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/99 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Social circumstances Immobile	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Aortic aneurysm rupture	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Deep vein thrombosis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Embolism venous	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Hypertension	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Hypertensive crisis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Hypotension	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Orthostatic hypotension	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Phlebitis	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Varicose vein	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Vascular disorders Venous insufficiency	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.40% 2/501 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.79% 4/507 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.3% 3/223 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage iv	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gingival cancer	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.79% 4/507 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage i	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.00% 0/278 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.36% 1/280 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/263 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/114 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/85 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/61 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/168 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage iv	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/227 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 1/266 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/78 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/68 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/63 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/122 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.0% 1/99 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/227 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 1/266 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/78 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/68 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/63 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/122 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/99 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.59% 3/507 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.76% 4/529 • Number of events 5 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/278 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/280 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/263 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.88% 1/114 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/85 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/61 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/168 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/278 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.36% 1/280 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/263 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/114 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/85 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/61 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/168 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/107 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Syncope	0.40% 2/501 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.4% 7/507 • Number of events 7 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	1.1% 6/529 • Number of events 6 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.65% 1/153 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Ataxia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Brain stem stroke	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Haemorrhage intracranial	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Cerebral haemorrhage	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Cerebrovascular accident	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Dementia alzheimer's type	0.60% 3/501 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Depressed level of consciousness	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Dizziness	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Encephalopathy	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Epilepsy	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Grand mal convulsion	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Haemorrhagic stroke	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.39% 2/507 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.34% 1/290 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Hypertensive encephalopathy	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Ischaemic cerebral infarction	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Ischaemic stroke	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.76% 4/529 • Number of events 4 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Thalamus haemorrhage	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Migraine	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.81% 1/124 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Presyncope	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.57% 3/529 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Psychomotor skills impaired	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.52% 1/192 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Mental disorder	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Subarachnoid haemorrhage	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Transient ischaemic attack	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Abnormal behaviour	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Aggression	0.40% 2/501 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.38% 2/529 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Agitation	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.59% 3/507 • Number of events 3 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Behavioural and psychiatric symptoms of dementia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.90% 2/223 • Number of events 2 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Confusional state	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Delusion	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Delusional disorder, unspecified type	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Depression	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.47% 1/214 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Hallucination, visual	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Hypomania	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Major depression	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Mental status changes	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.45% 1/223 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Paranoia	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Suicidal ideation	0.20% 1/501 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Bladder disorder	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.20% 1/507 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/529 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/501 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/507 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.19% 1/529 • Number of events 1 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.

Other adverse events

Other adverse events
Measure	Placebo - Initial Treatment Period (NT) n=501 participants at risk Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.	100 mg LY450139 - NT n=507 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 - NT n=529 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.	Placebo - Delayed Start Period (DO) n=192 participants at risk Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.	100 mg LY450139 - DO n=153 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.	140 mg LY450139 - DO n=124 participants at risk Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.	Placebo- Safety FU Period (SFU) n=290 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.	100 mg LY450139- SFU n=223 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.	140 mg LY450139- SFU n=214 participants at risk For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
Gastrointestinal disorders Diarrhoea	10.8% 54/501 • Number of events 93 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	10.7% 54/507 • Number of events 67 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	13.4% 71/529 • Number of events 87 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Nausea	4.6% 23/501 • Number of events 27 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	10.1% 51/507 • Number of events 69 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	11.9% 63/529 • Number of events 71 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Gastrointestinal disorders Vomiting	3.6% 18/501 • Number of events 21 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	8.7% 44/507 • Number of events 50 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	8.3% 44/529 • Number of events 67 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
General disorders Fatigue	6.0% 30/501 • Number of events 32 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.7% 24/507 • Number of events 25 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.9% 31/529 • Number of events 36 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Nasopharyngitis	6.6% 33/501 • Number of events 40 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.7% 24/507 • Number of events 26 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.9% 31/529 • Number of events 33 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Upper respiratory tract infection	3.8% 19/501 • Number of events 20 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.3% 27/507 • Number of events 33 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.9% 31/529 • Number of events 39 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Infections and infestations Urinary tract infection	5.8% 29/501 • Number of events 39 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.1% 31/507 • Number of events 44 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	7.4% 39/529 • Number of events 44 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Injury, poisoning and procedural complications Fall	8.0% 40/501 • Number of events 50 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	7.1% 36/507 • Number of events 45 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.2% 33/529 • Number of events 37 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Investigations Weight decreased	2.6% 13/501 • Number of events 14 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.9% 25/507 • Number of events 25 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	8.9% 47/529 • Number of events 48 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Metabolism and nutrition disorders Decreased appetite	3.2% 16/501 • Number of events 16 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	7.1% 36/507 • Number of events 37 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	10.6% 56/529 • Number of events 61 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Dizziness	4.2% 21/501 • Number of events 21 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.3% 32/507 • Number of events 41 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.3% 28/529 • Number of events 30 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Nervous system disorders Headache	7.0% 35/501 • Number of events 46 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.5% 33/507 • Number of events 42 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	7.8% 41/529 • Number of events 57 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Agitation	4.4% 22/501 • Number of events 23 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.3% 27/507 • Number of events 27 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.7% 25/529 • Number of events 27 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Depression	3.0% 15/501 • Number of events 15 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.5% 23/507 • Number of events 23 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.6% 35/529 • Number of events 36 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Psychiatric disorders Insomnia	3.8% 19/501 • Number of events 21 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.1% 26/507 • Number of events 28 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.2% 22/529 • Number of events 22 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 19/501 • Number of events 22 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.7% 29/507 • Number of events 36 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	6.6% 35/529 • Number of events 36 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Hair colour changes	1.4% 7/501 • Number of events 8 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	12.4% 63/507 • Number of events 64 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	18.7% 99/529 • Number of events 106 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Rash erythematous	1.8% 9/501 • Number of events 10 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	4.5% 23/507 • Number of events 25 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.3% 28/529 • Number of events 38 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Rash macular	3.4% 17/501 • Number of events 20 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	7.1% 36/507 • Number of events 43 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	8.1% 43/529 • Number of events 50 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 7/501 • Number of events 8 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	3.2% 16/507 • Number of events 17 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	5.1% 27/529 • Number of events 28 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/192 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/153 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/124 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/290 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/223 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.	0.00% 0/214 Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60