Trial Outcomes & Findings for Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine (NCT NCT00584844)

NCT ID: NCT00584844

Last Updated: 2020-01-02

Results Overview

AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 484 participants
• Primary outcome timeframe: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year
• Results posted on: 2020-01-02

Participant Flow

Enrollment at the Special Immunizations Clinic at USAMRIID is expected to last 5 years and include up to 1,000 subjects who were at risk of occupational exposure to F tularensis.

Participant milestones

Measure	F Tularensis Vaccine (0.0025 mL) Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine. Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (\< 1:20).
Overall Study STARTED	484
Overall Study COMPLETED	405
Overall Study NOT COMPLETED	79

Reasons for withdrawal

Measure	F Tularensis Vaccine (0.0025 mL) Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine. Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (\< 1:20).
Overall Study Withdrawal by Subject	59
Overall Study Screen Failure	20

Baseline Characteristics

Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

Baseline characteristics by cohort

Measure	F Tularensis Vaccine (0.0025 mL) n=405 Participants Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine. Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (\< 1:20).
Age, Customized <20 years	2 Participants n=5 Participants
Age, Customized 20-29 years	108 Participants n=5 Participants
Age, Customized 30-39 years	126 Participants n=5 Participants
Age, Customized 40-49 years	106 Participants n=5 Participants
Age, Customized 50-59 years	54 Participants n=5 Participants
Age, Customized 60-69 years	9 Participants n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants
Sex: Female, Male Male	260 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	382 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	357 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	405 participants n=5 Participants

PRIMARY outcome

Timeframe: AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year

AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.

Outcome measures

Measure	Males n=294 Participants All males in study	Females n=168 Participants All females in study
Safety: Adverse Event Category Rates for All Vaccinations Systemic: Severe	11 Adverse events	9 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Relationship: Unrelated	30 Adverse events	28 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Any AE: Mild	264 Adverse events	162 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Any AE: Moderate	53 Adverse events	48 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Any AE: Severe	11 Adverse events	10 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Local: Mild	248 Adverse events	153 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Local: Moderate	7 Adverse events	13 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Locale: Severe	0 Adverse events	1 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Systemic: Mild	121 Adverse events	105 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Systemic: Moderate	48 Adverse events	42 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Relationship: Unlikely	33 Adverse events	29 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Relationship: Possible	86 Adverse events	77 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Relationship: Probable	62 Adverse events	41 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Relationship: Definate	246 Adverse events	153 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Outcome: Resolved	271 Adverse events	163 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Outcome: Resolved with sequelae	4 Adverse events	1 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Treatment required:None	260 Adverse events	160 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Treatment required: Intervention required	75 Adverse events	75 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Treatment required: Other	7 Adverse events	1 Adverse events
Safety: Adverse Event Category Rates for All Vaccinations Treatment required: Hospitalization	6 Adverse events	6 Adverse events

SECONDARY outcome

Timeframe: 12 months

Population: As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 454 were compliant and analyzed.

Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.

Outcome measures

Measure	Males n=454 Participants All males in study	Females All females in study
Immunogenicity: Protocol Compliant Post-primary Titer Rates Days 28-35: All subjects <1.20	4.1 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Days 28-35: All subjects >1.20	95.9 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Days 56-84: All subjects <1.20	73.3 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Days 56-84: All subjects >1:20	26.7 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Month 12: All subjects <1:20	3.6 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Month 12: All subjects >1:20	96.4 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Overall: <1:20	2.6 Percentage of subjects	—
Immunogenicity: Protocol Compliant Post-primary Titer Rates Overall: >1:20	97.4 Percentage of subjects	—

SECONDARY outcome

Timeframe: 12 months

Population: As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 19 were compliant and analyzed.

Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1

Outcome measures

Measure	Males n=19 Participants All males in study	Females All females in study
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Days 28-35: <1:20	22.2 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Days 28-35: >1:20	77.8 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Days 56-84: <1:20	100.0 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Days 56-84: >1:20	0 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Month 12: <1:20	43.8 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Month 12: >1:20	56.3 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Overall: <1:20	26.3 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates Overall: >1:20	73.7 Percentage of subjects	—

SECONDARY outcome

Timeframe: 12 months

Population: As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 18 were compliant and analyzed.

Percentage of subjects with less than or greater than titers who received post-boost 2.

Responder = > 1:20 Non-responder = < 1:20

Outcome measures

Measure	Males n=18 Participants All males in study	Females All females in study
Immunogenicity: Protocol-compliant Post-boost 2 Titer Days 28-35: Non-Responder	5.6 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Days 28-35:Responder	94.4 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Days 56-84: Non-Responder	25.0 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Days 56-84: Responder	75.0 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Month 12: Non-Responder	6.3 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Month 12: Responder	93.8 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Overall: Non-Responder	5.3 Percentage of subjects	—
Immunogenicity: Protocol-compliant Post-boost 2 Titer Overall: Responder	94.7 Percentage of subjects	—

Adverse Events

Mild

Serious events: 0 serious events

Other events: 426 other events

Deaths: 0 deaths

Moderate

Serious events: 10 serious events

Other events: 101 other events

Deaths: 0 deaths

Severe

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mild n=462 participants at risk Mild	Moderate n=462 participants at risk Moderate	Severe n=462 participants at risk Severe
Cardiac disorders Myocardial infarction	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Hepatobiliary disorders Cholelithiasis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Malaria	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Pilonidal cyst	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Spondylolysis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Neuropathy peripheral	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Psychiatric disorders Depression	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Menorrhagia	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.

Other adverse events

Measure	Mild n=462 participants at risk Mild	Moderate n=462 participants at risk Moderate	Severe n=462 participants at risk Severe
Blood and lymphatic system disorders Lymph node pain	3.7% 17/462 • Number of events 17 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Blood and lymphatic system disorders Lymphadenopathy	17.1% 79/462 • Number of events 82 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Cardiac disorders Myocardial infarction	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Cardiac disorders Palpitations	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Ear and labyrinth disorders Ear congestion	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Ear and labyrinth disorders Ear pain	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Conjunctivitis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Conjunctivitis allergic	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Eye discharge	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Eye pruritus	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Ocular hyperaemia	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Eye disorders Photophobia	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Abdominal discomfort	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Abdominal pain	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Abdominal pain lower	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Abdominal pain upper	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Aphthous stomatitis	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Constipation	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Diarrhoea	2.2% 10/462 • Number of events 10 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Dry mouth	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Dyspepsia	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Gingival pain	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Nausea	3.9% 18/462 • Number of events 18 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.7% 8/462 • Number of events 8 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Toothache	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Gastrointestinal disorders Vomiting	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Axillary pain	17.1% 79/462 • Number of events 79 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Chest discomfort	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Chills	1.3% 6/462 • Number of events 7 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.1% 5/462 • Number of events 5 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Fatigue	7.8% 36/462 • Number of events 36 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	2.4% 11/462 • Number of events 11 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Feeling hot	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Influenza like illness	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site discharge	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site erythema	76.8% 355/462 • Number of events 370 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.7% 8/462 • Number of events 8 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site exfoliation	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site induration	22.5% 104/462 • Number of events 104 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site oedema	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site pain	17.1% 79/462 • Number of events 79 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site paraesthesia	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site pruritus	24.0% 111/462 • Number of events 111 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site rash	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Injection site vesicles	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Malaise	8.7% 40/462 • Number of events 40 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.9% 9/462 • Number of events 9 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Non-cardiac chest pain	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Oedema peripheral	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Pain	3.0% 14/462 • Number of events 14 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Pyrexia	2.6% 12/462 • Number of events 12 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.7% 8/462 • Number of events 8 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
General disorders Vaccination site pain	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Hepatobiliary disorders Cholelithiasis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Bronchitis	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Conjunctivitis infective	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Eye infection	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Folliculitis	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Gastroenteritis viral	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Hordeolum	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Injection site pustule	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Lower respiratory tract infection	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Lymphangitis	0.87% 4/462 • Number of events 4 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Malaria	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Oral herpes	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Pharyngitis streptococcal	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Pilonidal cyst	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Respiratory tract infection	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Rhinitis	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Sinusitis	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Upper respiratory tract infection	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Urinary tract infection	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Vaginal infection	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Animal bite	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Animal scratch	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Arthropod bite	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Contusion	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Eye injury	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Joint sprain	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Limb crushing injury	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Limb injury	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Muscle strain	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Skin laceration	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Injury, poisoning and procedural complications Vaccination complication	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Investigations Lymph node palpable	4.1% 19/462 • Number of events 19 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Metabolism and nutrition disorders Decreased appetite	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Metabolism and nutrition disorders Gout	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 30/462 • Number of events 34 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.87% 4/462 • Number of events 4 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Back pain	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Muscle spasms	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Muscle tightness	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.7% 17/462 • Number of events 19 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 4 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 23/462 • Number of events 23 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.1% 5/462 • Number of events 5 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Neck pain	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Nodule on extremity	2.2% 10/462 • Number of events 10 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 42/462 • Number of events 43 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.1% 5/462 • Number of events 5 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Pain in jaw	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Musculoskeletal and connective tissue disorders Spondylolysis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Disturbance in attention	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Dizziness	1.5% 7/462 • Number of events 7 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Headache	18.6% 86/462 • Number of events 86 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	5.0% 23/462 • Number of events 23 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Lethargy	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Migraine	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Neuropathy peripheral	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Paraesthesia	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Sinus headache	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Nervous system disorders Tension headache	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Psychiatric disorders Depression	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Psychiatric disorders Insomnia	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Psychiatric disorders Panic attack	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Renal and urinary disorders Bladder discomfort	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Renal and urinary disorders Dysuria	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Dysmenorrhoea	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Menorrhagia	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Prostatitis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 23/462 • Number of events 23 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Dry throat	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.8% 27/462 • Number of events 27 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.1% 5/462 • Number of events 5 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 34/462 • Number of events 34 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.3% 6/462 • Number of events 6 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Sinus congestion	2.8% 13/462 • Number of events 13 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Sneezing	1.1% 5/462 • Number of events 5 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Throat irritation	1.5% 7/462 • Number of events 7 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Dermatitis	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Eczema	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Night sweats	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Pruritus	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Pruritus generalised	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Rash	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Rash papular	0.43% 2/462 • Number of events 2 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Rash pruritic	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Surgical and medical procedures Sinus operation	0.65% 3/462 • Number of events 3 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Vascular disorders Hypertension	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
Vascular disorders Phlebitis	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.22% 1/462 • Number of events 1 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.	0.00% 0/462 • 12 months AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.

Additional Information

Mark Goldberg, MD

USAMRIID

Phone: 301-619-4562

Email: mark.goldberg@amedd.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place