Trial Outcomes & Findings for A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine. (NCT NCT02117570)

Last Updated: 2017-01-30

Results Overview

Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

185 participants

Primary outcome timeframe

From Day of Dose 1 vaccination to within 7 days after Dose 1

Results posted on

2017-01-30

Participant Flow

In Stage 1, 42 participants aged 50 to 64 years were randomized. After at least 14 days of post-Dose 2 blinded safety data for all Stage 1 participants was reviewed and determined safe, the study proceeded to Stage 2, during which 143 participants aged 65 to 85 years were randomized.

Participant milestones

Participant milestones
Measure	Placebo Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Stage 1 Participants Aged 50 to 64 Years STARTED	6	18	18
Stage 1 Participants Aged 50 to 64 Years Vaccine: Dose 1	6	18	18
Stage 1 Participants Aged 50 to 64 Years Vaccine: Dose 2	6	18	18
Stage 1 Participants Aged 50 to 64 Years Vaccine: Dose 3	6	17	18
Stage 1 Participants Aged 50 to 64 Years COMPLETED	5	15	17
Stage 1 Participants Aged 50 to 64 Years NOT COMPLETED	1	3	1
Stage 2 Participants Aged 65 to 85 Years STARTED	21	62	60
Stage 2 Participants Aged 65 to 85 Years Vaccine: Dose 1	21	61	60
Stage 2 Participants Aged 65 to 85 Years Vaccine: Dose 2	17	53	50
Stage 2 Participants Aged 65 to 85 Years Vaccine: Dose 3	4	12	12
Stage 2 Participants Aged 65 to 85 Years COMPLETED	20	59	54
Stage 2 Participants Aged 65 to 85 Years NOT COMPLETED	1	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Stage 1 Participants Aged 50 to 64 Years Withdrawal by Subject	0	2	1
Stage 1 Participants Aged 50 to 64 Years Lost to Follow-up	1	1	0
Stage 2 Participants Aged 65 to 85 Years Withdrawal by Subject	0	0	2
Stage 2 Participants Aged 65 to 85 Years Death	0	0	1
Stage 2 Participants Aged 65 to 85 Years Protocol Violation	0	0	1
Stage 2 Participants Aged 65 to 85 Years Lost to Follow-up	1	2	2
Stage 2 Participants Aged 65 to 85 Years Withdrew before vaccination	0	1	0

Baseline Characteristics

A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=79 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=78 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Total n=184 Participants Total of all reporting groups
Age, Customized Ages 50 to 64 years	6 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	42 Participants n=4 Participants
Age, Customized Ages 65 to 85 years	21 Participants n=5 Participants	61 Participants n=7 Participants	60 Participants n=5 Participants	142 Participants n=4 Participants
Sex/Gender, Customized Ages 50 to 64 years: Female	1 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants
Sex/Gender, Customized Ages 50 to 64 years: Male	5 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Sex/Gender, Customized Ages 65 to 85 years: Female	13 Participants n=5 Participants	37 Participants n=7 Participants	36 Participants n=5 Participants	86 Participants n=4 Participants
Sex/Gender, Customized Ages 65 to 85 years: Male	8 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	56 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Day of Dose 1 vaccination to within 7 days after Dose 1

Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 2 vaccination to within 14 days after Dose 2

Population: All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Pain at injection site: Any	0.0 Percentage of participants Interval 0.0 to 45.9	61.1 Percentage of participants Interval 35.7 to 82.7	66.7 Percentage of participants Interval 41.0 to 86.7
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Pain at injection site: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	44.4 Percentage of participants Interval 21.5 to 69.2	55.6 Percentage of participants Interval 30.8 to 78.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Pain at injection site: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	16.7 Percentage of participants Interval 3.6 to 41.4	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Pain at injection site: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Pain at injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Redness: Any	16.7 Percentage of participants Interval 0.4 to 64.1	11.1 Percentage of participants Interval 1.4 to 34.7	50.0 Percentage of participants Interval 26.0 to 74.0
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Redness: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	11.1 Percentage of participants Interval 1.4 to 34.7	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Redness: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Redness: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Swelling: Any	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Swelling: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Swelling: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Any local reaction: Any	16.7 Percentage of participants Interval 0.4 to 64.1	61.1 Percentage of participants Interval 35.7 to 82.7	83.3 Percentage of participants Interval 58.6 to 96.4
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Any local reaction: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	44.4 Percentage of participants Interval 21.5 to 69.2	55.6 Percentage of participants Interval 30.8 to 78.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Any local reaction: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	16.7 Percentage of participants Interval 3.6 to 41.4	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Any local reaction: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) Any local reaction: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5

PRIMARY outcome

Timeframe: From Day of Dose 3 vaccination to within 14 days after Dose 3

Population: All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 1 vaccination to within 7 days of Dose 1

Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine

Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 2 vaccination to within 14 days after Dose 2

Population: All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 3 vaccination to within 14 days after Dose 3

Population: All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)

Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine

An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) AEs	16.7 Participants Interval 0.4 to 64.1	33.3 Participants Interval 13.3 to 59.0	50.0 Participants Interval 26.0 to 74.0
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) SAEs	16.7 Participants Interval 0.4 to 64.1	11.1 Participants Interval 1.4 to 34.7	0 Participants Interval 0.0 to 18.5

PRIMARY outcome

Timeframe: From Day of Dose 1 vaccination to within 7 days of Dose 1

Population: All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 2 vaccination to 14 days after Dose 2

Population: All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=53 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=50 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Pain at injection site: Any	5.9 Percentage of participants Interval 0.1 to 28.7	66.0 Percentage of participants Interval 51.7 to 78.5	64.0 Percentage of participants Interval 49.2 to 77.1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Pain at injection site: Mild	5.9 Percentage of participants Interval 0.1 to 28.7	45.3 Percentage of participants Interval 31.6 to 59.6	48.0 Percentage of participants Interval 33.7 to 62.6
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Pain at injection site: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	18.9 Percentage of participants Interval 9.4 to 32.0	14.0 Percentage of participants Interval 5.8 to 26.7
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Pain at injection site: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Pain at injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Redness: Any	0.0 Percentage of participants Interval 0.0 to 19.5	22.6 Percentage of participants Interval 12.3 to 36.2	30.0 Percentage of participants Interval 17.9 to 44.6
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Redness: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	9.4 Percentage of participants Interval 3.1 to 20.7	8.0 Percentage of participants Interval 2.2 to 19.2
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Redness: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	5.7 Percentage of participants Interval 1.2 to 15.7	18.0 Percentage of participants Interval 8.6 to 31.4
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Redness: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	7.5 Percentage of participants Interval 2.1 to 18.2	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Swelling: Any	0.0 Percentage of participants Interval 0.0 to 19.5	26.4 Percentage of participants Interval 15.3 to 40.3	26.0 Percentage of participants Interval 14.6 to 40.3
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Swelling: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	11.3 Percentage of participants Interval 4.3 to 23.0	12.0 Percentage of participants Interval 4.5 to 24.3
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Swelling: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	9.4 Percentage of participants Interval 3.1 to 20.7	12.0 Percentage of participants Interval 4.5 to 24.3
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	5.7 Percentage of participants Interval 1.2 to 15.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Any local reaction: Any	5.9 Percentage of participants Interval 0.1 to 28.7	67.9 Percentage of participants Interval 53.7 to 80.1	70.0 Percentage of participants Interval 55.4 to 82.1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Any local reaction: Mild	5.9 Percentage of participants Interval 0.1 to 28.7	34.0 Percentage of participants Interval 21.5 to 48.3	34.0 Percentage of participants Interval 21.2 to 48.8
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Any local reaction: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	24.5 Percentage of participants Interval 13.8 to 38.3	30.0 Percentage of participants Interval 17.9 to 44.6
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Any local reaction: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	9.4 Percentage of participants Interval 3.1 to 20.7	6.0 Percentage of participants Interval 1.3 to 16.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) Any local reaction: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1

PRIMARY outcome

Timeframe: From Day of Dose 3 vaccination to 14 days after Dose 3

Population: All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 1 vaccination to within 7 days of Dose 1

Population: All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 2 vaccination to within 14 days after Dose 2

Population: All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: From Day of Dose 3 vaccination to within 14 days after Dose 3

Population: All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine

Outcome measures

PRIMARY outcome

Timeframe: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)

Population: All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=61 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=60 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) AEs	38.1 Percentage of participants Interval 18.1 to 61.6	36.1 Percentage of participants Interval 24.2 to 49.4	41.7 Percentage of participants Interval 29.1 to 55.1
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) SAEs	14.3 Percentage of participants Interval 3.0 to 36.3	3.3 Percentage of participants Interval 0.4 to 11.3	10.0 Percentage of participants Interval 3.8 to 20.5

Adverse Events

Placebo (50-64 Year Age Cohort)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo (65-85 Year Age Cohort)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (50-64 Year Age Cohort) n=6 participants at risk Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort) n=18 participants at risk Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort) n=18 participants at risk Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Placebo (65-85 Year Age Cohort) n=21 participants at risk Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort) n=61 participants at risk Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort) n=60 participants at risk Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Infections and infestations Cellulitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Gangrene	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Osteomyelitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	16.7% 1/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Bradycardia	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiac arrest	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Myocardial infarction	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Sinus arrest	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Cholelithiasis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pelvic abscess	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Seizure	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Device breakage	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Device malfunction	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Number of events 1 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Other adverse events
Measure	Placebo (50-64 Year Age Cohort) n=6 participants at risk Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort) n=18 participants at risk Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort) n=18 participants at risk Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Placebo (65-85 Year Age Cohort) n=21 participants at risk Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort) n=61 participants at risk Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort) n=60 participants at risk Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site erythema	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	16.7% 3/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.3% 5/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site pruritus	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Herpes zoster	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Localised infection	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Otitis media	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sinusitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Cervical radiculopathy	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Anxiety	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.6% 1/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Bradycardia	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Cardiac arrest	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Sinus arrest	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Influenza like illness	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site bruising	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site induration	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site rash	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site reaction	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Injection site swelling	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Immune system disorders Seasonal allergy	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Bronchitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Influenza	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pelvic abscess	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Skin candida	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Excoriation	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.3% 2/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.8% 1/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Sciatica	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Seizure	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Device malfunction	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Surgical and medical procedures Sinus operation	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.0% 3/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypotension	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Lymphoedema	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.7% 1/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Orthostatic hypotension	0.00% 0/6 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/18 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/21 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.6% 1/61 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/60 • Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc

Phone: 1-800-718-1021

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=6 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=17 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Pain at injection site: Any	0.0 Percentage of participants Interval 0.0 to 45.9	23.5 Percentage of participants Interval 6.8 to 49.9	44.4 Percentage of participants Interval 21.5 to 69.2
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Pain at injection site: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	23.5 Percentage of participants Interval 6.8 to 49.9	38.9 Percentage of participants Interval 17.3 to 64.3
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Pain at injection site: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Pain at injection site: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Pain at injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Redness: Any	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	44.4 Percentage of participants Interval 21.5 to 69.2
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Redness: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Redness: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Redness: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Swelling: Any	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	33.3 Percentage of participants Interval 13.3 to 59.0
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Swelling: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	16.7 Percentage of participants Interval 3.6 to 41.4
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Swelling: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	16.7 Percentage of participants Interval 3.6 to 41.4
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Any local reaction: Any	0.0 Percentage of participants Interval 0.0 to 45.9	23.5 Percentage of participants Interval 6.8 to 49.9	55.6 Percentage of participants Interval 30.8 to 78.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Any local reaction: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	23.5 Percentage of participants Interval 6.8 to 49.9	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Any local reaction: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Any local reaction: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) Any local reaction: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 18.5

Measure	Placebo n=6 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening muscle pain: Any	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening muscle pain: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/ worsening muscle pain: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening muscle pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening joint pain: Any	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening joint pain: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening joint pain: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) New/worsening joint pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Any systemic event: Any	16.7 Percentage of participants Interval 0.4 to 64.1	44.4 Percentage of participants Interval 21.5 to 69.2	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Any systemic event: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	22.2 Percentage of participants Interval 6.4 to 47.6	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Any systemic event: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	22.2 Percentage of participants Interval 6.4 to 47.6	16.7 Percentage of participants Interval 3.6 to 41.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fever: Any	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fever: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fever: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fever: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fever: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Vomiting: Any	16.7 Percentage of participants Interval 0.4 to 64.1	5.6 Percentage of participants Interval 0.1 to 27.3	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Vomiting: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	5.6 Percentage of participants Interval 0.1 to 27.3	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Any systemic event: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Vomiting: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Any systemic event: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Diarrhea: Any	16.7 Percentage of participants Interval 0.4 to 64.1	22.2 Percentage of participants Interval 6.4 to 47.6	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Diarrhea: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	22.2 Percentage of participants Interval 6.4 to 47.6	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Diarrhea: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Diarrhea: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Headache: Any	0.0 Percentage of participants Interval 0.0 to 45.9	16.7 Percentage of participants Interval 3.6 to 41.4	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Headache: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	16.7 Percentage of participants Interval 3.6 to 41.4	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Headache: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Headache: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Headache: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fatigue: Any	0.0 Percentage of participants Interval 0.0 to 45.9	22.2 Percentage of participants Interval 6.4 to 47.6	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fatigue: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fatigue: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	22.2 Percentage of participants Interval 6.4 to 47.6	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fatigue: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) Fatigue: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5

Measure	Placebo n=6 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=18 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening muscle pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening joint pain: Any	16.7 Percentage of participants Interval 0.4 to 64.1	33.3 Percentage of participants Interval 13.3 to 59.0	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening joint pain: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	27.8 Percentage of participants Interval 9.7 to 53.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening joint pain: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/ worsening joint pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Any systemic event: Any	33.3 Percentage of participants Interval 4.3 to 77.7	44.4 Percentage of participants Interval 21.5 to 69.2	55.6 Percentage of participants Interval 30.8 to 78.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Any systemic event: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	16.7 Percentage of participants Interval 3.6 to 41.4	27.8 Percentage of participants Interval 9.7 to 53.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Any systemic event: Moderate	16.7 Percentage of participants Interval 0.4 to 64.1	22.2 Percentage of participants Interval 6.4 to 47.6	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Any systemic event: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Any systemic event: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fever: Any	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fever: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fever: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fever: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fever: Grade 4	0.0 Percentage of participants Interval 0.0 to 49.5	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Vomiting: Any	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Vomiting: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Vomiting: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Diarrhea: Any	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Diarrhea: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Diarrhea: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Diarrhea: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Headache: Any	0.0 Percentage of participants Interval 0.0 to 45.9	22.2 Percentage of participants Interval 6.4 to 47.6	33.3 Percentage of participants Interval 13.3 to 59.0
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Headache: Mild	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	22.2 Percentage of participants Interval 6.4 to 47.6
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Headache: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	11.1 Percentage of participants Interval 1.4 to 34.7	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Headache: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Headache: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fatigue: Any	33.3 Percentage of participants Interval 4.3 to 77.7	38.9 Percentage of participants Interval 17.3 to 64.3	33.3 Percentage of participants Interval 13.3 to 59.0
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fatigue: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	16.7 Percentage of participants Interval 3.6 to 41.4	16.7 Percentage of participants Interval 3.6 to 41.4
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fatigue: Moderate	16.7 Percentage of participants Interval 0.4 to 64.1	16.7 Percentage of participants Interval 3.6 to 41.4	16.7 Percentage of participants Interval 3.6 to 41.4
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fatigue: Severe	0.0 Percentage of participants Interval 0.0 to 45.9	0.0 Percentage of participants Interval 0.0 to 18.5	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) Fatigue: Grade 4	0.0 Percentage of participants Interval 0.0 to 45.9	5.6 Percentage of participants Interval 0.1 to 27.3	0.0 Percentage of participants Interval 0.0 to 18.5
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening muscle pain: Any	16.7 Percentage of participants Interval 0.4 to 64.1	27.8 Percentage of participants Interval 9.7 to 53.5	11.1 Percentage of participants Interval 1.4 to 34.7
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening muscle pain: Mild	16.7 Percentage of participants Interval 0.4 to 64.1	11.1 Percentage of participants Interval 1.4 to 34.7	5.6 Percentage of participants Interval 0.1 to 27.3
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) New/worsening muscle pain: Moderate	0.0 Percentage of participants Interval 0.0 to 45.9	16.7 Percentage of participants Interval 3.6 to 41.4	0.0 Percentage of participants Interval 0.0 to 18.5

Measure	Placebo n=4 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=12 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=12 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Pain at injection site: Any	0.0 Percentage of participants Interval 0.0 to 60.2	25.0 Percentage of participants Interval 5.5 to 57.2	25.0 Percentage of participants Interval 5.5 to 57.2
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Pain at injection site: Mild	0.0 Percentage of participants Interval 0.0 to 60.2	16.7 Percentage of participants Interval 2.1 to 48.4	16.7 Percentage of participants Interval 2.1 to 48.4
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Pain at injection site: Moderate	0.0 Percentage of participants Interval 0.0 to 600.2	8.3 Percentage of participants Interval 0.2 to 38.5	8.3 Percentage of participants Interval 0.2 to 38.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Pain at injection site: Severe	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Pain at injection site: Grade 4	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Redness: Any	0.0 Percentage of participants Interval 0.0 to 60.2	8.3 Percentage of participants Interval 0.2 to 38.5	8.3 Percentage of participants Interval 0.2 to 38.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Redness: Mild	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	8.3 Percentage of participants Interval 0.2 to 38.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Redness: Moderate	0.0 Percentage of participants Interval 0.0 to 60.2	8.3 Percentage of participants Interval 0.2 to 38.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Redness: Severe	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Redness: Grade 4	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Swelling: Any	0.0 Percentage of participants Interval 0.0 to 60.2	25.0 Percentage of participants Interval 5.5 to 57.2	16.7 Percentage of participants Interval 2.1 to 48.4
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Swelling: Mild	0.0 Percentage of participants Interval 0.0 to 60.2	16.7 Percentage of participants Interval 2.1 to 48.4	16.7 Percentage of participants Interval 2.1 to 48.4
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Swelling: Moderate	0.0 Percentage of participants Interval 0.0 to 60.2	8.3 Percentage of participants Interval 0.2 to 38.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Swelling: Grade 4	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Any local reaction: Any	0.0 Percentage of participants Interval 0.0 to 60.2	33.3 Percentage of participants Interval 9.9 to 65.1	25.0 Percentage of participants Interval 5.5 to 57.2
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Any local reaction: Mild	0.0 Percentage of participants Interval 0.0 to 60.2	16.7 Percentage of participants Interval 2.1 to 48.4	16.7 Percentage of participants Interval 2.1 to 48.4
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Any local reaction: Moderate	0.0 Percentage of participants Interval 0.0 to 60.2	16.7 Percentage of participants Interval 2.1 to 48.4	8.3 Percentage of participants Interval 0.2 to 38.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Any local reaction: Severe	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) Any local reaction: Grade 4	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 26.5	0.0 Percentage of participants Interval 0.0 to 26.5

Measure	Placebo n=17 Participants Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 100 µg n=53 Participants Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.	Clostridium Difficile Vaccine, 200 µg n=50 Participants Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Headache: Mild	17.6 Percentage of participants Interval 3.8 to 43.4	17.0 Percentage of participants Interval 8.1 to 29.8	12.0 Percentage of participants Interval 4.5 to 24.3
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Headache: Moderate	5.9 Percentage of participants Interval 0.1 to 28.7	9.4 Percentage of participants Interval 3.1 to 20.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Headache: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Headache: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fatigue: Any	17.6 Percentage of participants Interval 3.8 to 43.4	39.6 Percentage of participants Interval 26.5 to 54.0	32.0 Percentage of participants Interval 19.5 to 46.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fatigue: Mild	11.8 Percentage of participants Interval 1.5 to 36.4	20.8 Percentage of participants Interval 10.8 to 34.1	20.0 Percentage of participants Interval 10.0 to 33.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fatigue: Moderate	5.9 Percentage of participants Interval 0.1 to 28.7	18.9 Percentage of participants Interval 9.4 to 32.0	12.0 Percentage of participants Interval 4.5 to 24.3
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fatigue: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fatigue: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening muscle pain: Any	11.8 Percentage of participants Interval 1.5 to 36.4	26.4 Percentage of participants Interval 15.3 to 40.3	24.0 Percentage of participants Interval 13.1 to 38.2
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening muscle pain: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	17.0 Percentage of participants Interval 8.1 to 29.8	14.0 Percentage of participants Interval 5.8 to 26.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening muscle pain: Moderate	11.8 Percentage of participants Interval 1.5 to 36.4	9.4 Percentage of participants Interval 3.1 to 20.7	10.0 Percentage of participants Interval 3.3 to 21.8
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening muscle pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening joint pain: Any	11.8 Percentage of participants Interval 1.5 to 36.4	20.8 Percentage of participants Interval 10.8 to 34.1	14.0 Percentage of participants Interval 5.8 to 26.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening joint pain: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	13.2 Percentage of participants Interval 5.5 to 25.3	10.0 Percentage of participants Interval 3.3 to 21.8
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening joint pain: Moderate	11.8 Percentage of participants Interval 1.5 to 36.4	7.5 Percentage of participants Interval 2.1 to 18.2	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) New/worsening joint pain: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Any systemic event: Any	35.3 Percentage of participants Interval 14.2 to 61.7	50.9 Percentage of participants Interval 36.8 to 64.9	58.0 Percentage of participants Interval 43.2 to 71.8
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Any systemic event: Mild	5.9 Percentage of participants Interval 0.1 to 28.7	17.0 Percentage of participants Interval 8.1 to 29.8	34.0 Percentage of participants Interval 21.2 to 48.8
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Any systemic event: Moderate	29.4 Percentage of participants Interval 10.3 to 56.0	32.1 Percentage of participants Interval 19.9 to 46.3	20.0 Percentage of participants Interval 10.0 to 33.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Any systemic event: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Any systemic event: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fever: Any	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fever: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fever: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fever: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Fever: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Vomiting: Any	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Vomiting: Mild	0.0 Percentage of participants Interval 0.0 to 19.5	1.9 Percentage of participants Interval 0.0 to 10.1	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Vomiting: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Diarrhea: Any	23.5 Percentage of participants Interval 6.8 to 49.9	17.0 Percentage of participants Interval 8.1 to 29.8	18.0 Percentage of participants Interval 8.6 to 31.4
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Diarrhea: Mild	5.9 Percentage of participants Interval 0.1 to 28.7	7.5 Percentage of participants Interval 2.1 to 18.2	16.0 Percentage of participants Interval 7.2 to 29.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Diarrhea: Moderate	17.6 Percentage of participants Interval 3.8 to 43.4	9.4 Percentage of participants Interval 3.1 to 20.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Diarrhea: Grade 4	0.0 Percentage of participants Interval 0.0 to 19.5	0.0 Percentage of participants Interval 0.0 to 6.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) Headache: Any	23.5 Percentage of participants Interval 6.8 to 49.9	26.4 Percentage of participants Interval 15.3 to 40.3	14.0 Percentage of participants Interval 5.8 to 26.7