Trial Outcomes & Findings for A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis (NCT NCT01916226)

NCT ID: NCT01916226

Last Updated: 2018-06-20

Results Overview

The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 682 participants
• Primary outcome timeframe: Baseline through the entire treatment period (2 weeks)
• Results posted on: 2018-06-20

Participant Flow

In anticipation of a 5% to 8% dropout rate, this study planned enrolment of 156 participants per treatment group in order to target 144 participants per treatment group, who would provide a full 2 weeks' worth of data.

A total of 978 participants were screened for this study. Of these, 73 were pre-screen failures and 223 were screening/run-in failures. A total of 682 participants were randomized (1:1:1:1 ratio) to receive study treatment.

Participant milestones

Measure	FPNS 200 μg Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.	Cetirizine 10 mg Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Overall Study STARTED	170	170	171	171
Overall Study COMPLETED	169	169	168	167
Overall Study NOT COMPLETED	1	1	3	4

Reasons for withdrawal

Measure	FPNS 200 μg Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.	Cetirizine 10 mg Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Overall Study Adverse Event	1	0	1	1
Overall Study Lack of Efficacy	0	0	2	1
Overall Study Protocol Violation	0	1	0	1
Overall Study Physician Decision	0	0	0	1

Baseline Characteristics

A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Measure	FPNS 200 μg n=170 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.	Cetirizine 10 mg n=170 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.	Total n=682 Participants Total of all reporting groups
Age, Continuous	40.1 Years STANDARD_DEVIATION 10.66 • n=5 Participants	39.2 Years STANDARD_DEVIATION 11.41 • n=7 Participants	41.3 Years STANDARD_DEVIATION 11.29 • n=5 Participants	40.4 Years STANDARD_DEVIATION 11.84 • n=4 Participants	40.3 Years STANDARD_DEVIATION 11.31 • n=21 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	113 Participants n=7 Participants	110 Participants n=5 Participants	109 Participants n=4 Participants	428 Participants n=21 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	57 Participants n=7 Participants	61 Participants n=5 Participants	62 Participants n=4 Participants	254 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	34 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants	35 Participants n=4 Participants	120 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	129 Participants n=5 Participants	142 Participants n=7 Participants	128 Participants n=5 Participants	127 Participants n=4 Participants	526 Participants n=21 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Not Captured by Study Site	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.

The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

Outcome measures

Measure	FPNS 200 μg n=169 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=169 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period	-2.2 Scores on a scale Standard Error 0.19	-1.9 Scores on a scale Standard Error 0.18	-1.5 Scores on a scale Standard Error 0.18	-0.9 Scores on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.

Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

Outcome measures

Measure	FPNS 200 μg n=169 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=169 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period Runny nose	-0.5 Scores on a scale Standard Error 0.05	-0.4 Scores on a scale Standard Error 0.05	-0.4 Scores on a scale Standard Error 0.05	-0.3 Scores on a scale Standard Error 0.05
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period Nasal congestion	-0.5 Scores on a scale Standard Error 0.05	-0.4 Scores on a scale Standard Error 0.04	-0.3 Scores on a scale Standard Error 0.05	-0.2 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period Nasal itching	-0.6 Scores on a scale Standard Error 0.05	-0.5 Scores on a scale Standard Error 0.05	-0.4 Scores on a scale Standard Error 0.05	-0.2 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period Sneezing	-0.6 Scores on a scale Standard Error 0.05	-0.6 Scores on a scale Standard Error 0.05	-0.4 Scores on a scale Standard Error 0.05	-0.2 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal

Population: ITT Population

The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.

Outcome measures

Measure	FPNS 200 μg n=170 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=170 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.	-1.0 Scores on a scale Standard Error 0.10	-0.6 Scores on a scale Standard Error 0.09	-0.8 Scores on a scale Standard Error 0.10	-0.5 Scores on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.

The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that "instant." The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.

Outcome measures

Measure	FPNS 200 μg n=169 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=169 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period	-1.9 Scores on a scale Standard Error 0.18	-1.3 Scores on a scale Standard Error 0.17	-1.2 Scores on a scale Standard Error 0.18	-0.6 Scores on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater

The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

Outcome measures

Measure	FPNS 200 μg n=150 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=137 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=152 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=146 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period	-1.6 Scores on a scale Standard Error 0.16	-1.4 Scores on a scale Standard Error 0.16	-1.2 Scores on a scale Standard Error 0.16	-0.8 Scores on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: Ocular Population

The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that "instant." The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

Outcome measures

Measure	FPNS 200 μg n=150 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=137 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=152 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=146 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period	-1.3 Scores on a scale Standard Error 0.15	-1.1 Scores on a scale Standard Error 0.14	-1.1 Scores on a scale Standard Error 0.16	-0.5 Scores on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n

The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.

Outcome measures

Measure	FPNS 200 μg n=150 Participants Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks	Cetirizine 10 mg n=137 Participants Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=152 Participants Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=146 Participants Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period	-3.9 Scores on a scale Standard Error 0.34	-3.4 Scores on a scale Standard Error 0.34	-2.7 Scores on a scale Standard Error 0.34	-1.7 Scores on a scale Standard Error 0.30

Adverse Events

FPNS 200 μg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Cetirizine 10 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

FPNS Matching Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Cetirizine Matching Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FPNS 200 μg n=170 participants at risk Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.	Cetirizine 10 mg n=170 participants at risk Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.	FPNS Matching Placebo n=171 participants at risk Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.	Cetirizine Matching Placebo n=171 participants at risk Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
Infections and infestations Fungal infection	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Gastroenteritis viral	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Sinusitis	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	1.2% 2/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Viral upper respiratory tract infection	1.2% 2/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Ear infection	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Oral herpes	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Headache	1.2% 2/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	1.8% 3/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	1.2% 2/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	1.8% 3/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Sinus headache	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Somnolence	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	1.2% 2/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Dysphagia	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Toothache	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Ear and labyrinth disorders Ear pain	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Eye disorders Conjunctivitis	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Eye disorders Conjunctivitis allergic	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Fatigue	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Psychiatric disorders Depression	0.59% 1/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/170 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the End-of-Study visit (up to Day 14). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.

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