Trial Outcomes & Findings for Study of Two Digital Therapeutics for the Prevention of Episodic Migraine (NCT NCT05853900)

Last Updated: 2025-07-03

Results Overview

Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12).

Recruitment status

COMPLETED

Study phase

Target enrollment

568 participants

Primary outcome timeframe

Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Results posted on

2025-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (CT-132) Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Overall Study STARTED	285	283
Overall Study COMPLETED	255	262
Overall Study NOT COMPLETED	30	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (CT-132) n=285 Participants Mobile application A (CT-132) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=283 Participants Mobile application B (Digital Control) is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.	Total n=568 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	38.9 years STANDARD_DEVIATION 10.3 • n=7 Participants	38.7 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex/Gender, Customized Female	263 Participants n=5 Participants	265 Participants n=7 Participants	528 Participants n=5 Participants
Sex/Gender, Customized Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex/Gender, Customized Other	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	275 Participants n=5 Participants	270 Participants n=7 Participants	545 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	269 Participants n=5 Participants	261 Participants n=7 Participants	530 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	285 Participants n=5 Participants	283 Participants n=7 Participants	568 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Population: Intent-to-treat Population, all enrolled participants who were randomized, based on the assigned intervention in the randomization and recorded in the database.

Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12).

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change in MMD (Monthly Migraine Days)	-3.04 migraine days per month Interval -3.49 to -2.58	-2.14 migraine days per month Interval -2.59 to -1.69

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Participants who have at least a 50% reduction from baseline (28-day Run-in Period) in the number of MMDs to Week 12 (previous 28 days, Week 9 through Week 12)

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Participants Who Have at Least a 50% Reduction From Baseline Responder	141 Participants	113 Participants
Participants Who Have at Least a 50% Reduction From Baseline Non-responder	125 Participants	151 Participants

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Weeks 4 and 8

Population: The overall number of participant analyzed present the number of participant with data at the time interval the assessment was complete (at week 4 and at week 8).

Change from baseline (28-day Run-in Period) in the number of MMDs recorded over the previous 28 days at Week 4 and at Week 8

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=285 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=283 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8 Change from Baseline at Week 4	-1.58 migraine days per month Standard Deviation 3.55	-1.20 migraine days per month Standard Deviation 3.31
Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8 Change from Baseline at Week 8	-2.24 migraine days per month Standard Deviation 3.92	-1.87 migraine days per month Standard Deviation 3.65

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12

Change from baseline (28-day Run-in Period) in the mean number of MMDs over 12 weeks.

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change From Baseline in the Mean Number of MMD Over 12 Weeks	-3.35 migraine days per month Standard Deviation 3.63	-2.26 migraine days per month Standard Deviation 3.67

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Change in the number of headaches with at least moderate severity from baseline (28-day run-in period) to Week 12 (previous 28 days, Week 9 through Week 12).

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12	-3.48 headaches Standard Deviation 2.66	-2.87 headaches Standard Deviation 2.64

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Weeks 4, 8 and 12.

Population: The overall number of participant analyzed present the number of participant with data at the time-interval the assessment was complete (at week 4, at week 8 and at week 12).

Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12 The MSQ is a self-administered, 14-item instrument that is completed at baseline, Week 4, Week 8, and Week 12. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=284 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=283 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12 Change from Baseline to Week 4	6.16 score on a scale Standard Deviation 13.48	2.12 score on a scale Standard Deviation 13.42
Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12 Change from Baseline to Week 8	9.13 score on a scale Standard Deviation 15.82	4.30 score on a scale Standard Deviation 13.85
Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12 Change from Baseline to Week 12	11.95 score on a scale Standard Deviation 15.52	5.03 score on a scale Standard Deviation 16.26

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 8, and 12

Population: The overall number of participant analyzed present the number of participant with data at the time interval the assessment was complete (at week 4, at week 8, and at week 12).

Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12 The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self report 5-item questionnaire (scale: 0 - 90 for each of 5 subscales) designed to quantify headache-related disability over a 3-month period. The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability.

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=285 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=283 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12) Change from Baseline at Week 4	-5.27 score on a scale Standard Deviation 29.89	-0.89 score on a scale Standard Deviation 30.31
Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12) Change from Baseline at Week 8	-7.50 score on a scale Standard Deviation 31.14	-0.85 score on a scale Standard Deviation 33.27
Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12) Change from Baseline at Week 12	-10.55 score on a scale Standard Deviation 33.03	-3.30 score on a scale Standard Deviation 29.52

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Change in the number of migraines with use of an acute migraine medications from the run-in period to Weeks 9-12. The number of migraines with use of an acute medication will be counted for the run-in period and for post randomization period. The change from baseline will be calculated as number of migraines in weeks 9-12 minus number of migraines in the run-in period with use of an acute medication.

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication	-2.70 migraine Standard Deviation 2.38	-2.50 migraine Standard Deviation 2.42

SECONDARY outcome

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Change in the number of monthly headache days from baseline to Weeks 9-12

Outcome measures

Outcome measures
Measure	Arm A (CT-132) n=266 Participants Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B (Digital Control) n=264 Participants Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12	-4.86 headache days per month Standard Deviation 4.29	-3.69 headache days per month Standard Deviation 4.08

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=278 participants at risk Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B n=278 participants at risk Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Infections and infestations peritonsillar abscess	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).

Other adverse events

Additional Information

Clinical Development

Click Therapeutics

Phone: 347-460-8607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A n=278 participants at risk Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.	Arm B n=278 participants at risk Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
Infections and infestations Mastitis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Peritonsillar abscess	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Vulvovaginal candidiasis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Abdominal infection	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Bacterial vaginosis	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations COVID-19 pneumonia	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Otitis media	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Respiratory tract infection	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Urinary tract infection	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.72% 2/278 • Number of events 2 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Injury, poisoning and procedural complications Cartilage injury	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Injury, poisoning and procedural complications Muscle strain	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Animal bite	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Metabolism and nutrition disorders Hypercholesterolaemia	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Metabolism and nutrition disorders Vitamin D deficiency	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Nervous system disorders Migraine	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Nervous system disorders Syncope	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Nervous system disorders Status migrainosus	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Psychiatric disorders Anxiety	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Psychiatric disorders Depressive symptom	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Psychiatric disorders Panic attack	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Cardiac disorders Angina pectoris	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Ear and labyrinth disorders Tympanic membrane perforation	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Gastrointestinal disorders Gastroesophageal reflux disease	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Gastrointestinal disorders Haematochezia	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
General disorders Peripheral swelling	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
General disorders Procedural pain	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Hepatobiliary disorders Cholecystitis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations COVID-19	0.72% 2/278 • Number of events 2 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.72% 2/278 • Number of events 2 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Sinusitis	0.72% 2/278 • Number of events 2 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Bronchitis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Conjunctivitis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Gastroenteritis	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.00% 0/278 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).
Infections and infestations Influenza	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).	0.36% 1/278 • Number of events 1 • Baseline (28-day run-in period) through Week 12 (up to 16 weeks). Safety population included all randomized participants who were exposed to the study intervention (completed at least one task).