Trial Outcomes & Findings for Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD) (NCT NCT02925793)

NCT ID: NCT02925793

Last Updated: 2022-11-22

Results Overview

Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 327 participants
• Primary outcome timeframe: Baseline and Week 8
• Results posted on: 2022-11-22

Participant Flow

Approximately 300 patients (100 per treatment group), with mild to moderate Atopic Dermatitis (AD) were to be included in this study.

Eligible patients were randomized (1:1:1) to receive either 1% DS107 cream, 5% DS107 cream or, vehicle cream.

Participant milestones

Measure	Vehicle Cream Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Overall Study STARTED	106	110	111
Overall Study COMPLETED	81	81	83
Overall Study NOT COMPLETED	25	29	28

Reasons for withdrawal

Measure	Vehicle Cream Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Overall Study Adverse Event	3	3	6
Overall Study Withdrawal by Subject	16	15	13
Overall Study Investigator Discretion	0	1	1
Overall Study Lost to Follow-up	2	3	1
Overall Study Lack of Efficacy	2	6	4
Overall Study Other:	2	1	3

Baseline Characteristics

Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)

Baseline characteristics by cohort

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	Total n=326 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 16.54 • n=5 Participants	38.2 years STANDARD_DEVIATION 15.13 • n=7 Participants	43.2 years STANDARD_DEVIATION 16.06 • n=5 Participants	40.6 years STANDARD_DEVIATION 15.91 • n=4 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	75 Participants n=7 Participants	50 Participants n=5 Participants	188 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	35 Participants n=7 Participants	60 Participants n=5 Participants	138 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	61 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	48 Participants n=7 Participants	50 Participants n=5 Participants	153 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=72 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=74 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=77 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8	-3.8 score on a scale Standard Deviation 2.66	-2.9 score on a scale Standard Deviation 2.66	-2.9 score on a scale Standard Deviation 2.31

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change from baseline in EASI in treated population compared to vehicle population at Week 8. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

• 0 = none
• 1 = mild
• 2 = moderate
• 3 = severe A decrease in EASI indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=80 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=80 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=83 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8	-7.96 score on a scale Standard Deviation 8.504	-7.26 score on a scale Standard Deviation 7.287	-8.44 score on a scale Standard Deviation 7.603

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6 and Week 10

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were asked to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 Week 2	-1.5 score on a scale Standard Deviation 1.88	-1.1 score on a scale Standard Deviation 1.68	-1.4 score on a scale Standard Deviation 1.92
Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 Week 4	-2.7 score on a scale Standard Deviation 1.99	-2.1 score on a scale Standard Deviation 2.45	-2.1 score on a scale Standard Deviation 1.95
Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 Week 8	-3.3 score on a scale Standard Deviation 2.44	-2.7 score on a scale Standard Deviation 2.61	-2.5 score on a scale Standard Deviation 2.08
Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 Week 10	-3.8 score on a scale Standard Deviation 2.74	-2.9 score on a scale Standard Deviation 2.90	-3.0 score on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: 10 weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

• Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable)

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. Week 2	0.19 Proportion of participants	0.14 Proportion of participants	0.15 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. Week 4	0.38 Proportion of participants	0.26 Proportion of participants	0.28 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. Week 6	0.41 Proportion of participants	0.31 Proportion of participants	0.39 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. Week 8	0.45 Proportion of participants	0.31 Proportion of participants	0.4 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. Week 10	0.42 Proportion of participants	0.31 Proportion of participants	0.35 Proportion of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 10

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

• 0 = none
• 1 = mild
• 2 = moderate
• 3 = severe A decrease in EASI indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. Week 2	-3.14 score on a scale Standard Deviation 4.387	-3.13 score on a scale Standard Deviation 5.390	-2.72 score on a scale Standard Deviation 4.776
Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. Week 4	-6.19 score on a scale Standard Deviation 6.705	-5.43 score on a scale Standard Deviation 6.358	-5.57 score on a scale Standard Deviation 6.765
Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. Week 6	-7.28 score on a scale Standard Deviation 7.518	-6.45 score on a scale Standard Deviation 7.198	-7.40 score on a scale Standard Deviation 7.248
Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. Week 10	-8.47 score on a scale Standard Deviation 8.474	-7.69 score on a scale Standard Deviation 7.143	-8.74 score on a scale Standard Deviation 7.769

SECONDARY outcome

Timeframe: 10 weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

• 0 = none
• 1 = mild
• 2 = moderate
• 3 = severe A decrease in EASI indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 2	0.03 Proportion of participants	0.05 Proportion of participants	0.03 Proportion of participants
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 4	0.07 Proportion of participants	0.10 Proportion of participants	0.08 Proportion of participants
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 6	0.11 Proportion of participants	0.12 Proportion of participants	0.14 Proportion of participants
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 8	0.14 Proportion of participants	0.17 Proportion of participants	0.23 Proportion of participants
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 10	0.12 Proportion of participants	0.15 Proportion of participants	0.25 Proportion of participants

SECONDARY outcome

Timeframe: 10 weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

The IGA scale awards a score of 0˗4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment.

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 2	0.03 Proportion of participants	0.05 Proportion of participants	0.03 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 4	0.07 Proportion of participants	0.10 Proportion of participants	0.08 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 6	0.11 Proportion of participants	0.12 Proportion of participants	0.14 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 8	0.14 Proportion of participants	0.17 Proportion of participants	0.23 Proportion of participants
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. Week 10	0.12 Proportion of participants	0.15 Proportion of participants	0.25 Proportion of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

The Global Investigator Assessment scale (IGA) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3

= moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

Outcome measures

Measure	Vehicle Cream n=106 Participants Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 Participants 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=110 Participants 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. Week 2	-0.18 score on a scale Standard Deviation 0.562	-0.27 score on a scale Standard Deviation 0.604	-0.26 score on a scale Standard Deviation 0.585
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. Week 4	-0.33 score on a scale Standard Deviation 0.719	-0.57 score on a scale Standard Deviation 0.737	-0.44 score on a scale Standard Deviation 0.709
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. Week 6	-0.49 score on a scale Standard Deviation 0.840	-0.70 score on a scale Standard Deviation 0.822	-0.70 score on a scale Standard Deviation 0.827
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. Week 8	-0.78 score on a scale Standard Deviation 0.871	-0.85 score on a scale Standard Deviation 0.896	-0.92 score on a scale Standard Deviation 0.953
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. Week 10	-0.73 score on a scale Standard Deviation 0.881	-0.80 score on a scale Standard Deviation 0.858	-0.98 score on a scale Standard Deviation 0.987

Adverse Events

Vehicle Cream

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

1% DS107 Cream

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

5% DS107 Cream

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle Cream n=106 participants at risk Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 participants at risk 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=111 participants at risk 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Eye disorders Conjunctivitis allergic	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.

Other adverse events

Measure	Vehicle Cream n=106 participants at risk Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream	1% DS107 Cream n=110 participants at risk 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107	5% DS107 Cream n=111 participants at risk 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107
Infections and infestations Sinusitis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Blood and lymphatic system disorders Monocytosis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Blood and lymphatic system disorders Neutropenia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Cardiac disorders Tachycardia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Cheilitis	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Colitis Ulcerative	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Dental Caries	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Diarrhoea	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Hiatus Hernia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Nausea	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Gastrointestinal disorders Toothache	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Skin Bacterial Infection	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Erythema	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Inflammation	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Pain	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	3.6% 4/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Pruritus	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Reaction	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Application Site Swelling	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Influenza Like Illness	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Malaise	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Pain	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Peripheral Swelling	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Swelling	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
General disorders Xerosis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Immune system disorders Drug Hypersensitivity	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Bronchitis	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Cellulitis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Dermatitis Infected	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Folliculitis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Fungal Infection	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Furuncle	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Gastroenteritis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Gastroenteritis Viral	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Helicobacter Zoster	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Herpes Zoster	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Impetigo	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Infection	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Influenza	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Otitis Media Acute	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Perineal Infection	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Pharyngitis	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Soft Tissue Infection	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Staphylococcal Infection	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Tooth Abscess	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Upper Respiratory Tract Infection	4.7% 5/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	3.6% 4/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Urinary Tract Infection	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Infections and infestations Viral Upper Respiratory Tract Infection	4.7% 5/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	5.5% 6/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Arthropod Bite	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Cataract Operation Complication	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Contusion	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Heat Stroke	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Joint Injury	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Laceration	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Ligament Sprain	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Sunburn	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Injury, poisoning and procedural complications Tooth Injury	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Investigations Blood Creatine Phosphokinase	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Investigations Blood Creatinine Increased	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Investigations Hepatic Enzyme Increased	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Metabolism and nutrition disorders Hypokalaemia	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Arthralgia	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Back Pain	2.8% 3/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma Benign	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Nervous system disorders Headache	4.7% 5/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	3.6% 4/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Nervous system disorders Migraine	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Nervous system disorders Paraesthesia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Nervous system disorders Syncope	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Nervous system disorders Tension Headache	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Psychiatric disorders Depression	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Psychiatric disorders Insomnia	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Acne	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Dermatitis Atopic	3.8% 4/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	4.5% 5/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Dry Skin	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Ecchymosis	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Eczema	3.8% 4/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	4.5% 5/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Erythema	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Intertrigo	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Pruritus	2.8% 3/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	3.6% 4/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Rash	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Scab	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Skin Burning Sensation	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Skin Fissures	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Skin Tightness	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Skin and subcutaneous tissue disorders Urticaria	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Surgical and medical procedures Tonsillectomy	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Surgical and medical procedures Tooth Extraction	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.90% 1/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Vascular disorders Hypertension	0.94% 1/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	1.8% 2/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Vascular disorders Hypotension	0.00% 0/106 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.91% 1/110 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.	0.00% 0/111 • Up to 10 weeks Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.

Additional Information

Study Director

DS Biopharma

Phone: +35312933590

Email: regulatory.dsbiopharma@dsbiopharma.com

Results disclosure agreements

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