Trial Outcomes & Findings for Evaluation of the Presence of SENS-401 in the Perilymph (NCT NCT05258773)

Last Updated: 2025-04-23

Results Overview

A sample of perilymph was obtained from the round window during the cochlear implant surgery from Arm A participants only, after seven days of SENS-401. The percentage of participants with levels of SENS-401 in the perilymph above the Limit of Quantification was then calculated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Day 8

Results posted on

2025-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	A, Treatment Arm Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Overall Study STARTED	18	10
Overall Study COMPLETED	16	8
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	A, Treatment Arm Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Overall Study Screen Failure	1	1
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A, Treatment Arm n=17 Participants Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm n=10 Participants Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants	0 Participants n=10 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=17 Participants	6 Participants n=10 Participants	16 Participants n=27 Participants
Age, Categorical >=65 years	7 Participants n=17 Participants	4 Participants n=10 Participants	11 Participants n=27 Participants
Age, Continuous	61.67 years STANDARD_DEVIATION 13.602 • n=17 Participants	61.52 years STANDARD_DEVIATION 14.968 • n=10 Participants	61.61 years STANDARD_DEVIATION 13.835 • n=27 Participants
Sex: Female, Male Female	11 Participants n=17 Participants	6 Participants n=10 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=17 Participants	4 Participants n=10 Participants	10 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Australia	5 participants n=17 Participants	4 participants n=10 Participants	9 participants n=27 Participants
Region of Enrollment France	12 participants n=17 Participants	6 participants n=10 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 8

Population: The pharmacokinetic (PK) Set included all participants who received at least one dose of SENS-401 (16). Note that one (1) participant treated with SENS-401 did not have a perilymph sample collected during cochlear implant surgery so the overall number of participants analyzed for this outcome is 15.

Outcome measures

Outcome measures
Measure	A, Treatment Arm n=15 Participants Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Proportion of Participants With SENS-401 Detected in Perilymph	15 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 8

SENS-401 perilymph concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).

Outcome measures

Outcome measures
Measure	A, Treatment Arm n=15 Participants Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
SENS-401 Perilymph Concentration	45.8009 ng/ml Standard Deviation 45.47158	—

SECONDARY outcome

Timeframe: Day 8

Population: The pharmacokinetic (PK) Set included all participants who received at least one dose of SENS-401 (16).

SENS-401 plasma concentration on day of cochlear implant surgery after seven days of SENS-401 (arm A only).

Outcome measures

Outcome measures
Measure	A, Treatment Arm n=16 Participants Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
SENS-401 Plasma Concentration	59.6244 ng/ml Standard Deviation 27.98319	—

SECONDARY outcome

Timeframe: Day 49 and Day 105

Population: Efficacy Set included all participants who have at least hearing threshold parameter data at Baseline and Day 49

Pure tone audiometry (PTA) in decibels (dB) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition. PTA assessments were conducted on Day 1 after randomization (prior to the first dose of the study drug for Arm A), at the Day 49 visit, and at the end of the study (EOS) on Day 105 for all participants (Arms A and B). The change in hearing threshold from baseline in the implanted ear was evaluated at 500 Hz and as an average across three frequencies (250, 500, and 750 Hz) using PTA.

Outcome measures

Outcome measures
Measure	A, Treatment Arm n=16 Participants Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm n=8 Participants Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies Day 49 : LS Mean change from baseline at 500Hz	19.7 dB Interval 11.1 to 28.2	30.6 dB Interval 18.5 to 42.8
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies Day 49 : LS Mean change from baseline at 250-750 Hz	16.25 dB Interval 7.92 to 24.59	30.65 dB Interval 18.42 to 42.88
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies Day 105: LS Mean change from baseline at 500 Hz	25.6 dB Interval 16.4 to 34.8	34.5 dB Interval 21.5 to 47.6
Change of Hearing Threshold From Baseline in the Implanted Ear at Several Frequencies Day 105: LS Mean change from baseline at 250-750 Hz	20.97 dB Interval 11.63 to 30.32	34.82 dB Interval 21.1 to 48.53

Adverse Events

A, Treatment Arm

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

B, Control Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A, Treatment Arm n=17 participants at risk Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm n=10 participants at risk Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Cardiac disorders Ventricular tachycardia	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Ear and labyrinth disorders Vertigo	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Injury, poisoning and procedural complications Ear procedural complication	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing

Other adverse events

Additional Information

Chief Medical Officer

Sensorion

Phone: +33 4 67 20 77 30

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI must in advance inform and provide to the sponsor a copy of the proposed publication. The sponsor may request that the PI remove confidential information from the publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	A, Treatment Arm n=17 participants at risk Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days. SENS-401 (R-Azasetron Besylate): Patients will receive SENS-401 ((R)-azasetron besylate) for 7 days B.I.D. before cochlear implant surgery and during 6 weeks after the surgery.	B, Control Arm n=10 participants at risk Arm B: Participants scheduled for cochlear implants and not treated with SENS-401 (R-Azasetron Besylate).
Gastrointestinal disorders Constipation	52.9% 9/17 • Number of events 9 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Gastrointestinal disorders Nausea	11.8% 2/17 • Number of events 2 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Gastrointestinal disorders Hypoaesthesia oral	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Gastrointestinal disorders Infrequent bowel movements	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Nervous system disorders Headache	17.6% 3/17 • Number of events 3 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Nervous system disorders Dysgeusia	11.8% 2/17 • Number of events 2 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	10.0% 1/10 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Ear and labyrinth disorders Ear pain	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Ear and labyrinth disorders Tinnitus	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Infections and infestations Laryngitis	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Metabolism and nutrition disorders Hypokalaemia	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Psychiatric disorders Insomnia	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Vascular disorders Hot flush	5.9% 1/17 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	0.00% 0/10 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Infections and infestations Ear infection	0.00% 0/17 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	10.0% 1/10 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing
Infections and infestations Skin infection	0.00% 0/17 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing	10.0% 1/10 • Number of events 1 • 105 days Adverse events were recorded for all study participants from the time of informed consent to study completion. For arm A other adverse events reported below areTreatment Emergent Adverse Events defined as follow: any untoward medical occurrence reported or observed after treatment administration. Safety assessments were performed at every site visit for all participants: regular investigator assessment and regular laboratory testing