Trial Outcomes & Findings for Effect of Semi-occluded Vocal Tract Therapy on the Phonation of Children With Vocal Fold Nodules (NCT NCT05878197)
NCT ID: NCT05878197
Last Updated: 2024-10-10
Results Overview
The dysphonia severity index (DSI) is a multiparametric score to quantify vocal capabilities. It is based on a weighted combination of 4 voice parameters: maximum phonation time (MPT, s), highest frequency (F-high, Hz), lowest intensity (I-low, dB) and jitter (%). The DSI is constructed as 0.13 MPT + 0.0053 F-high - 0.26 I-low - 1.18 jitter +12.4. The index ranges from -5 to +5. A score above +1.6 is considered normal. A higher score corresponds with better voice quality / vocal capacities.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Experimental Group 1 - Straw Phonation
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
8
|
|
Overall Study
COMPLETED
|
11
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group 1 - Straw Phonation
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
n=8 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
8 Participants
n=8 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
8.55 years
STANDARD_DEVIATION 2.2 • n=11 Participants
|
8.79 years
STANDARD_DEVIATION 1.5 • n=11 Participants
|
9.21 years
STANDARD_DEVIATION 1.9 • n=8 Participants
|
8.81 years
STANDARD_DEVIATION 1.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
16 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
8 Participants
n=8 Participants
|
30 Participants
n=30 Participants
|
|
Dysphonia Severity Index
|
-3.0 units on a scale
STANDARD_DEVIATION 3.3 • n=11 Participants
|
-2.6 units on a scale
STANDARD_DEVIATION 2.8 • n=11 Participants
|
-2.5 units on a scale
STANDARD_DEVIATION 3.2 • n=8 Participants
|
-2.7 units on a scale
STANDARD_DEVIATION 3.0 • n=30 Participants
|
|
Acoustic Voice Quality Index
|
4.16 units on a scale
STANDARD_DEVIATION 1.5 • n=11 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 1.4 • n=11 Participants
|
4.37 units on a scale
STANDARD_DEVIATION 1.2 • n=8 Participants
|
4.34 units on a scale
STANDARD_DEVIATION 1.4 • n=30 Participants
|
|
Pediatric Voice Handicap Index
|
20.73 units on a scale
STANDARD_DEVIATION 10.5 • n=11 Participants
|
27.90 units on a scale
STANDARD_DEVIATION 11.1 • n=11 Participants
|
23.50 units on a scale
STANDARD_DEVIATION 15.5 • n=8 Participants
|
23.97 units on a scale
STANDARD_DEVIATION 12.2 • n=30 Participants
|
|
Consensus Auditory-Percpetual Evaluation of Voice - Overall Severity
|
22.67 units on a scale
STANDARD_DEVIATION 15.9 • n=11 Participants
|
16.50 units on a scale
STANDARD_DEVIATION 5.1 • n=11 Participants
|
32.50 units on a scale
STANDARD_DEVIATION 0.7 • n=8 Participants
|
22.11 units on a scale
STANDARD_DEVIATION 10.8 • n=30 Participants
|
PRIMARY outcome
Timeframe: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4The dysphonia severity index (DSI) is a multiparametric score to quantify vocal capabilities. It is based on a weighted combination of 4 voice parameters: maximum phonation time (MPT, s), highest frequency (F-high, Hz), lowest intensity (I-low, dB) and jitter (%). The DSI is constructed as 0.13 MPT + 0.0053 F-high - 0.26 I-low - 1.18 jitter +12.4. The index ranges from -5 to +5. A score above +1.6 is considered normal. A higher score corresponds with better voice quality / vocal capacities.
Outcome measures
| Measure |
Experimental Group 1 - Straw Phonation
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
n=8 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
|---|---|---|---|
|
Change in Dysphonia Severity Index
|
1.8 units on a scale
Interval 0.1 to 3.4
|
1.8 units on a scale
Interval 0.1 to 3.4
|
0.0 units on a scale
Interval -1.9 to 1.9
|
PRIMARY outcome
Timeframe: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4Population: The audio samples of some participants were of insufficient quality to calculate the AVQI.
The acoustic voice quality index (AVQI) is a multiparametric score to quantify vocal quality. It is based on a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. A lower score correlates with a better vocal quality.
Outcome measures
| Measure |
Experimental Group 1 - Straw Phonation
n=8 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
n=4 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
n=5 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
|---|---|---|---|
|
Change in Acoustic Voice Quality Index
|
-0.1 units on a scale
Interval -0.6 to 0.4
|
-0.4 units on a scale
Interval -1.1 to 0.3
|
-0.3 units on a scale
Interval -0.9 to 0.3
|
PRIMARY outcome
Timeframe: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4The pediatric voice handicap index (pVHI) is a questionnaire to investigate children's voice-related quality of life, completed by the parents. The index ranges from 0 to 92. A higher score correlates with more psychosocial impact of the voice disorder.
Outcome measures
| Measure |
Experimental Group 1 - Straw Phonation
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
n=8 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
|---|---|---|---|
|
Change in Pediatric Voice Handicap Index (pVHI)
|
-3.3 score on a scale
Interval -7.2 to 0.7
|
-3.9 score on a scale
Interval -8.3 to 0.4
|
-1.7 score on a scale
Interval -6.7 to 3.2
|
PRIMARY outcome
Timeframe: pre: one day before therapy, day 0; post: immediately after last therapy session, day 4This tool is designed to describe the severity of dysphonia by rating six parameters (overall severity, roughness, breathiness, strain, pitch, and loudness) on a visual-analog scale from 0 to 100, where 0 is considered within normal limits. A higher score corresponds with worse voice quality.
Outcome measures
| Measure |
Experimental Group 1 - Straw Phonation
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): straw phonation and vocal hygiene recommendations
Straw phonation: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, straw phonation on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, straw phonation on word and sentence level, pitch variations Day 4: straw phonation in spontaneous speech, combination exercises
|
Experimental Group 2 - Resonant Voice Therapy
n=11 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): resonant voice therapy and vocal hygiene recommendations
Resonant voice therapy: The two experimental groups received either straw phonation therapy or resonant voice therapy. The hierarchical structure of the therapy sessions was equal for the three programs. In each session, vocal rest pauses were foreseen by playing games, performing drawing assignments, etc. This made the therapy more pleasant and less intensive. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations, resonant voice therapy on vowel and syllable level, pitch variations Day 3: breathing exercises, vocal hygiene recommendations, resonant voice therapy on word and sentence level, pitch variations Day 4: resonant voice therapy in spontaneous speech, combination exercises
|
Control Group
n=8 Participants
Short-term intensive voice therapy program of one week (3 hours a day for 4 consecutive days): vocal hygiene recommendations
Vocal Hygiene: Participants of the control group received a sham treatment, including the exact same games, drawing assignments, etc. as in the experimental groups. However, no SOVT or other active vocal techniques were practiced. Vocal hygiene guidelines (e.g. avoid screaming, imitating voices, sufficient hydration etc.) were kept equally in the three groups. All voice therapy programs were guided by the same experienced voice therapist.
Content:
Day 1: counseling (anatomy and physiology of the voice and vocal fold nodules), vocal hygiene recommendations (water intake, avoiding vocal misuse and abuse) Day 2: breathing exercises, vocal hygiene recommendations Day 3: breathing exercises, vocal hygiene recommendations Day 4: combination exercises
|
|---|---|---|---|
|
Change in Overall Severity From Consensus Auditory-Perceptual Evaluation of Voice
|
-6.5 score on a scale
Interval -12.2 to -0.9
|
-0.7 score on a scale
Interval -6.4 to 4.9
|
-1.0 score on a scale
Interval -7.7 to 5.7
|
Adverse Events
Experimental Group 1 - Straw Phonation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Group 2 - Resonant Voice Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place