Trial Outcomes & Findings for RHA®4 for Midface Volume Deficiency (NCT NCT05133739)
NCT ID: NCT05133739
Last Updated: 2025-03-18
Results Overview
A change in the TMVDS ≥1 grade compared to pretreatment will be considered clinically meaningful. In order to confirm sensitivity 8 weeks after the last treatment: the proportion of responders with a ≥1-grade point on the TMVDS scale for Comparator product 8 weeks after the last treatment when compared to Baseline must be ≥70%. The TMVDS is a validated 5-point scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
8 weeks after the last treatment
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
RHA®4
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
49
|
|
Overall Study
ITT Population
|
152
|
49
|
|
Overall Study
PP Population
|
131
|
42
|
|
Overall Study
COMPLETED
|
126
|
43
|
|
Overall Study
NOT COMPLETED
|
26
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RHA®4 for Midface Volume Deficiency
Baseline characteristics by cohort
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 7.85 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
49 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type I-III
|
107 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV-VI
|
45 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after the last treatmentPopulation: Primary endpoint on the PP population
A change in the TMVDS ≥1 grade compared to pretreatment will be considered clinically meaningful. In order to confirm sensitivity 8 weeks after the last treatment: the proportion of responders with a ≥1-grade point on the TMVDS scale for Comparator product 8 weeks after the last treatment when compared to Baseline must be ≥70%. The TMVDS is a validated 5-point scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
Outcome measures
| Measure |
RHA®4
n=131 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=42 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Non-inferiority of RHA®4 to the Change From Baseline for Subjects Treated With Comparator Product at 8 Weeks After the Last Treatment as Assessed by the BLE Using the Teoxane Midface Volume Deficit Scale (TMVDS).
|
-1.3 score on a scale
Standard Deviation 0.80
|
-1.3 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Week 24, 52 after last treatment, week 12 after re-treatmentPopulation: ITT Population
A change in the TMVDS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TMVDS is a validated 5-point static scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
Outcome measures
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Change From Baseline in TMVDS Score as Assessed by the BLE at 24 and 52 Weeks After Last Treatment,and Weeks After Re-treatment if Applicable.
Week 24 after last treatment
|
-1.1 score on a scale
Standard Deviation 0.79
|
-1.0 score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in TMVDS Score as Assessed by the BLE at 24 and 52 Weeks After Last Treatment,and Weeks After Re-treatment if Applicable.
Week 52 after last treatment
|
-0.9 score on a scale
Standard Deviation 0.79
|
-0.8 score on a scale
Standard Deviation 0.69
|
|
Change From Baseline in TMVDS Score as Assessed by the BLE at 24 and 52 Weeks After Last Treatment,and Weeks After Re-treatment if Applicable.
Re-treatment: 12 weeks post re-treatment
|
-1.1 score on a scale
Standard Deviation 0.91
|
-1.2 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Week 8, 24, 52 after last treatment, week 12 after re-treatmentPopulation: ITT Population
he Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
Outcome measures
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Week 8 after last treatment
|
129 Participants
|
44 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Week 24 after last treatment
|
111 Participants
|
37 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Week 52 after last treatment
|
97 Participants
|
30 Participants
|
|
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Re-treatment: 12 weeks post re-treatment
|
63 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline at Weeks 8, 24, 52 after last treatment,12 weeks after re-treatmentPopulation: ITT population
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied"). To calculate the FACE-Q score, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Outcome measures
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
Re-treatment: 12 weeks post re-treatment
|
50.8 score on a scale
Standard Deviation 29.97
|
59.3 score on a scale
Standard Deviation 21.76
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
Week 8 after last treatment
|
53.0 score on a scale
Standard Deviation 27.15
|
49.5 score on a scale
Standard Deviation 27.20
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
Week 24 after last treatment
|
48.0 score on a scale
Standard Deviation 27.65
|
52.5 score on a scale
Standard Deviation 23.48
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
Week 52 after last treatment
|
38.6 score on a scale
Standard Deviation 28.85
|
38.1 score on a scale
Standard Deviation 31.07
|
SECONDARY outcome
Timeframe: Change from Baseline at Weeks 8, 24, 52 after last treatment and 12 week after re-treatment.Population: ITT population
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied"). To calculate the FACE-Q score, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Outcome measures
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
Week 8 after last treatment
|
56.1 score on a scale
Standard Deviation 27.67
|
51.3 score on a scale
Standard Deviation 29.79
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
Week 24 after last treatment
|
49.5 score on a scale
Standard Deviation 29.33
|
53.2 score on a scale
Standard Deviation 26.68
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
Re-treatment: 12 weeks post re-treatment
|
53.1 score on a scale
Standard Deviation 28.43
|
58.2 score on a scale
Standard Deviation 21.87
|
|
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
Week 52 after last treatment
|
39.6 score on a scale
Standard Deviation 29.78
|
41.5 score on a scale
Standard Deviation 31.84
|
SECONDARY outcome
Timeframe: Week 8, 24, 52 after last treatment, week 12 after re-treatmentPopulation: ITT population
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
Outcome measures
| Measure |
RHA®4
n=152 Participants
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 Participants
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
Week 8 after last treatment
|
123 Participants
|
43 Participants
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
Week 24 after last treatment
|
119 Participants
|
39 Participants
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
Week 52 after last treatment
|
106 Participants
|
38 Participants
|
|
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
Re-treatment: 12 weeks post re-treatment
|
73 Participants
|
28 Participants
|
Adverse Events
RHA®4
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Comparator Device
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHA®4
n=152 participants at risk
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 participants at risk
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
Injury, poisoning and procedural complications
COMPLICATIONS FROM HERNIA REPAIR SURGERY
|
0.00%
0/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
2.0%
1/49 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Infections and infestations
COVID-19 INFECTION
|
0.66%
1/152 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACK
|
0.00%
0/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
2.0%
1/49 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
P16 POSITIVE OROPHARYNGEAL CANCER
|
0.00%
0/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
2.0%
1/49 • Number of events 1 • 52 to 64 (for patients receiving re-treatment) weeks
|
Other adverse events
| Measure |
RHA®4
n=152 participants at risk
injection of RHA®4 in Midface: RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
Comparator Device
n=49 participants at risk
injection of Comparator Product in Midface: Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
|
|---|---|---|
|
General disorders
Injection Site Mass
|
11.2%
17/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
6.1%
3/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
General disorders
Injection Site Induration
|
5.3%
8/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
10.2%
5/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
General disorders
Injection Site Pain
|
3.3%
5/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
2.0%
1/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
General disorders
Injection Site Discoloration
|
3.3%
5/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
0.00%
0/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Nervous system disorders
Headache
|
13.8%
21/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
10.2%
5/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Infections and infestations
Covid-19
|
5.9%
9/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
6.1%
3/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
3/152 • 52 to 64 (for patients receiving re-treatment) weeks
|
4.1%
2/49 • 52 to 64 (for patients receiving re-treatment) weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60