Trial Outcomes & Findings for Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial. (NCT NCT00104572)
NCT ID: NCT00104572
Last Updated: 2018-11-06
Results Overview
bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
1 year
Results posted on
2018-11-06
Participant Flow
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
Participant milestones
| Measure |
Transdermal Testosterone
13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
9 participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
9
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Transdermal Testosterone
13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
9 participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
Baseline Characteristics
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Baseline characteristics by cohort
| Measure |
Transdermal Testosterone
n=13 Participants
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=13 Participants
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=9 Participants
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
70 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
72 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
71 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
9 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Systolic blood pressure
|
137.8 mmHg
STANDARD_DEVIATION 9.4 • n=5 Participants
|
134.5 mmHg
STANDARD_DEVIATION 14.5 • n=7 Participants
|
133.7 mmHg
STANDARD_DEVIATION 11.2 • n=5 Participants
|
135.3 mmHg
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Diastolic blood pressure
|
73.3 mmHg
STANDARD_DEVIATION 5.3 • n=5 Participants
|
72.4 mmHg
STANDARD_DEVIATION 9.4 • n=7 Participants
|
73.1 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
72.9 mmHg
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
Body mass index
|
30.1 kg/m2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
27.8 kg/m2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Total Testosterone
|
300.1 ng/dL
STANDARD_DEVIATION 81.9 • n=5 Participants
|
271.6 ng/dL
STANDARD_DEVIATION 85.6 • n=7 Participants
|
303.8 ng/dL
STANDARD_DEVIATION 94.7 • n=5 Participants
|
291.8 ng/dL
STANDARD_DEVIATION 17.6 • n=4 Participants
|
|
Bioavailable Testosterone
|
114.4 ng/dL
STANDARD_DEVIATION 37.2 • n=5 Participants
|
114.8 ng/dL
STANDARD_DEVIATION 36.3 • n=7 Participants
|
91.2 ng/dL
STANDARD_DEVIATION 31.7 • n=5 Participants
|
106.8 ng/dL
STANDARD_DEVIATION 13.5 • n=4 Participants
|
|
Estradiol
|
2.0 ng/dL
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.5 ng/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.6 ng/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.700 ng/dL
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Sex hormone-binding globulin
|
43.4 nmol/L
STANDARD_DEVIATION 22.2 • n=5 Participants
|
39.9 nmol/L
STANDARD_DEVIATION 19.4 • n=7 Participants
|
58.6 nmol/L
STANDARD_DEVIATION 21.3 • n=5 Participants
|
47.30 nmol/L
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
luteinizing hormone
|
11.4 mlU/ml
STANDARD_DEVIATION 8.2 • n=5 Participants
|
6.4 mlU/ml
STANDARD_DEVIATION 2.7 • n=7 Participants
|
12.2 mlU/ml
STANDARD_DEVIATION 10.1 • n=5 Participants
|
10.00 mlU/ml
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
follicle-stimulating hormone
|
8.0 mlU/ml
STANDARD_DEVIATION 6.4 • n=5 Participants
|
6.5 mlU/ml
STANDARD_DEVIATION 5.3 • n=7 Participants
|
8.2 mlU/ml
STANDARD_DEVIATION 10.9 • n=5 Participants
|
7.567 mlU/ml
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Bone mineral density
|
1.4 g/cm2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.3 g/cm2
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.2 g/cm2
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.3 g/cm2
STANDARD_DEVIATION 0.1 • n=4 Participants
|
|
lean body mass
|
56.0 kg
STANDARD_DEVIATION 12 • n=5 Participants
|
54.7 kg
STANDARD_DEVIATION 11.0 • n=7 Participants
|
56.0 kg
STANDARD_DEVIATION 7.2 • n=5 Participants
|
55.6 kg
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Fat mass
|
31.6 kg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
26.9 kg
STANDARD_DEVIATION 9.6 • n=7 Participants
|
28.5 kg
STANDARD_DEVIATION 7.6 • n=5 Participants
|
29.0 kg
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
hand grip
|
41.1 kg
STANDARD_DEVIATION 6.9 • n=5 Participants
|
39.2 kg
STANDARD_DEVIATION 9.9 • n=7 Participants
|
39.3 kg
STANDARD_DEVIATION 7.2 • n=5 Participants
|
39.9 kg
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
knee strength
|
133.8 Nm
STANDARD_DEVIATION 44.3 • n=5 Participants
|
138.7 Nm
STANDARD_DEVIATION 48.6 • n=7 Participants
|
155.4 Nm
STANDARD_DEVIATION 41.9 • n=5 Participants
|
142.6 Nm
STANDARD_DEVIATION 11.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearbone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
Outcome measures
| Measure |
Transdermal Testosterone
n=13 Participants
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=13 Participants
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=9 Participants
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
|
0.042 g/cm2
Standard Deviation 0.008
|
0.008 g/cm2
Standard Deviation 0.012
|
0.047 g/cm2
Standard Deviation 0.013
|
SECONDARY outcome
Timeframe: 1 yearOvernight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo
Outcome measures
| Measure |
Transdermal Testosterone
n=13 Participants
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=13 Participants
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=9 Participants
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
|
5.8 ng/ml/8h
Standard Error 1.4
|
10 ng/ml/8h
Standard Error 2.2
|
7.7 ng/ml/8h
Standard Error 2.2
|
SECONDARY outcome
Timeframe: 1 yearPrimary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more. Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point.
Outcome measures
| Measure |
Transdermal Testosterone
n=10 Participants
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=10 Participants
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=9 Participants
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
|
-0.05 score on a scale
Standard Error 0.21
|
0.15 score on a scale
Standard Error 0.10
|
-0.11 score on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 1 yearrectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo. Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point.
Outcome measures
| Measure |
Transdermal Testosterone
n=10 Participants
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=10 Participants
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=9 Participants
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
|
4.5 cc
Standard Error 1.76
|
-1.66 cc
Standard Error 3.54
|
-1.05 cc
Standard Error 1.52
|
Adverse Events
Transdermal Testosterone
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Aromatase Inhibitor
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transdermal Testosterone
n=17 participants at risk
participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months
Androgel (Testosterone Gel): 1 mg tablet for 12 months
Placebo tablet: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Aromatase Inhibitor
n=14 participants at risk
participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months
Anastrozole (Aromatase Inhibitor)
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
Placebo
n=13 participants at risk
participants will receive a placebo tablet and placebo gel daily for 12 months
Placebo tablet: Daily for 12 months
Placebo gel: Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle ache
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.1%
1/14 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Renal and urinary disorders
bladder mass
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/14
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.7%
1/13 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Blood and lymphatic system disorders
subdural hematoma
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/14
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.7%
1/13 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Vascular disorders
stent placement
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/14
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.7%
1/13 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
5.9%
1/17 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/14
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Blood and lymphatic system disorders
mildly elevated HCT
|
5.9%
1/17 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/14
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Reproductive system and breast disorders
elevated PSA
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.1%
1/14 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Cardiac disorders
increased heart rate palpitations
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.1%
1/14 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
General disorders
dizziness/diarrhea
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.1%
1/14 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
|
Reproductive system and breast disorders
blood in semen
|
0.00%
0/17
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
7.1%
1/14 • Number of events 1
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
0.00%
0/13
The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place