Hypogonadism, Male
Conditions
Brief summary
The purpose of this six-month treatment study is * to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg \[200 mg with breakfast meal and 200mg with dinner meal\]) to titrate individual doses to further enhance efficacy and safety. * To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
Detailed description
This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019 (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT; NCT04467697), will extend the participation for up to 170 MRS-TU-2019 subjects and to new subjects, for a target of 135 evaluable subjects reaching the 4-month ABPM assessment. All subjects were washed out from previous testosterone therapy if they were not naïve. The study used ABPM monitoring to assess baseline and change from baseline after 120 and 180 days of treatment. The percentage of participants within the normal range for testosterone was assessed after two titration cycles and a total of 90 days of treatment.
Interventions
DRUGSOV2012-F1
Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU
Sponsors
Syneos Health
Marius Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
For all subjects participating in MRS-TU-2019EXT, whether rolling over from MRS-TU-2019 (after washout) or newly enrolling, the following MRS-TU-2019EXT Inclusion/
Exclusion criteria
apply: Inclusion Criteria: 1\. Completion of MRS-TU-2019 Day 365/ End of Treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | 120 days | Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis). |
| Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | 90 days | Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis. |
| Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly systolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly diastolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average diastolic blood pressure (dBP) after 120 Days (+/-) and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
| Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
| Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | 90 days | Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1. |
| Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 120 and 180 days | Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment. |
| Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | 120 and 180 days | Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average systolic blood pressure (sBP) after 120 and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis). |
Other
| Measure | Time frame | Description |
|---|---|---|
| AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | 180 days | Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects |
| Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Serum prostate-specific antigen (PSA) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of ng/mL. |
| Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Baseline, 90, 119 and 179 days | Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1. |
| Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Baseline, 90, 119 and 179 days | Measured by in-clinic HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1. |
| Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | 90 and 180 days | Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L) |
| Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | 90 and 180 days | Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL |
| Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL. |
| Observed and Change From Baseline in Hormone Levels. | 90 and 180 days | Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL. |
| Observed and Change From Baseline in Hormone Levels for SHBG. | 90 and 180 days | Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L. |
| Observed and Change From Baseline in Thyrotropin | 90 and 180 days | Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L. |
| Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | 90 and 180 days | Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOV2012-F1-treated Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths. | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | SOV2012-F1-treated |
|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 9.41 |
| Assigned breakfast diet High-fat breakfast | 80 Participants |
| Assigned breakfast diet Low-fat breakfast | 13 Participants |
| Assigned breakfast diet Missing | 9 Participants |
| Assigned breakfast diet Normal-fat breakfast | 53 Participants |
| Body Mass Index (BMI) | 33.95 kg/m^2 STANDARD_DEVIATION 7.343 |
| Diabetic Status With Diabetes Mellitus | 34 Participants |
| Diabetic Status Without Diabetes Mellitus | 121 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Hypertensive Status Hypertensive | 96 Participants |
| Hypertensive Status Missing | 3 Participants |
| Hypertensive Status Not hypertensive | 56 Participants |
| Hypertensive Treatment Status With Antihypertensive Therapy at Visit 7E (Day 1 E) | 56 Participants |
| Hypertensive Treatment Status Without Antihypertensive Therapy at Visit 7E (Day 1 E) | 99 Participants |
| Hypogonadal Status Primary | 8 Participants |
| Hypogonadal Status Secondary | 147 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 119 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 155 Participants |
| Weight at Baseline <= 93 kg | 59 Participants |
| Weight at Baseline > 93 kg | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 30 / 155 |
| serious Total, serious adverse events | 2 / 155 |
Outcome results
Primary
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).
Time frame: 120 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | Baseline | 128.9 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | Observed Visit 14E - Day 120E | 130.6 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment | Change from baseline (Visit 14E - Day 120E) | 1.7 mmHg |
Primary
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1.
Time frame: 90 days
Population: Modified Extension Treated Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOV2012-F1-treated | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | Worst case scenario | 87.8 percentage of participants |
| SOV2012-F1-treated | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | Day 90 completers | 96.1 percentage of participants |
| SERUM | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | Worst case scenario | 86.5 percentage of participants |
| SERUM | Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration | Day 90 completers | 87.5 percentage of participants |
Secondary
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average diastolic blood pressure (dBP) after 120 Days (+/-) and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis).
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | Baseline | 76.2 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | Observed Visit 14E (Day 120E) | 76.9 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | Change from Baseline to Visit 14E (Day 120E) | 0.6 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | Observed Visit 16E (Day 180E) | 76.9 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment. | Change from Baseline to Visit 16E (Day 180E) | 0.6 mmHg |
Secondary
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | Baseline | 76.3 bpm |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | Observed Visit 14E (Day 120E) | 77.0 bpm |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | Change from baseline to Visit 14E (Day 120E) | 0.7 bpm |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | Observed Visit 16E (Day 180E) | 78.2 bpm |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment. | Change from baseline to Visit 16E (Day 180E) | 1.9 bpm |
Secondary
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average systolic blood pressure (sBP) after 120 and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis).
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | Baseline | 128.9 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | Observed Visit 14E (Day 120E) | 130.6 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | Change from baseline (Day 120E - Day 1E) | 1.7 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | Observed Visit 16E (Day 180E) | 130.7 mmHg |
| SOV2012-F1-treated | Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment. | Change from baseline (Day 180E - Day 1E) | 1.8 mmHg |
Secondary
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
Observed and change from baseline in Ambulatory half hourly diastolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 81.1 mmHg | Standard Deviation 12.61 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 80.3 mmHg | Standard Deviation 13.11 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 78.1 mmHg | Standard Deviation 13.51 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 81.8 mmHg | Standard Deviation 11.05 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 81.0 mmHg | Standard Deviation 12.64 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 80.1 mmHg | Standard Deviation 12.22 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 80.3 mmHg | Standard Deviation 12.73 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 77.8 mmHg | Standard Deviation 12.39 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 70.3 mmHg | Standard Deviation 13.04 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 79.5 mmHg | Standard Deviation 13.48 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 78.5 mmHg | Standard Deviation 12.96 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 78.5 mmHg | Standard Deviation 12.89 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 79.5 mmHg | Standard Deviation 12.94 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 69.8 mmHg | Standard Deviation 13.04 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 69.6 mmHg | Standard Deviation 12.43 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 80.9 mmHg | Standard Deviation 12.37 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 80.6 mmHg | Standard Deviation 12.53 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 67.9 mmHg | Standard Deviation 11.62 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 67.6 mmHg | Standard Deviation 11.78 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 68.3 mmHg | Standard Deviation 11.82 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 81.2 mmHg | Standard Deviation 11.66 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 83.5 mmHg | Standard Deviation 11.71 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 67.7 mmHg | Standard Deviation 12.63 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 67.6 mmHg | Standard Deviation 11.91 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 67.2 mmHg | Standard Deviation 11.77 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 79.0 mmHg | Standard Deviation 11.54 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 83.7 mmHg | Standard Deviation 9.78 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 67.7 mmHg | Standard Deviation 12.71 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 68.3 mmHg | Standard Deviation 13.06 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 69.8 mmHg | Standard Deviation 13.53 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 78.9 mmHg | Standard Deviation 12.13 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 77.8 mmHg | Standard Deviation 13.39 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 70.7 mmHg | Standard Deviation 12.39 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 72.3 mmHg | Standard Deviation 12.97 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 73.1 mmHg | Standard Deviation 12.93 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 79.8 mmHg | Standard Deviation 12.56 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 74.9 mmHg | Standard Deviation 13.38 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 75.0 mmHg | Standard Deviation 12.23 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 75.1 mmHg | Standard Deviation 12.71 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 78.3 mmHg | Standard Deviation 13.37 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 79.1 mmHg | Standard Deviation 11.36 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 73.8 mmHg | Standard Deviation 13 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 77.6 mmHg | Standard Deviation 12.75 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 79.1 mmHg | Standard Deviation 12.48 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 79.2 mmHg | Standard Deviation 11.71 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 79.6 mmHg | Standard Deviation 12.55 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 81.7 mmHg | Standard Deviation 11.42 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 80.4 mmHg | Standard Deviation 12.48 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 80.5 mmHg | Standard Deviation 11.79 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 83.9 mmHg | Standard Deviation 10.09 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 82.2 mmHg | Standard Deviation 10.36 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 82.0 mmHg | Standard Deviation 11.1 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 80.8 mmHg | Standard Deviation 10.8 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 80.4 mmHg | Standard Deviation 12.83 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 79.4 mmHg | Standard Deviation 12.28 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 79.0 mmHg | Standard Deviation 12.82 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 79.9 mmHg | Standard Deviation 12.25 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 80.7 mmHg | Standard Deviation 11.87 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 79.3 mmHg | Standard Deviation 12.48 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 79.9 mmHg | Standard Deviation 12.15 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 80.9 mmHg | Standard Deviation 14.4 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 79.5 mmHg | Standard Deviation 12.27 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 78.8 mmHg | Standard Deviation 11.51 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 78.9 mmHg | Standard Deviation 11.75 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 79.5 mmHg | Standard Deviation 12.69 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 79.2 mmHg | Standard Deviation 11.24 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 80.3 mmHg | Standard Deviation 11.82 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 80.6 mmHg | Standard Deviation 12.26 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 80.4 mmHg | Standard Deviation 12.24 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 79.9 mmHg | Standard Deviation 12.02 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 80.0 mmHg | Standard Deviation 12.01 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 79.3 mmHg | Standard Deviation 11.81 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 79.8 mmHg | Standard Deviation 11.25 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 78.4 mmHg | Standard Deviation 11.9 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 76.9 mmHg | Standard Deviation 12.52 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 76.7 mmHg | Standard Deviation 13.26 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 74.4 mmHg | Standard Deviation 11.73 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 74.2 mmHg | Standard Deviation 12.82 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 72.5 mmHg | Standard Deviation 12.36 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 71.8 mmHg | Standard Deviation 12.22 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 70.5 mmHg | Standard Deviation 12.46 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 69.8 mmHg | Standard Deviation 11.2 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 69.1 mmHg | Standard Deviation 12.04 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 69.3 mmHg | Standard Deviation 12.42 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 68.9 mmHg | Standard Deviation 11.62 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 68.6 mmHg | Standard Deviation 11.46 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 68.3 mmHg | Standard Deviation 11.14 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 69.4 mmHg | Standard Deviation 12.85 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 68.5 mmHg | Standard Deviation 12.95 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 68.9 mmHg | Standard Deviation 12.56 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 70.8 mmHg | Standard Deviation 13.56 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 72.6 mmHg | Standard Deviation 14.23 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 74.3 mmHg | Standard Deviation 13.15 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 80.4 mmHg | Standard Deviation 13.33 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 79.3 mmHg | Standard Deviation 13.72 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 82.1 mmHg | Standard Deviation 12.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | -1.4 mmHg | Standard Deviation 15.16 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 1.6 mmHg | Standard Deviation 14.56 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | -0.4 mmHg | Standard Deviation 12.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 1.5 mmHg | Standard Deviation 13.41 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | -0.1 mmHg | Standard Deviation 14.34 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 0.6 mmHg | Standard Deviation 10.81 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 2.1 mmHg | Standard Deviation 14.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | -0.5 mmHg | Standard Deviation 12.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 0.7 mmHg | Standard Deviation 12.97 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | -0.8 mmHg | Standard Deviation 13.52 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | -1.0 mmHg | Standard Deviation 11.35 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 1.6 mmHg | Standard Deviation 16.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 0.4 mmHg | Standard Deviation 14.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 0.2 mmHg | Standard Deviation 13.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 1.2 mmHg | Standard Deviation 12.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 0.9 mmHg | Standard Deviation 13.79 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 1.5 mmHg | Standard Deviation 15.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 0.8 mmHg | Standard Deviation 12.8 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 0.4 mmHg | Standard Deviation 12.91 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 0.7 mmHg | Standard Deviation 15.36 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 3.6 mmHg | Standard Deviation 14.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 2.1 mmHg | Standard Deviation 13.03 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 1.9 mmHg | Standard Deviation 12.6 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 1.2 mmHg | Standard Deviation 14.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 1.8 mmHg | Standard Deviation 13.27 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | -0.3 mmHg | Standard Deviation 13.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 0.3 mmHg | Standard Deviation 12.69 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 3.3 mmHg | Standard Deviation 14.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | -0.0 mmHg | Standard Deviation 11.94 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 0.2 mmHg | Standard Deviation 13.96 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | -0.6 mmHg | Standard Deviation 12.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 0.3 mmHg | Standard Deviation 13.18 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 0.1 mmHg | Standard Deviation 15.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | -1.5 mmHg | Standard Deviation 13.63 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 2.4 mmHg | Standard Deviation 12.37 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 0.3 mmHg | Standard Deviation 12.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 0.1 mmHg | Standard Deviation 12.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | -0.2 mmHg | Standard Deviation 14.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 0.6 mmHg | Standard Deviation 12.6 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 1.9 mmHg | Standard Deviation 14.89 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 0.2 mmHg | Standard Deviation 12.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | -0.8 mmHg | Standard Deviation 14.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 0.1 mmHg | Standard Deviation 13.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | -0.0 mmHg | Standard Deviation 15.63 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 1.4 mmHg | Standard Deviation 14.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 0.6 mmHg | Standard Deviation 9.9 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | -1.3 mmHg | Standard Deviation 13.93 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 2.2 mmHg | Standard Deviation 13.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 82.9 mmHg | Standard Deviation 11.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 79.8 mmHg | Standard Deviation 11.99 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 79.3 mmHg | Standard Deviation 10.53 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 80.4 mmHg | Standard Deviation 12.45 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 79.8 mmHg | Standard Deviation 11.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 79.1 mmHg | Standard Deviation 12.6 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 79.2 mmHg | Standard Deviation 11.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 77.7 mmHg | Standard Deviation 12.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 74.8 mmHg | Standard Deviation 13.79 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 77.7 mmHg | Standard Deviation 12.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 77.5 mmHg | Standard Deviation 11.8 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 79.1 mmHg | Standard Deviation 11.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 82.9 mmHg | Standard Deviation 10.3 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 76.3 mmHg | Standard Deviation 12.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 80.6 mmHg | Standard Deviation 10.98 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 76.2 mmHg | Standard Deviation 11.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 74.0 mmHg | Standard Deviation 12.41 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 79.5 mmHg | Standard Deviation 11.6 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 76.2 mmHg | Standard Deviation 12.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 73.0 mmHg | Standard Deviation 11.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 74.3 mmHg | Standard Deviation 12.43 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 72.5 mmHg | Standard Deviation 13.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 80.2 mmHg | Standard Deviation 11.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 71.0 mmHg | Standard Deviation 11.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 69.9 mmHg | Standard Deviation 12.66 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 77.5 mmHg | Standard Deviation 12.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 69.6 mmHg | Standard Deviation 12.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 79.8 mmHg | Standard Deviation 10.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 69.0 mmHg | Standard Deviation 12.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 68.0 mmHg | Standard Deviation 12.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 68.4 mmHg | Standard Deviation 12.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 81.1 mmHg | Standard Deviation 10.97 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 69.2 mmHg | Standard Deviation 12.48 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 81.6 mmHg | Standard Deviation 12.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 68.9 mmHg | Standard Deviation 13.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 69.8 mmHg | Standard Deviation 12.88 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 83.3 mmHg | Standard Deviation 9.16 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 78.3 mmHg | Standard Deviation 11.47 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 69.9 mmHg | Standard Deviation 13.25 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 79.1 mmHg | Standard Deviation 12.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 78.9 mmHg | Standard Deviation 12.41 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 77.9 mmHg | Standard Deviation 11.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 79.2 mmHg | Standard Deviation 11.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 78.9 mmHg | Standard Deviation 11.1 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 78.3 mmHg | Standard Deviation 12.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 78.9 mmHg | Standard Deviation 10.52 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 72.8 mmHg | Standard Deviation 13.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 79.1 mmHg | Standard Deviation 11.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 1.2 mmHg | Standard Deviation 12.54 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 2.4 mmHg | Standard Deviation 13.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 0.2 mmHg | Standard Deviation 13.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 1.1 mmHg | Standard Deviation 14.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 0.5 mmHg | Standard Deviation 10.83 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 1.2 mmHg | Standard Deviation 12.89 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 1.4 mmHg | Standard Deviation 12.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 1.7 mmHg | Standard Deviation 12.87 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 0.6 mmHg | Standard Deviation 15.89 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 0.4 mmHg | Standard Deviation 14.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | -0.4 mmHg | Standard Deviation 13.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 0.5 mmHg | Standard Deviation 14.85 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | -0.7 mmHg | Standard Deviation 12.71 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 1.5 mmHg | Standard Deviation 14.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 2.3 mmHg | Standard Deviation 13.55 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 1.9 mmHg | Standard Deviation 14.26 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | -0.5 mmHg | Standard Deviation 13.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 1.5 mmHg | Standard Deviation 13.31 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | -0.5 mmHg | Standard Deviation 12.65 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | -0.3 mmHg | Standard Deviation 13.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | -0.2 mmHg | Standard Deviation 11.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 1.3 mmHg | Standard Deviation 14.39 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | -1.6 mmHg | Standard Deviation 13.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | -0.2 mmHg | Standard Deviation 13.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 1.0 mmHg | Standard Deviation 15.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | -0.5 mmHg | Standard Deviation 13.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | -0.0 mmHg | Standard Deviation 12.29 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 0.3 mmHg | Standard Deviation 12.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 2.6 mmHg | Standard Deviation 14.27 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | -0.2 mmHg | Standard Deviation 12.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 2.3 mmHg | Standard Deviation 11.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 2.4 mmHg | Standard Deviation 15.69 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 0.1 mmHg | Standard Deviation 14.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 0.8 mmHg | Standard Deviation 13.16 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 1.9 mmHg | Standard Deviation 13.87 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 0.1 mmHg | Standard Deviation 9.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | -0.3 mmHg | Standard Deviation 11.3 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | -0.8 mmHg | Standard Deviation 12.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 0.5 mmHg | Standard Deviation 14.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 1.2 mmHg | Standard Deviation 12.32 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | -0.6 mmHg | Standard Deviation 12.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 2.3 mmHg | Standard Deviation 15.89 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 0.2 mmHg | Standard Deviation 12.21 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 0.7 mmHg | Standard Deviation 12.81 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | -0.0 mmHg | Standard Deviation 12.66 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 1.6 mmHg | Standard Deviation 13.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 3.8 mmHg | Standard Deviation 13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 0.9 mmHg | Standard Deviation 12.21 |
Secondary
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6 hours | 79.3 bpm | Standard Deviation 14.41 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0.5 hours | 76.0 bpm | Standard Deviation 12.94 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1 hour | 77.7 bpm | Standard Deviation 15.77 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1.5 hours | 79.9 bpm | Standard Deviation 12.93 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2 hours | 80.7 bpm | Standard Deviation 15.79 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2.5 hours | 79.4 bpm | Standard Deviation 14.63 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3 hours | 79.0 bpm | Standard Deviation 13.08 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3.5 hours | 79.3 bpm | Standard Deviation 15.29 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4 hours | 78.4 bpm | Standard Deviation 14.73 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4.5 hours | 79.1 bpm | Standard Deviation 15.18 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5 hours | 79.0 bpm | Standard Deviation 15.42 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5.5 hours | 78.5 bpm | Standard Deviation 14.56 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0 hours | 72.6 bpm | Standard Deviation 10.22 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6.5 hours | 79.2 bpm | Standard Deviation 15.03 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7 hours | 80.6 bpm | Standard Deviation 15.04 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7.5 hours | 80.0 bpm | Standard Deviation 14.51 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8 hours | 81.5 bpm | Standard Deviation 14.63 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8.5 hours | 80.0 bpm | Standard Deviation 14.09 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9 hours | 80.1 bpm | Standard Deviation 13.86 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9.5 hours | 79.9 bpm | Standard Deviation 14.21 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10 hours | 81.8 bpm | Standard Deviation 16.28 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10.5 hours | 80.4 bpm | Standard Deviation 14.75 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11 hours | 79.9 bpm | Standard Deviation 14.07 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11.5 hours | 79.8 bpm | Standard Deviation 14.31 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12 hours | 79.5 bpm | Standard Deviation 13.8 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12.5 hours | 78.8 bpm | Standard Deviation 13.66 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13 hours | 76.4 bpm | Standard Deviation 12.04 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13.5 hours | 75.8 bpm | Standard Deviation 12.05 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14 hours | 75.6 bpm | Standard Deviation 12.47 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14.5 hours | 73.3 bpm | Standard Deviation 12.74 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15 hours | 72.5 bpm | Standard Deviation 11.47 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15.5 hours | 72.0 bpm | Standard Deviation 12.06 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16 hours | 70.8 bpm | Standard Deviation 12.21 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16.5 hours | 69.5 bpm | Standard Deviation 10.97 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17 hours | 69.7 bpm | Standard Deviation 12.03 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17.5 hours | 69.5 bpm | Standard Deviation 10.94 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18 hours | 68.2 bpm | Standard Deviation 11.4 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18.5 hours | 68.4 bpm | Standard Deviation 11.24 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19 hours | 67.4 bpm | Standard Deviation 10.88 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19.5 hours | 67.1 bpm | Standard Deviation 11.1 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20 hours | 68.5 bpm | Standard Deviation 11.67 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20.5 hours | 68.5 bpm | Standard Deviation 12.28 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21 hours | 69.0 bpm | Standard Deviation 11.22 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21.5 hours | 69.9 bpm | Standard Deviation 13.57 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22 hours | 71.3 bpm | Standard Deviation 15.14 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22.5 hours | 73.6 bpm | Standard Deviation 12.08 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23 hours | 75.9 bpm | Standard Deviation 16.45 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23.5 hours | 74.2 bpm | Standard Deviation 11.67 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9.5 hours | 80.1 bpm | Standard Deviation 16.09 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2.5 hours | 80.3 bpm | Standard Deviation 14.6 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23.5 hours | 77.8 bpm | Standard Deviation 13.99 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13.5 hours | 77.6 bpm | Standard Deviation 13.9 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2 hours | 80.8 bpm | Standard Deviation 13.53 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10 hours | 80.6 bpm | Standard Deviation 15.75 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6 hours | 80.5 bpm | Standard Deviation 13.26 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13 hours | 77.6 bpm | Standard Deviation 13.23 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12.5 hours | 79.1 bpm | Standard Deviation 15.12 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12 hours | 79.3 bpm | Standard Deviation 15.02 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10.5 hours | 78.4 bpm | Standard Deviation 13.73 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4.5 hours | 79.2 bpm | Standard Deviation 13.65 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21.5 hours | 68.2 bpm | Standard Deviation 11.52 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11.5 hours | 79.4 bpm | Standard Deviation 14.58 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11 hours | 80.5 bpm | Standard Deviation 15.79 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19.5 hours | 67.4 bpm | Standard Deviation 11.15 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1.5 hours | 80.8 bpm | Standard Deviation 16.36 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23 hours | 74.5 bpm | Standard Deviation 13.07 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6.5 hours | 80.1 bpm | Standard Deviation 14.4 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20 hours | 66.8 bpm | Standard Deviation 10.85 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1 hour | 80.4 bpm | Standard Deviation 13.03 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0.5 hours | 77.6 bpm | Standard Deviation 12.7 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20.5 hours | 67.3 bpm | Standard Deviation 11.7 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7 hours | 80.9 bpm | Standard Deviation 13.85 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0 hours | 74.5 bpm | Standard Deviation 10.15 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19 hours | 67.6 bpm | Standard Deviation 10.68 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18.5 hours | 68.4 bpm | Standard Deviation 11.23 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4 hours | 79.7 bpm | Standard Deviation 14.59 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7.5 hours | 79.5 bpm | Standard Deviation 13.66 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3.5 hours | 80.1 bpm | Standard Deviation 13.81 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18 hours | 68.7 bpm | Standard Deviation 10.61 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17.5 hours | 69.9 bpm | Standard Deviation 11.53 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17 hours | 70.5 bpm | Standard Deviation 11.83 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8 hours | 80.8 bpm | Standard Deviation 14.18 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5.5 hours | 80.6 bpm | Standard Deviation 13.19 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22.5 hours | 75.0 bpm | Standard Deviation 15.82 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16.5 hours | 71.0 bpm | Standard Deviation 11.59 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16 hours | 71.9 bpm | Standard Deviation 12.01 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8.5 hours | 79.9 bpm | Standard Deviation 14.41 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5 hours | 80.5 bpm | Standard Deviation 14.79 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15.5 hours | 73.3 bpm | Standard Deviation 12.41 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15 hours | 74.5 bpm | Standard Deviation 12.37 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14.5 hours | 75.5 bpm | Standard Deviation 12.8 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9 hours | 80.9 bpm | Standard Deviation 14.06 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3 hours | 79.5 bpm | Standard Deviation 13.15 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22 hours | 70.4 bpm | Standard Deviation 13.8 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14 hours | 75.5 bpm | Standard Deviation 13.44 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21 hours | 68.1 bpm | Standard Deviation 12.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7 hours | 0.8 bpm | Standard Deviation 14.83 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20 hours | -1.2 bpm | Standard Deviation 11.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5 hours | 1.2 bpm | Standard Deviation 16.09 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5.5 hours | 1.9 bpm | Standard Deviation 15.36 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6 hours | 1.2 bpm | Standard Deviation 15.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6.5 hours | 1.5 bpm | Standard Deviation 14.9 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20.5 hours | -0.8 bpm | Standard Deviation 13.57 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7.5 hours | -0.3 bpm | Standard Deviation 15.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8 hours | -0.9 bpm | Standard Deviation 15.86 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8.5 hours | -0.1 bpm | Standard Deviation 13.89 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9 hours | 0.2 bpm | Standard Deviation 14.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9.5 hours | -0.1 bpm | Standard Deviation 14.18 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21 hours | -0.6 bpm | Standard Deviation 13.25 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10 hours | -1.0 bpm | Standard Deviation 15.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10.5 hours | -2.2 bpm | Standard Deviation 13.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11 hours | 0.3 bpm | Standard Deviation 14.52 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11.5 hours | -1.0 bpm | Standard Deviation 16.26 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12 hours | -0.5 bpm | Standard Deviation 15.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21.5 hours | -1.4 bpm | Standard Deviation 14.26 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12.5 hours | 0.7 bpm | Standard Deviation 15.81 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13 hours | 1.7 bpm | Standard Deviation 13.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13.5 hours | 2.3 bpm | Standard Deviation 14.01 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14 hours | 0.1 bpm | Standard Deviation 13.93 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14.5 hours | 2.0 bpm | Standard Deviation 13.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22 hours | -0.6 bpm | Standard Deviation 16.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15 hours | 2.0 bpm | Standard Deviation 13.02 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15.5 hours | 1.1 bpm | Standard Deviation 12.61 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16 hours | 1.0 bpm | Standard Deviation 11.48 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23.5 hours | 3.2 bpm | Standard Deviation 14.69 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16.5 hours | 1.8 bpm | Standard Deviation 12.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17 hours | 0.8 bpm | Standard Deviation 11.6 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22.5 hours | 2.2 bpm | Standard Deviation 16.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17.5 hours | 0.5 bpm | Standard Deviation 12.57 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18 hours | 0.5 bpm | Standard Deviation 11.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18.5 hours | 0.2 bpm | Standard Deviation 10.66 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19 hours | 0.4 bpm | Standard Deviation 10.56 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0 hours | 2.3 bpm | Standard Deviation 9.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0.5 hours | 0.5 bpm | Standard Deviation 11.06 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1 hour | 2.4 bpm | Standard Deviation 16.11 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1.5 hours | 1.4 bpm | Standard Deviation 16.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2 hours | 0.8 bpm | Standard Deviation 16.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19.5 hours | 0.9 bpm | Standard Deviation 11.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2.5 hours | 0.7 bpm | Standard Deviation 15.94 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3 hours | 0.2 bpm | Standard Deviation 14.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3.5 hours | 0.4 bpm | Standard Deviation 18.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23 hours | 1.2 bpm | Standard Deviation 12.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4 hours | 1.1 bpm | Standard Deviation 15.37 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4.5 hours | 0.4 bpm | Standard Deviation 16.29 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14 hours | 75.9 bpm | Standard Deviation 13.63 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9 hours | 82.2 bpm | Standard Deviation 13.93 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2 hours | 82.9 bpm | Standard Deviation 15.78 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14.5 hours | 75.1 bpm | Standard Deviation 13.76 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15 hours | 74.3 bpm | Standard Deviation 13.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22 hours | 73.0 bpm | Standard Deviation 14.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8.5 hours | 79.9 bpm | Standard Deviation 13.34 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15.5 hours | 72.9 bpm | Standard Deviation 12.71 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16 hours | 72.6 bpm | Standard Deviation 12.32 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2.5 hours | 82.8 bpm | Standard Deviation 15.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16.5 hours | 72.0 bpm | Standard Deviation 13.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8 hours | 80.8 bpm | Standard Deviation 14.34 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20.5 hours | 68.4 bpm | Standard Deviation 12.36 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19.5 hours | 69.8 bpm | Standard Deviation 12.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17 hours | 70.2 bpm | Standard Deviation 13.07 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5.5 hours | 81.0 bpm | Standard Deviation 16.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4 hours | 80.1 bpm | Standard Deviation 16.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17.5 hours | 70.3 bpm | Standard Deviation 13.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22.5 hours | 75.3 bpm | Standard Deviation 16.29 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7.5 hours | 81.1 bpm | Standard Deviation 14.52 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3 hours | 80.3 bpm | Standard Deviation 15.85 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18 hours | 69.4 bpm | Standard Deviation 12.94 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18.5 hours | 69.5 bpm | Standard Deviation 13.1 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23.5 hours | 79.6 bpm | Standard Deviation 17.4 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7 hours | 79.8 bpm | Standard Deviation 13.27 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4.5 hours | 79.9 bpm | Standard Deviation 15.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20 hours | 67.7 bpm | Standard Deviation 12.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0 hours | 74.5 bpm | Standard Deviation 11.63 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19 hours | 69.2 bpm | Standard Deviation 13.04 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0.5 hours | 78.1 bpm | Standard Deviation 14.86 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6.5 hours | 80.4 bpm | Standard Deviation 13.94 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3.5 hours | 79.9 bpm | Standard Deviation 16.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1 hour | 81.1 bpm | Standard Deviation 16.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23 hours | 75.9 bpm | Standard Deviation 13.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11 hours | 80.8 bpm | Standard Deviation 13.14 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11.5 hours | 80.2 bpm | Standard Deviation 15.05 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10.5 hours | 80.7 bpm | Standard Deviation 13.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21 hours | 68.8 bpm | Standard Deviation 12.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12 hours | 79.8 bpm | Standard Deviation 14.57 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1.5 hours | 83.1 bpm | Standard Deviation 14.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12.5 hours | 78.9 bpm | Standard Deviation 14.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21.5 hours | 71.6 bpm | Standard Deviation 13.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10 hours | 82.1 bpm | Standard Deviation 14.95 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6 hours | 80.4 bpm | Standard Deviation 14.02 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13 hours | 77.8 bpm | Standard Deviation 14.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13.5 hours | 78.1 bpm | Standard Deviation 15.15 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9.5 hours | 81.8 bpm | Standard Deviation 13.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5 hours | 79.7 bpm | Standard Deviation 15.39 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19.5 hours | 2.7 bpm | Standard Deviation 12.47 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14 hours | 1.0 bpm | Standard Deviation 13.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23 hours | 1.8 bpm | Standard Deviation 12.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3.5 hours | 2.3 bpm | Standard Deviation 18.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13 hours | 2.3 bpm | Standard Deviation 14.37 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 14.5 hours | 2.3 bpm | Standard Deviation 14.03 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2 hours | 3.6 bpm | Standard Deviation 16.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8.5 hours | 0.6 bpm | Standard Deviation 14.18 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5 hours | 2.9 bpm | Standard Deviation 14.93 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0 hours | 3.0 bpm | Standard Deviation 10.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15 hours | 2.3 bpm | Standard Deviation 11.29 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12 hours | 1.2 bpm | Standard Deviation 13.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6.5 hours | 3.2 bpm | Standard Deviation 15.91 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 5.5 hours | 4.0 bpm | Standard Deviation 16.48 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4 hours | 2.8 bpm | Standard Deviation 18.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 15.5 hours | 1.1 bpm | Standard Deviation 12.61 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22 hours | 3.1 bpm | Standard Deviation 14.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20.5 hours | 0.0 bpm | Standard Deviation 12.43 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 4.5 hours | 3.0 bpm | Standard Deviation 16.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21.5 hours | 1.4 bpm | Standard Deviation 13.83 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16 hours | 1.7 bpm | Standard Deviation 12.4 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 0.5 hours | 3.4 bpm | Standard Deviation 14.24 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 8 hours | 0.5 bpm | Standard Deviation 15.15 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 2.5 hours | 4.4 bpm | Standard Deviation 15.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 19 hours | 2.1 bpm | Standard Deviation 11.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 16.5 hours | 2.5 bpm | Standard Deviation 12.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10 hours | 1.1 bpm | Standard Deviation 16.53 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1.5 hours | 3.6 bpm | Standard Deviation 15.81 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9.5 hours | 2.1 bpm | Standard Deviation 16.58 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 1 hour | 4.5 bpm | Standard Deviation 18.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17 hours | 0.8 bpm | Standard Deviation 12.09 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 21 hours | -0.2 bpm | Standard Deviation 12.68 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7.5 hours | 2.4 bpm | Standard Deviation 14.98 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 12.5 hours | 0.8 bpm | Standard Deviation 13.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 20 hours | -0.4 bpm | Standard Deviation 13.55 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 17.5 hours | 0.4 bpm | Standard Deviation 13.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11 hours | 2.0 bpm | Standard Deviation 13.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 23.5 hours | 3.7 bpm | Standard Deviation 12.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 10.5 hours | 1.2 bpm | Standard Deviation 15.3 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 6 hours | 2.9 bpm | Standard Deviation 15.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18 hours | 1.4 bpm | Standard Deviation 12.65 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 22.5 hours | 3.1 bpm | Standard Deviation 14.8 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 7 hours | 0.6 bpm | Standard Deviation 15.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 3 hours | 2.7 bpm | Standard Deviation 14.96 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 9 hours | 2.5 bpm | Standard Deviation 15.45 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 18.5 hours | 1.4 bpm | Standard Deviation 13.11 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 11.5 hours | 0.9 bpm | Standard Deviation 14.64 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment. | 13.5 hours | 3.7 bpm | Standard Deviation 14.77 |
Secondary
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
Observed and change from baseline in Ambulatory half hourly systolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Time frame: 120 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 130.9 mmHg | Standard Deviation 16.68 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 135.6 mmHg | Standard Deviation 15.23 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 133.9 mmHg | Standard Deviation 15.28 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 132.3 mmHg | Standard Deviation 15.32 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 131.9 mmHg | Standard Deviation 15.6 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 130.9 mmHg | Standard Deviation 15.29 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 130.9 mmHg | Standard Deviation 15.84 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 130.6 mmHg | Standard Deviation 15.54 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 130.7 mmHg | Standard Deviation 14.42 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 130.5 mmHg | Standard Deviation 15.73 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 129.3 mmHg | Standard Deviation 15.69 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 130.8 mmHg | Standard Deviation 16.2 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 133.3 mmHg | Standard Deviation 12.02 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 131.2 mmHg | Standard Deviation 17.44 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 131.8 mmHg | Standard Deviation 16.52 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 131.5 mmHg | Standard Deviation 17.07 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 132.6 mmHg | Standard Deviation 15.63 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 133.6 mmHg | Standard Deviation 15.24 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 133.7 mmHg | Standard Deviation 15.37 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 133.0 mmHg | Standard Deviation 16.47 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 132.5 mmHg | Standard Deviation 16.52 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 133.3 mmHg | Standard Deviation 16.54 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 132.1 mmHg | Standard Deviation 15.55 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 131.4 mmHg | Standard Deviation 15.99 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 129.8 mmHg | Standard Deviation 15.25 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 129.5 mmHg | Standard Deviation 15.29 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 126.9 mmHg | Standard Deviation 16.11 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 126.7 mmHg | Standard Deviation 15.55 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 125.1 mmHg | Standard Deviation 16.69 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 123.7 mmHg | Standard Deviation 16.27 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 122.4 mmHg | Standard Deviation 15.78 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 121.1 mmHg | Standard Deviation 16.98 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 119.2 mmHg | Standard Deviation 16.09 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 116.8 mmHg | Standard Deviation 16.02 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 116.9 mmHg | Standard Deviation 15.07 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 117.4 mmHg | Standard Deviation 15.03 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 116.4 mmHg | Standard Deviation 15.44 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 117.7 mmHg | Standard Deviation 15.18 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 116.1 mmHg | Standard Deviation 14.22 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 116.5 mmHg | Standard Deviation 15.54 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 117.4 mmHg | Standard Deviation 16.25 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 118.2 mmHg | Standard Deviation 16.81 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 118.4 mmHg | Standard Deviation 15.85 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 123.0 mmHg | Standard Deviation 15.13 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 123.8 mmHg | Standard Deviation 16.88 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 127.1 mmHg | Standard Deviation 17.61 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 129.1 mmHg | Standard Deviation 16.44 |
| SOV2012-F1-treated | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 131.0 mmHg | Standard Deviation 13.83 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 134.7 mmHg | Standard Deviation 15.24 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 132.6 mmHg | Standard Deviation 15.86 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 130.4 mmHg | Standard Deviation 13.41 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 130.1 mmHg | Standard Deviation 17.21 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 132.7 mmHg | Standard Deviation 14.17 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 133.6 mmHg | Standard Deviation 15.09 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 133.2 mmHg | Standard Deviation 14.86 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 131.4 mmHg | Standard Deviation 16.17 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 131.4 mmHg | Standard Deviation 15.81 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 132.6 mmHg | Standard Deviation 15.45 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 134.9 mmHg | Standard Deviation 17.51 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 131.5 mmHg | Standard Deviation 15.78 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 121.8 mmHg | Standard Deviation 16.57 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 133.5 mmHg | Standard Deviation 14.61 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 134.9 mmHg | Standard Deviation 15.43 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 118.5 mmHg | Standard Deviation 15.24 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 132.8 mmHg | Standard Deviation 13.76 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 129.4 mmHg | Standard Deviation 15.25 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 132.4 mmHg | Standard Deviation 15.72 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 117.7 mmHg | Standard Deviation 16.48 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 133.9 mmHg | Standard Deviation 13.53 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 134.2 mmHg | Standard Deviation 13.87 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 117.9 mmHg | Standard Deviation 16.29 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 133.0 mmHg | Standard Deviation 16.16 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 133.7 mmHg | Standard Deviation 12.9 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 117.2 mmHg | Standard Deviation 15.37 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 117.4 mmHg | Standard Deviation 16.31 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 133.2 mmHg | Standard Deviation 15.35 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 133.3 mmHg | Standard Deviation 15.53 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 131.5 mmHg | Standard Deviation 16.28 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 118.0 mmHg | Standard Deviation 16.12 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 118.4 mmHg | Standard Deviation 16 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 118.4 mmHg | Standard Deviation 16.39 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 132.3 mmHg | Standard Deviation 13.22 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 133.8 mmHg | Standard Deviation 16.34 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 129.5 mmHg | Standard Deviation 15.39 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 120.5 mmHg | Standard Deviation 16.58 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 122.0 mmHg | Standard Deviation 15.24 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 133.7 mmHg | Standard Deviation 14.74 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 133.5 mmHg | Standard Deviation 16.69 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 124.2 mmHg | Standard Deviation 16.92 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 125.7 mmHg | Standard Deviation 16.48 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 127.2 mmHg | Standard Deviation 16.38 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 134.0 mmHg | Standard Deviation 15.99 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 131.2 mmHg | Standard Deviation 15.86 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 124.1 mmHg | Standard Deviation 15.37 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 127.8 mmHg | Standard Deviation 15.68 |
| SERUM | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 120.7 mmHg | Standard Deviation 16.36 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 1.3 mmHg | Standard Deviation 17.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 0.6 mmHg | Standard Deviation 16.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 4.8 mmHg | Standard Deviation 17.57 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 3.4 mmHg | Standard Deviation 18.06 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 3.2 mmHg | Standard Deviation 16.16 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 2.1 mmHg | Standard Deviation 19.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 0.4 mmHg | Standard Deviation 18.78 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 1.6 mmHg | Standard Deviation 17.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | -0.8 mmHg | Standard Deviation 16.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 0.7 mmHg | Standard Deviation 16.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 0.6 mmHg | Standard Deviation 16.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 1.5 mmHg | Standard Deviation 17.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 1.7 mmHg | Standard Deviation 19.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 1.4 mmHg | Standard Deviation 17.78 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 1.5 mmHg | Standard Deviation 18.15 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 2.6 mmHg | Standard Deviation 16.27 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 1.9 mmHg | Standard Deviation 16.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 2.7 mmHg | Standard Deviation 16.85 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | -1.1 mmHg | Standard Deviation 17.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 2.4 mmHg | Standard Deviation 18.09 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 5.3 mmHg | Standard Deviation 17.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 3.3 mmHg | Standard Deviation 18.8 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 2.9 mmHg | Standard Deviation 18.06 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 3.2 mmHg | Standard Deviation 17.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 0.9 mmHg | Standard Deviation 18.73 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 3.5 mmHg | Standard Deviation 18.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 3.1 mmHg | Standard Deviation 18.83 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 2.3 mmHg | Standard Deviation 17.88 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | -0.9 mmHg | Standard Deviation 13.66 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 3.9 mmHg | Standard Deviation 16.94 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 1.0 mmHg | Standard Deviation 17.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 3.3 mmHg | Standard Deviation 17.35 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 0.5 mmHg | Standard Deviation 16.84 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 1.3 mmHg | Standard Deviation 17.87 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 0.1 mmHg | Standard Deviation 16.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 1.1 mmHg | Standard Deviation 16.02 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 0.7 mmHg | Standard Deviation 13.9 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | -0.6 mmHg | Standard Deviation 13.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 0.4 mmHg | Standard Deviation 15.54 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 0.9 mmHg | Standard Deviation 14.8 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 1.9 mmHg | Standard Deviation 16.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 2.4 mmHg | Standard Deviation 16.4 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 1.8 mmHg | Standard Deviation 16.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 1.0 mmHg | Standard Deviation 18.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 1.0 mmHg | Standard Deviation 18.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 0.4 mmHg | Standard Deviation 17.41 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 2.2 mmHg | Standard Deviation 14.82 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 1.0 mmHg | Standard Deviation 15.69 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 128.0 mmHg | Standard Deviation 16.68 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | 131.4 mmHg | Standard Deviation 14.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 132.6 mmHg | Standard Deviation 15.87 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 126.7 mmHg | Standard Deviation 16.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 127.1 mmHg | Standard Deviation 17.74 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 126.0 mmHg | Standard Deviation 15.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | 131.2 mmHg | Standard Deviation 13.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 125.4 mmHg | Standard Deviation 18.38 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 123.4 mmHg | Standard Deviation 14.4 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 132.5 mmHg | Standard Deviation 14.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 121.4 mmHg | Standard Deviation 14.99 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | 131.9 mmHg | Standard Deviation 13.98 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 120.2 mmHg | Standard Deviation 17.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 117.9 mmHg | Standard Deviation 16.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 120.7 mmHg | Standard Deviation 16.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 132.4 mmHg | Standard Deviation 16.83 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 131.9 mmHg | Standard Deviation 15.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 119.8 mmHg | Standard Deviation 16.35 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 128.3 mmHg | Standard Deviation 16.56 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 132.2 mmHg | Standard Deviation 13.53 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 132.2 mmHg | Standard Deviation 14.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 118.6 mmHg | Standard Deviation 15.26 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 118.5 mmHg | Standard Deviation 15.02 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 131.6 mmHg | Standard Deviation 14.62 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | 129.7 mmHg | Standard Deviation 15.41 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 132.4 mmHg | Standard Deviation 14.7 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 119.0 mmHg | Standard Deviation 15.33 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | 133.1 mmHg | Standard Deviation 11.95 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 118.1 mmHg | Standard Deviation 16.61 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | 133.1 mmHg | Standard Deviation 12.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 131.4 mmHg | Standard Deviation 16.31 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 131.5 mmHg | Standard Deviation 16.53 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 135.5 mmHg | Standard Deviation 13.07 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 132.6 mmHg | Standard Deviation 15.73 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 132.0 mmHg | Standard Deviation 13.45 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 132.7 mmHg | Standard Deviation 14.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | 133.0 mmHg | Standard Deviation 13.51 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 121.2 mmHg | Standard Deviation 16.42 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 131.7 mmHg | Standard Deviation 14.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 133.5 mmHg | Standard Deviation 13.75 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 131.7 mmHg | Standard Deviation 14.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 124.7 mmHg | Standard Deviation 16.86 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 134.2 mmHg | Standard Deviation 15.35 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 132.2 mmHg | Standard Deviation 16.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 130.9 mmHg | Standard Deviation 16.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 131.0 mmHg | Standard Deviation 16.29 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | 131.8 mmHg | Standard Deviation 15.67 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 130.8 mmHg | Standard Deviation 15.98 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19.5 hours | 2.0 mmHg | Standard Deviation 16.59 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14 hours | 2.8 mmHg | Standard Deviation 20.12 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23 hours | 4.8 mmHg | Standard Deviation 16.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3.5 hours | 2.0 mmHg | Standard Deviation 17.44 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13 hours | 5.3 mmHg | Standard Deviation 18.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 14.5 hours | 3.4 mmHg | Standard Deviation 19.46 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2 hours | 1.7 mmHg | Standard Deviation 18.07 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8.5 hours | -1.4 mmHg | Standard Deviation 14.26 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5 hours | 2.2 mmHg | Standard Deviation 16.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0 hours | -0.0 mmHg | Standard Deviation 13.17 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15 hours | 4.3 mmHg | Standard Deviation 16.45 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12 hours | 2.7 mmHg | Standard Deviation 18.01 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6.5 hours | 1.6 mmHg | Standard Deviation 19.24 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 5.5 hours | 2.5 mmHg | Standard Deviation 17.31 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4 hours | 2.3 mmHg | Standard Deviation 14.91 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 15.5 hours | 3.6 mmHg | Standard Deviation 20.19 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22 hours | 3.2 mmHg | Standard Deviation 17.04 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20.5 hours | 1.9 mmHg | Standard Deviation 16.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 4.5 hours | 2.6 mmHg | Standard Deviation 15.2 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21.5 hours | 1.9 mmHg | Standard Deviation 17.95 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16 hours | 3.8 mmHg | Standard Deviation 15.77 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 0.5 hours | -2.2 mmHg | Standard Deviation 15.53 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 8 hours | -0.2 mmHg | Standard Deviation 15.65 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 2.5 hours | 2.4 mmHg | Standard Deviation 16.15 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 19 hours | 1.9 mmHg | Standard Deviation 16.23 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 16.5 hours | 4.5 mmHg | Standard Deviation 17.09 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10 hours | 1.6 mmHg | Standard Deviation 18.16 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1.5 hours | 1.6 mmHg | Standard Deviation 16.49 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9.5 hours | -0.4 mmHg | Standard Deviation 15.64 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 1 hour | 1.7 mmHg | Standard Deviation 16.52 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17 hours | 3.3 mmHg | Standard Deviation 17.81 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 21 hours | 2.0 mmHg | Standard Deviation 17.72 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7.5 hours | 1.2 mmHg | Standard Deviation 17.22 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 12.5 hours | 3.4 mmHg | Standard Deviation 16.25 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 20 hours | 1.1 mmHg | Standard Deviation 14.78 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 17.5 hours | 2.1 mmHg | Standard Deviation 15.5 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11 hours | 0.7 mmHg | Standard Deviation 16.09 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 23.5 hours | 0.9 mmHg | Standard Deviation 15.08 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 10.5 hours | -0.3 mmHg | Standard Deviation 16.86 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 6 hours | 2.5 mmHg | Standard Deviation 17.79 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18 hours | 2.6 mmHg | Standard Deviation 17.1 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 22.5 hours | 4.6 mmHg | Standard Deviation 16.98 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 7 hours | -0.9 mmHg | Standard Deviation 16.11 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 3 hours | 1.9 mmHg | Standard Deviation 19.28 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 9 hours | -1.4 mmHg | Standard Deviation 16.61 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 18.5 hours | 2.3 mmHg | Standard Deviation 15.92 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 11.5 hours | 1.7 mmHg | Standard Deviation 15.13 |
| SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E | Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment. | 13.5 hours | 4.6 mmHg | Standard Deviation 18.61 |
Secondary
Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
Time frame: 90 days
Population: Modified Extension Treatment Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | Plasma T Cmax <=1200 ng/dL after 90days | 114 Participants |
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | Plasma T Cmax <=1440 ng/dL to 2000 ng/dL after 90days | 5 Participants |
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | Plasma T Cmax >2000 ng/dL after 90days | 0 Participants |
Secondary
Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
Time frame: 90 days
Population: Modified Extension Treatment Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | T Cmax <=1500 ng/dL After 90 Days | 81 Participants |
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | T Cmax 1800 to 2500 ng/dL After 90 Days | 4 Participants |
| SOV2012-F1-treated | Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN | T Cmax >2500 ng/dL After 90 Days | 0 Participants |
Other Pre-specified
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects
Time frame: 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any TEAEs | 58 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any Serious TEAEs | 2 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any Treatment-related TEAEs | 13 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any Treatment-related Serious TEAEs | 0 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any Severe TEAEs | 3 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any Treatment-related Severe TEAEs | 0 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any TEAEs leading to Discontinuation from Study Drug | 1 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any TEAEs leading to Death | 0 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any MACE | 0 Participants |
| SOV2012-F1-treated | AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects. | Any TEAEs of Hypertension or Blood Pressure Increased | 6 Participants |
Other Pre-specified
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Measured by in-clinic HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1.
Time frame: Baseline, 90, 119 and 179 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Baseline EXT | 71.9 beats/minute | Standard Deviation 9.48 |
| SOV2012-F1-treated | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 12E - Day 90E | 73.9 beats/minute | Standard Deviation 9.42 |
| SOV2012-F1-treated | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 13E - Day 119E | 72.9 beats/minute | Standard Deviation 9.4 |
| SOV2012-F1-treated | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 15E - Day 179E | 74.3 beats/minute | Standard Deviation 10.26 |
| SERUM | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 15E - Day 179E | 2.6 beats/minute | Standard Deviation 9.37 |
| SERUM | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Baseline EXT | 0 beats/minute | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 13E - Day 119E | 1.1 beats/minute | Standard Deviation 9.13 |
| SERUM | Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period. | Visit 12E - Day 90E | 1.9 beats/minute | Standard Deviation 9.09 |
Other Pre-specified
Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.
Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Baseline | 14.72 g/dL | Standard Deviation 1.094 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Visit 12E - Day 90E | 15.13 g/dL | Standard Deviation 1.488 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Visit 16E - EOT Day 180E | 15.19 g/dL | Standard Deviation 1.49 |
| SERUM | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Baseline | 0 g/dL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Visit 12E - Day 90E | 0.41 g/dL | Standard Deviation 1.082 |
| SERUM | Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period. | Hemoglobin, Visit 16E - EOT Day 180E | 0.48 g/dL | Standard Deviation 1.068 |
Other Pre-specified
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests
Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Baseline | 0.441 mg/dL | Standard Deviation 0.2053 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Visit 12E - Day 90 | 0.361 mg/dL | Standard Deviation 0.1976 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Visit 16E - EOYDay 180 | 0.431 mg/dL | Standard Deviation 0.2383 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Baseline | 0 mg/dL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Visit 12E - Day 90 | -0.077 mg/dL | Standard Deviation 0.1629 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests | Bilirubin, Visit 16E - EOYDay 180 | -0.004 mg/dL | Standard Deviation 0.1863 |
Other Pre-specified
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L)
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Visit 12E - Day 90E | 70.4 U/L | Standard Deviation 50.29 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Visit 16E - Day 180E | 26.9 U/L | Standard Deviation 14.18 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Baseline | 32.0 U/L | Standard Deviation 15.15 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Baseline | 24.1 U/L | Standard Deviation 13.48 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Visit 16E - EOT Day 180E | 65.0 U/L | Standard Deviation 18.43 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Visit 12E - Day 90E | 22.5 U/L | Standard Deviation 9.36 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Visit 12E - Day 90E | 26.5 U/L | Standard Deviation 12.1 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Visit 16E - Day 180E | 21.6 U/L | Standard Deviation 8.73 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Baseline | 72.5 U/L | Standard Deviation 22.9 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Visit 16E - Day 180E | -1.9 U/L | Standard Deviation 13.28 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Baseline | 0 U/L | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Visit 12E - Day 90E | -2.2 U/L | Standard Deviation 33.68 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alkaline Phosphatase, Visit 16E - EOT Day 180E | -5.7 U/L | Standard Deviation 10.6 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Baseline | 0 U/L | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Visit 12E - Day 90E | -5.1 U/L | Standard Deviation 13.37 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Alanine Aminotransferase (ALT), Visit 16E - Day 180E | -4.2 U/L | Standard Deviation 14.46 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Baseline | 0 U/L | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase | Aspartate Aminotransferase (AST), Visit 12E - Day 90E | -1.4 U/L | Standard Deviation 14.26 |
Other Pre-specified
Observed and Change From Baseline in Hormone Levels.
Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Baseline | 5.91 mIU/mL | Standard Deviation 4.119 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Visit 12E - Day 90E | 2.13 mIU/mL | Standard Deviation 2.534 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Visit 16E - EOT Day 180E | 2.39 mIU/mL | Standard Deviation 2.821 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Baseline | 5.83 mIU/mL | Standard Deviation 4.89 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Visit 12E - Day 90E | 2.47 mIU/mL | Standard Deviation 3.037 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Visit 16E - EOT Day 180E | 2.52 mIU/mL | Standard Deviation 3.073 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Visit 12E - Day 90E | -3.28 mIU/mL | Standard Deviation 4.506 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Baseline | 0 mIU/mL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Baseline | 0 mIU/mL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Visit 12E - Day 90E | -3.71 mIU/mL | Standard Deviation 4.41 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Follicle Stimulating Hormone, Visit 16E - EOT Day 180E | -3.19 mIU/mL | Standard Deviation 4.457 |
| SERUM | Observed and Change From Baseline in Hormone Levels. | Luteinizing Hormone, Visit 16E - EOT Day 180E | -3.37 mIU/mL | Standard Deviation 4.342 |
Other Pre-specified
Observed and Change From Baseline in Hormone Levels for SHBG.
Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Baseline | 28.81 nmol/L | Standard Deviation 14.193 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Visit 12E - Day 90E | 20.30 nmol/L | Standard Deviation 12.254 |
| SOV2012-F1-treated | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Visit 16E - EOT Day 180E | 18.97 nmol/L | Standard Deviation 11.385 |
| SERUM | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Baseline | 0 nmol/L | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Visit 12E - Day 90E | -8.53 nmol/L | Standard Deviation 7.901 |
| SERUM | Observed and Change From Baseline in Hormone Levels for SHBG. | Sex Hormone Binding Globulin, Visit 16E - EOT Day 180E | -10.45 nmol/L | Standard Deviation 8.63 |
Other Pre-specified
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Baseline | 120.8 mg/dL | Standard Deviation 35.85 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Visit 16E - EOT Day 180E | 176.2 mg/dL | Standard Deviation 41.62 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Visit 12E - Day 90E | 113.4 mg/dL | Standard Deviation 37.52 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Visit 12E - Day 90E | 37.2 mg/dL | Standard Deviation 9.74 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Visit 16E - EOT Day 180E | 117.7 mg/dL | Standard Deviation 38.2 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Baseline | 45.3 mg/dL | Standard Deviation 11.94 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Baseline | 179.3 mg/dL | Standard Deviation 123.6 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Visit 12E - Day 90E | 171.7 mg/dL | Standard Deviation 40.52 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Visit 12E - Day 90E | 158.9 mg/dL | Standard Deviation 83.79 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Visit 16E - EOT Day 180E | 38.2 mg/dL | Standard Deviation 10.37 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Visit 16E - EOT Day 180E | 160.1 mg/dL | Standard Deviation 102.9 |
| SOV2012-F1-treated | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Baseline | 186.4 mg/dL | Standard Deviation 38.38 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Visit 16E - EOT Day 180E | -18.6 mg/dL | Standard Deviation 106.48 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Baseline | 0 mg/dL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Visit 12E - Day 90E | -14.5 mg/dL | Standard Deviation 31.69 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Cholesterol, Visit 16E - EOT Day 180E | -11.1 mg/dL | Standard Deviation 30.5 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Visit 12E - Day 90E | -7.8 mg/dL | Standard Deviation 7.75 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Visit 16E - EOT Day 180E | -6.9 mg/dL | Standard Deviation 8.7 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Baseline | 0 mg/dL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Visit 12E - Day 90E | -7.8 mg/dL | Standard Deviation 27.57 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | LDL Cholesterol, Visit 16E - EOT Day 180E | -4.0 mg/dL | Standard Deviation 29.14 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Baseline | 0 mg/dL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | Triglycerides, Visit 12E - Day 90E | -16.7 mg/dL | Standard Deviation 101.61 |
| SERUM | Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period. | HDL Cholesterol, Baseline | 0 mg/dL | Standard Deviation 0 |
Other Pre-specified
Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.
Serum prostate-specific antigen (PSA) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of ng/mL.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Visit 12E - Day 90E | 1.10 ng/mL | Standard Deviation 0.719 |
| SOV2012-F1-treated | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Visit 16E - EOT Day 180E | 1.09 ng/mL | Standard Deviation 0.743 |
| SOV2012-F1-treated | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Baseline | 0.98 ng/mL | Standard Deviation 0.651 |
| SERUM | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Baseline | 0 ng/mL | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Visit 12E - Day 90E | 0.15 ng/mL | Standard Deviation 0.309 |
| SERUM | Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period. | Prostate Specific Antigen, Visit 16E - EOT Day 180E | 0.15 ng/mL | Standard Deviation 0.443 |
Other Pre-specified
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1.
Time frame: Baseline, 90, 119 and 179 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Baseline EXT | 126.10 mmHg | Standard Deviation 9.8 |
| SOV2012-F1-treated | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 12E - Day 90E | 127.89 mmHg | Standard Deviation 9.961 |
| SOV2012-F1-treated | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 15E - Day 179E | 128.09 mmHg | Standard Deviation 10.012 |
| SOV2012-F1-treated | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 13E - Day 119E | 128.51 mmHg | Standard Deviation 10.912 |
| SERUM | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 13E - Day 119E | 2.70 mmHg | Standard Deviation 10.695 |
| SERUM | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Baseline EXT | 0 mmHg | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 15E - Day 179E | 2.39 mmHg | Standard Deviation 10.522 |
| SERUM | Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement. | Visit 12E - Day 90E | 2.06 mmHg | Standard Deviation 10.303 |
Other Pre-specified
Observed and Change From Baseline in Thyrotropin
Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L.
Time frame: 90 and 180 days
Population: Extension Treated Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOV2012-F1-treated | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Baseline | 3.014 mU/L | Standard Deviation 6.8492 |
| SOV2012-F1-treated | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Visit 12E - Day 90E | 2.985 mU/L | Standard Deviation 3.9809 |
| SOV2012-F1-treated | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Visit 16E - EOT Day 180E | 2.263 mU/L | Standard Deviation 1.256 |
| SERUM | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Baseline | 0 mU/L | Standard Deviation 0 |
| SERUM | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Visit 12E - Day 90E | -0.101 mU/L | Standard Deviation 5.9459 |
| SERUM | Observed and Change From Baseline in Thyrotropin | Thyrotropin, Visit 16E - EOT Day 180E | 0.003 mU/L | Standard Deviation 1.0863 |