| Outcome Measures: |
Primary: Baseline 24-hour Average Systolic Blood Pressure (SBP), Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM)., 24 hours|Change From Baseline on 24-hour Average SBP at Week 4, Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF)., Baseline and Week 4 | Secondary: Baseline Average Daytime and Nighttime SBP, Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., Daytime: 16 hours; Nighttime: 8 hours|Change From Baseline on Daytime Average SBP at Week 4, Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time., Baseline and Week 4|Change From Baseline on Nighttime Average SBP at Week 4, Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., Baseline and Week 4|Baseline Seated, Triplicate Trough SBP, Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures., Baseline|Change From Baseline in Seated, Triplicate Trough SBP at Week 4, Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments., Baseline and Week 4|Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP), Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., up to 24 hours|Change From Baseline on 24-hour Average DBP at Week 4, Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF., Baseline and Week 4|Change From Baseline on Daytime Average DBP at Week 4, Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time., Baseline and Week 4|Change From Baseline on Nighttime Average DBP at Week 4, Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., Baseline and Week 4|Baseline Seated, Triplicate Trough DBP, Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures., Baseline|Change From Baseline in Seated, Triplicate Trough DBP at Week 4, Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments., Baseline and Week 4|Baseline 24-hour, Daytime and Nightime Average Heart Rate, Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., up to 24 hours|Change From Baseline on 24-hour Average Heart Rate at Week 4, Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM., Baseline and Week 4|Change From Baseline on Daytime Average Heart Rate at Week 4, Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time., Baseline and Week 4|Change From Baseline on Nighttime Average Heart Rate at Week 4, Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time., Baseline and Week 4|Baseline Seated, Triplicate Trough Heart Rate, Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures., Baseline|Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4, Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments., Baseline and Week 4|Baseline 24-hour Average Urinary Glucose Excretion, Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours)., 24 hours|Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4, Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours). In the case of missing data, LOCF., Baseline and Week 4|Baseline Fasting Plasma Glucose (FPG), For FPG, blood was drawn after an overnight fast of at least 8 hours (except water)., Baseline|Change From Baseline in FPG at Week 4, For FPG, blood was drawn after an overnight fast of at least 8 hours (except water)., Baseline and Week 4|Change From Baseline in FPG at Week 2, For FPG, blood was drawn after an overnight fast of at least 8 hours (except water)., Baseline and Week 2|Number of Participants Who Experienced an Adverse Event (AE), An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug., Up to 63 days (including run-in, treatment period, and follow-up)|Number of Participants Who Discontinued Study Drug Due to an AE, An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE., Up to 28 days (treatment period)
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