Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).

All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour SBP.

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).

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.

All randomized participants who received at least one dose of study drug and had a baseline measurement for daytime and nighttime SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour 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.

All randomized participants who received at least one dose of study drug and had a baseline measurement for 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. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough SBP.

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.

All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime DBP.

Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

All randomized participants who received at least one dose of study drug and had a baseline measurement for 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. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough DBP.

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.

All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime heart rate.

Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.

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.

All randomized participants who received at least one dose of study drug and had a baseline measurement for 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. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough heart rate.

Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours).

All randomized participants who received at least one dose of study drug and had a baseline measurement for 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). In the case of missing data, LOCF.

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for 24-hour urinary glucose excretion.

For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).

All randomized participants.

For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 4 for FPG (observed cases).

For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).

Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 2 for FPG (observed cases).

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.

Analysis population consisted of all randomized participants who received at least one dose of study drug.

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.

Analysis population consisted of all randomized participants who received at least one dose of study drug.