Clinical Study to Assess the Safety and Pharmacokinetics... | NCT00937326

Name	Class
GlaxoSmithKline	INDUSTRY

Clinical Study to Assess the Safety and Pharmacokinetics... | NCT00937326 | Trialant

Description Module

Detailed Description

Study Objectives

Primary:

To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days.
To characterize the pharmacokinetic profile of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) after a single dose and multiple administrations in type 2 diabetic subjects.

Secondary:

1. To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.

Study Design:

Prospective, multi-center, clinical study of SRT2104 administered orally once daily for 28 consecutive days; randomized, placebo-controlled, double-blind, multiple-dose, inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in type 2 diabetic male and female subjects on an existing, stable, background metformin therapy. Approximately 225 subjects aged 30-70, who fulfill the inclusion/exclusion criteria, will be enrolled in this study to ensure completion of forty (40) evaluable subjects within each of five dosing groups. Subjects will be evenly randomized to receive SRT2104 at one of five doses, placebo (A), 0.25 g/day (B), 0.5 g/day (C), 1.0 g/day (D), or 2.0 g/day (E), once a day for 28 consecutive days, approximately 15 minutes following consumption of a standardized meal. Subjects will remain on a fixed dose of test material for all dosing days in the study.

Subjects will sign the informed consent form at the Screening Visit, and will undergo screening assessments over a 2-day period to verify eligibility for the study. If eligible and willing to participate, subjects will return to the clinic within 21 days of the Screening Visit to participate in the dosing phase of the study. Subjects will be randomized to receive SRT2104 or placebo, and will be required to stay overnight at the study center on Day -1 and Day 27 to gather required PK samples and to assess safety on Day 1 and Day 28 respectively. In addition, subjects will be asked to return to the study center on Days 2 and 29; for three interim weekly safety assessments (on Days 8, 15, 22); and for an End of Study safety assessment 7 days after they complete the 28-day dosing period. A follow-up safety call will be made to each subject 30 days following their final dose of SRT2104 or placebo.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	The Placebo treatment group will be administered eight placebo capsules per day. Placebo will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every morning, approximately 15 minutes following consumption of a standardized meal and should be administered with approximately 1 to 2 glasses of water.	Drug: Placebo
Arm1 - 0.25g	Active Comparator	The 0.25g SRT2104 treatment group will be administered one SRT2104 capsules with 7 placebo capsules, for a total of 8 capsules per day. 0.25g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every morning, 15 minutes following consumption of a standardized meal and should be administered with approximately 1 to 2 glasses of water.	Drug: SRT2104 Drug: Placebo
Arm2 - 0.5g	Active Comparator	The 0.5g SRT2104 treatment group will be administered two SRT2104 capsules with 6 placebo capsules, for a total of 8 capsules per day. 0.5g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every morning, 15 minutes following consumption of a standardized meal and should be administered with approximately 1 to 2 glasses of water.	Drug: SRT2104 Drug: Placebo
Arm3 - 1g	Active Comparator	The 1g SRT2104 treatment group will be administered four SRT2104 capsules with four placebo capsules, for a total of 8 capsules per day. 1g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every morning, 15 minutes following consumption of a standardized meal and should be administered with approximately 1 to 2 glasses of water.

Name	Type	Description	Arm Group Labels	Other Names
SRT2104	Drug	SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.	Arm1 - 0.25g Arm2 - 0.5g Arm3 - 1g Arm4 - 2g

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death	An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment.	Up to Follow-up (58 days)
Number of Participants With AE by Intensity of Mild, Moderate and Severe	Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities.	Up to Follow-up (58 days)
Mean Change From Baseline in Weight Over Time	Participant's body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.	Baseline (Day 1) and up to Day 35
Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time

Secondary Outcomes

Measure	Description	Time Frame
Mean Fasting Plasma Glucose (FPG) Levels Over Time	The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.	Up to Day 35
Change From Baseline in FPG Levels Over Time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects of any race and gender within the age range of 30 to 70 years.
All female subjects must be of non-child-bearing potential. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 138 mIU/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the subject's medical record. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor
All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
Willingness to provide written informed consent to participate in the study
HbA1c ≥ 7.5 and ≤ 10.5
Fasting glucose ≥ 160 and ≤ 240 mg/dL
Body Mass Index (BMI) ≥ 25.0 kg/m^2 and ≤ 40.0 kg/m^2
On stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to Screening
No prior history of HIV 1 or 2
Absence of disease markers for hepatitis B & C virus
Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function
Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant
Have a normal chest X-ray (P. A. View) or one with abnormality considered to be clinically insignificant
Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol

Exclusion Criteria:

Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
Renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males, and greater than two times the upper limit of normal for liver enzymes, respectively.
History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
History, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC)
History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
Participation in any clinical trial within the past three months
History of difficulty in donating blood or accessibility of veins in left or right arm
Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
Use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to Screening, provided the medication is not contraindicated by the metformin label
Use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Byala		7100	Bulgaria
GSK Investigational Site

References Module

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
113160	Statistical Analysis Plan	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes (min) following the start of meal consumption with 1 to 2 glasses of water.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0013 subjects FG0021 subjects FG0031 subjects FG0042 subjects
Death		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0003 subjects FG0014 subjects FG0021 subjects FG0034 subjects FG004
Chest X-ray showed a suspicious shadow		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
BG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
BG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
BG003	SRT2104 1.0 g/Day	Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
BG004	SRT2104 2.0 g/Day	Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00055.8± 8.40 BG00158.2± 8.04 BG00257.7± 9.00 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00028 BG00122 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment.

Safety Analysis Set (SAF) Population was defined as all participants who received at least one dose of any test material during the study.

Posted

Count of Participants

Participants

Up to Follow-up (58 days)

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG003	SRT2104 1.0 g/Day	Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG004	SRT2104 2.0 g/Day	Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Units	Counts
Participants	OG00043 OG00143 OG00244 OG003

Title

Denominators

Categories

Any AE

Title	Measurements
	OG00011 OG00115 OG00219 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Placebo versus SRT2104 0.25 g/day in number of participants with any AE.	Fisher Exact		0.4816	No adjustments for covariates were made.													Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day in number of participants with any AE.

Primary

Number of Participants With AE by Intensity of Mild, Moderate and Severe

Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities.

Safety Analysis Set Population.

Posted

Count of Participants

Participants

Up to Follow-up (58 days)

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Mean Change From Baseline in Weight Over Time

Participant's body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Kilogram (kg)

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time

Vital sign assessment of SBP and DBP was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimeter of mercury (mmHg)

Baseline (Day 1, pre-dose) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time

Vital sign assessment of HR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute (bpm)

Baseline (Day 1, pre-dose) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day

Primary

Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time

Vital sign assessment of RR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Breaths per minute

Baseline (Day 1, pre-dose) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001

Primary

Change From Baseline in Vital Sign Parameter of Temperature Over Time

Vital sign assessment of temperature was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Degree celcius

Baseline (Day 1, pre-dose) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day

Primary

Change From Baseline in Electrocardiogram (ECG) Values Over Time

12-lead ECG was obtained in the rested state. Participants lied in supine position with ECG leads on for at least 5 minutes prior to ECG recording. The ECG was performed at Day 1 (pre-dose and post-dose), Day 8, Day 15, Day 22, Day 28 (pre-dose and pre-dose) and Day 35, and included the assessment of PR interval, QRS interval, QT interval and QTc interval. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1 [post-dose], Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millisecond

Baseline (Day 1, pre-dose) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time

Assessment for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and white blood cell (WBC) count were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Giga cells per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time

Assessment for RBC count was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Trillion cells per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Hematology Parameter of Hematocrit Over Time

Assessment for hematocrit was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Hematology Parameter of Hemoglobin Over Time

Assessment for hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Gram per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time

Assessment for mean corpuscular hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Picogram per cell

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002

Primary

Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time

Assessment for mean corpuscular hemoglobin concentration was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Gram hemoglobin per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002

Primary

Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time

Assessment for mean corpuscular volume was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Femtoliter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time

Assessment for aPTT and PT were performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Seconds

Baseline (Day 1), Day 28 and Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time

Assessment for international normalized ratio was performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1), Day 28 and Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time

Assessment for ALT, AST, ALP, creatinine phosphokinase and LDH were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

International units per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time

Assessment for bicarbonate, BUN, calcium, chloride, magnesium, phosphate, potassium and sodium were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromole (mmol) per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time

Assessment for direct bilirubin, indirect bilirubin, serum creatinine, total bilirubin and uric acid were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromole per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Chemistry Parameter of Lipid Profile Over Time

Assessment for lipid profile was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. The parameters included high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and triglycerides. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time

Assessment for albumin and total protein were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Gram per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Primary

Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time

Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Change From Baseline in Urinalysis Parameter of pH Over Time

Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessment was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Points on scale

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28

The pre-dose blood samples were collected within one hour prior to study medication administration. The post-dose blood samples were collected within 2 minutes of the scheduled time. AUC values reported in the analysis of AUC 0-infinity of Day 28 versus Day 1 included AUC 0-infinity on Day 1 and AUC 0-τ on Day 28. Participants fasted for at least 10 hour overnight on Day 1, 2 and 29. The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC0-infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log10 transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.

Pharmacokinetic (PK) Population defined as all participants who received SRT2104, had sufficient blood samples taken to obtain a plasma concentration time profile and who did not violate the protocol in such a way that it could influence the statistical analysis. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Nanogram (ng)*hour/milliliter (mL)

Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28)

ID	Title	Description

Primary

Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28

Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. On Day 1, Day 2 and Day 29, participants fasted for at least 10 hour overnight. The post-dose sample was collected within 2 minutes of the scheduled time. The first occurrence of the Cmax was determined directly from the raw concentration-time data.

PK Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

ng/mL

ID	Title	Description
OG000	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.5 g/Day

Primary

Time to Cmax (Tmax) at Day 1 and Day 28

Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. The time at which Cmax was observed was determined directly from the raw concentration-time data.

PK Population. Only those participants available at the specified time points were analyzed.

Posted

Median

Full Range

hour

ID	Title	Description
OG000	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Primary

Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28

Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. The t1/2 was obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the concentration-time data.

PK Population. Only those participants available at the specified time points were analyzed.

Posted

Median

Full Range

hour

ID	Title	Description
OG000	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001

Primary

Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28

Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.

PK Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Liter/hour

ID	Title	Description
OG000	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.5 g/Day

Primary

Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28

Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.

PK Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mL/kg

ID	Title	Description
OG000	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.5 g/Day

Secondary

Mean Fasting Plasma Glucose (FPG) Levels Over Time

The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in FPG Levels Over Time

The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002

Secondary

Mean Fasting Plasma Insulin (FPI) Levels Over Time

The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in FPI Over Time

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Baseline (Day 1) and up to Day 35

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002

Secondary

Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28

The assessment of PPG and PPI was performed on Day 28 at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast).

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in PPG and PPI Levels at Day 28

The assessment of PPG and PPI was performed at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. Baseline for PPG was defined as the assessment value of FPG done on Day 1 and Baseline for PPI was defined as the assessment value of FPI done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (30 min, 60 min and 2 h at Day 28) values.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol per liter

Baseline (Day 1) and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28

The sample for HbA1c assessment was collected on Day 28. HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in HbA1c Levels at Day 28

HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected on Day 1 and Day 28. Baseline value was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline (Day 1) and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28

The assessment of PPG and PPI was performed at 30 minutes, 60 minnutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. AUC with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times) for PPG and PPI.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol*hour per liter

Day 1 (30 minutes, 60 minutes and 2 hour) and Day 28 (30 minutes, 60 minutes and 2 hour)

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Mean Fructosamine Levels at Day 1 and Day 28

ITT Population.

Posted

Mean

Standard Deviation

mmol/L

Day 1 and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in Fructosamine Levels at Day 28

Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.

ITT Population.

Posted

Mean

Standard Deviation

mmol per liter

Baseline (Day 1) and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Secondary

Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28

HOMA-IR was derived from FPG and FPI as: FPI (micro units [mU]/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mU*mmol per liter^2

Day 1 and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Secondary

Change From Baseline in HOMA-IR at Day 28

HOMA-IR was derived from FPG and FPI as: FPI (mU/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mU*mmol per liter^2

Baseline (Day 1) and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Secondary

Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of beta cell function

Day 1 and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG002	SRT2104 0.5 g/Day

Secondary

Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28

HOMA-percentage cell beta function was derived from FPG and FPI as: 20*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as assessment done on Day 1. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.

ITT Population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of beta cell function

Baseline (Day 1) and Day 28

ID	Title	Description
OG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
OG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.	0	43	0	43	7	43
EG001	SRT2104 0.25 g/Day	Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.	0	43	1	43	4	43
EG002	SRT2104 0.5 g/Day	Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.	1	44	1	44	12	44
EG003	SRT2104 1.0 g/Day	Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.	0	42	0	42	5	42
EG004	SRT2104 2.0 g/Day	Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.	0	43	0	43	8	43

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected43 at risk EG0021 affected44 at risk EG0030 affected42 at risk EG0040 affected43 at risk
Wound infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected43 at risk EG0021 affected44 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected43 at risk EG0020 affected44 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected43 at risk EG0011 affected43 at risk EG0024 affected44 at risk EG0031 affected42 at risk EG0042 affected43 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected43 at risk EG0013 affected43 at risk EG0024 affected44 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected43 at risk EG0024 affected44 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected43 at risk EG0011 affected43 at risk EG0023 affected44 at risk EG003

Title

Denominators

Categories

Day 28

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340
- ParticipantsOG00439

Title	Measurements
	OG000-0.17± 1.25 OG001-0.81± 2.21 OG002-1.25± 2.06 OG003

Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339

Title

Denominators

Categories

SBP, Day 1, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342
- ParticipantsOG00442

Title	Measurements
	OG000-1.49± 9.45 OG0011.30± 8.36 OG0020.36± 5.27 OG003

SBP, Day 1, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 1 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 2 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 3 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 4 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 8 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 12 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 1, 24 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

SBP, Day 2, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

SBP, Day 2, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00342

SBP, Day 2, 30 minutes

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

SBP, Day 2, 1 hour

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

SBP, Day 8, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

SBP, Day 8, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

SBP, Day 8, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

SBP, Day 8, 1 hour

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

SBP, Day 15, pre-dose

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00243
- ParticipantsOG00341

SBP, Day 15, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

SBP, Day 15, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00239
- ParticipantsOG00341

SBP, Day 15, 1 hour

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00341

SBP, Day 22, pre-dose

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

SBP, Day 22, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 22, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

SBP, Day 22, 1 hour

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

SBP, Day 27

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, pre-dose

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 1 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 3 hour

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 4 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 8 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 12 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 28, 24 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

SBP, Day 35

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00243
- ParticipantsOG00341

DBP, Day 1, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 1 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 2 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 3 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 4 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 8 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 12 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 1, 24 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

DBP, Day 2, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

DBP, Day 2, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00342

DBP, Day 2, 30 minutes

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

DBP, Day 2, 1 hour

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

DBP, Day 8, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

DBP, Day 8, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

DBP, Day 8, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

DBP, Day 8, 1 hour

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

DBP, Day 15, pre-dose

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00243
- ParticipantsOG00341

DBP, Day 15, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

DBP, Day 15, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00239
- ParticipantsOG00341

DBP, Day 15, 1 hour

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00341

DBP, Day 22, pre-dose

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

DBP, Day 22, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 22, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

DBP, Day 22, 1 hour

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

DBP, Day 27

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, pre-dose

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 1 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 3 hour

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 4 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 8 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 12 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 28, 24 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

DBP, Day 35

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00243
- ParticipantsOG00341

Title

Denominators

Categories

Day 1, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342
- ParticipantsOG00442

Title	Measurements
	OG000-0.02± 5.82 OG0011.02± 5.24 OG0020.23± 5.08 OG003

Day 1, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 1 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 2 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 3 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 4 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 8 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 12 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 24 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

Day 2, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 2, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00342

Day 2, 30 minutes

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 2, 1 hour

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 8, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

Day 8, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

Day 8, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 8, 1 hour

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 15, pre-dose

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00243
- ParticipantsOG00341

Day 15, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Day 15, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00239
- ParticipantsOG00341

Day 15, 1 hour

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00341

Day 22, pre-dose

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

Day 22, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

Day 22, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 22, 1 hour

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 27

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, pre-dose

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 1 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 3 hour

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 4 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 8 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 12 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 24 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

Day 35

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00243
- ParticipantsOG00341

Title

Denominators

Categories

Day 1, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342
- ParticipantsOG00442

Title	Measurements
	OG0000.14± 0.89 OG001-0.07± 1.12 OG002-0.16± 1.15 OG003

Day 1, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 1 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 2 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 3 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 4 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 8 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 12 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 24 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

Day 2, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 2, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00342

Day 2, 30 minutes

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 2, 1 hour

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 8, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

Day 8, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

Day 8, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 8, 1 hour

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 15, pre-dose

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00243
- ParticipantsOG00341

Day 15, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Day 15, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00239
- ParticipantsOG00341

Day 15, 1 hour

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00341

Day 22, pre-dose

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

Day 22, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

Day 22, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 22, 1 hour

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 27

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, pre-dose

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 1 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 3 hour

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 4 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 8 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 12 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 24 hour

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

Day 35

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00243
- ParticipantsOG00341

Title

Denominators

Categories

Day 1, 15 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342
- ParticipantsOG00442

Title	Measurements
	OG0000.03± 0.12 OG001-0.00± 0.14 OG0020.01± 0.11 OG003

Day 1, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 1 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 2 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 3 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 4 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 8 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 12 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 1, 24 hour

- ParticipantsOG00043
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00342

Day 2, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00342

Day 2, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00342

Day 2, 30 minutes

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 2, 1 hour

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00341

Day 8, pre-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

Day 8, 5 minutes

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

Day 8, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 8, 1 hour

- ParticipantsOG00038
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00340

Day 15, pre-dose

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00243
- ParticipantsOG00341

Day 15, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Day 15, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00239
- ParticipantsOG00341

Day 15, 1 hour

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00341

Day 22, pre-dose

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

Day 22, 5 minutes

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

Day 22, 30 minutes

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 22, 1 hour

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00340

Day 27

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, pre-dose

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00340

Day 28, 15 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 30 minutes

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 1 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 3 hour

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 4 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 8 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 12 hour

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00340

Day 28, 24 hour

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00340

Day 35

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00243
- ParticipantsOG00341

Title

Denominators

Categories

PR interval, Day 1, post-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341
- ParticipantsOG00442

Title	Measurements
	OG0000.12± 9.92 OG0011.47± 13.07 OG0020.58± 12.43 OG003

PR interval, Day 8

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

PR interval, Day 15

- ParticipantsOG00042
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00341

PR interval, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

PR interval, Day 28, pre-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

PR interval, Day 28, post-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

PR interval, Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00341

QRS interval, Day 1, post-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

QRS interval, Day 8

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

QRS interval, Day 15

- ParticipantsOG00042
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00341

QRS interval, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

QRS interval, Day 28, pre-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QRS interval, Day 28, post-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QRS interval, Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00341

QT interval, Day 1, post-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

QT interval, Day 8

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

QT interval, Day 15

- ParticipantsOG00042
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00341

QT interval, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

QT interval, Day 28, pre-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QT interval, Day 28, post-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QT interval, Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00341

QTc interval, Day 1, post-dose

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00341

QTc interval, Day 8

- ParticipantsOG00042
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00341

QTc interval, Day 15

- ParticipantsOG00042
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00341

QTc interval, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

QTc interval, Day 28, pre-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QTc interval, Day 28, post-dose

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

QTc interval, Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00341

Title

Denominators

Categories

Baseophil count, Day 8

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00236
- ParticipantsOG00331
- ParticipantsOG00437

Title	Measurements
	OG0000.01± 0.02 OG0010.00± 0.02 OG0020.00± 0.01 OG003

Baseophil count, Day 15

- ParticipantsOG00038
- ParticipantsOG00132
- ParticipantsOG00235
- ParticipantsOG00333

Baseophil count, Day 22

- ParticipantsOG00034
- ParticipantsOG00133
- ParticipantsOG00237
- ParticipantsOG00335

Baseophil count, Day 28

- ParticipantsOG00037
- ParticipantsOG00129
- ParticipantsOG00235
- ParticipantsOG00332

Baseophil count Day 35

- ParticipantsOG00036
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00333

Eosinophil count, Day 8

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00236
- ParticipantsOG00331

Eosinophil count, Day 15

- ParticipantsOG00038
- ParticipantsOG00132
- ParticipantsOG00235
- ParticipantsOG00333

Eosinophil count, Day 22

- ParticipantsOG00034
- ParticipantsOG00133
- ParticipantsOG00237
- ParticipantsOG00335

Eosinophil count, Day 28

- ParticipantsOG00037
- ParticipantsOG00129
- ParticipantsOG00235
- ParticipantsOG00332

Eosinophil count, Day 35

- ParticipantsOG00036
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00333

Lymphocyte count, Day 8

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00236
- ParticipantsOG00331

Lymphocyte count, Day 15

- ParticipantsOG00038
- ParticipantsOG00132
- ParticipantsOG00235
- ParticipantsOG00333

Lymphocyte count, Day 22

- ParticipantsOG00034
- ParticipantsOG00133
- ParticipantsOG00237
- ParticipantsOG00335

Lymphocyte count, Day 28

- ParticipantsOG00037
- ParticipantsOG00129
- ParticipantsOG00235
- ParticipantsOG00332

Lymphocyte count, Day 35

- ParticipantsOG00036
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00333

Monocyte count, Day 8

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00236
- ParticipantsOG00331

Monocyte count, Day 15

- ParticipantsOG00038
- ParticipantsOG00132
- ParticipantsOG00235
- ParticipantsOG00333

Monocyte count, Day 22

- ParticipantsOG00034
- ParticipantsOG00133
- ParticipantsOG00237
- ParticipantsOG00335

Monocyte count, Day 28

- ParticipantsOG00037
- ParticipantsOG00129
- ParticipantsOG00235
- ParticipantsOG00332

Monocyte count, Day 35

- ParticipantsOG00036
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00333

Neutrophil count, Day 8

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00236
- ParticipantsOG00331

Neutrophil count, Day 15

- ParticipantsOG00038
- ParticipantsOG00132
- ParticipantsOG00235
- ParticipantsOG00333

Neutrophil count, Day 22

- ParticipantsOG00034
- ParticipantsOG00133
- ParticipantsOG00237
- ParticipantsOG00335

Neutrophil count, Day 28

- ParticipantsOG00037
- ParticipantsOG00129
- ParticipantsOG00235
- ParticipantsOG00332

Neutrophil count, Day 35

- ParticipantsOG00036
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00333

Platelet count, Day 8

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00238
- ParticipantsOG00337

Platelet count, Day 15

- ParticipantsOG00036
- ParticipantsOG00133
- ParticipantsOG00239
- ParticipantsOG00335

Platelet count, Day 22

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00238
- ParticipantsOG00337

Platelet count, Day 28

- ParticipantsOG00039
- ParticipantsOG00132
- ParticipantsOG00238
- ParticipantsOG00337

Platelet count, Day 35

- ParticipantsOG00035
- ParticipantsOG00137
- ParticipantsOG00240
- ParticipantsOG00334

WBC count, Day 8

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00238
- ParticipantsOG00338

WBC count, Day 15

- ParticipantsOG00039
- ParticipantsOG00135
- ParticipantsOG00239
- ParticipantsOG00336

WBC count, Day 22

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00338

WBC count, Day 28

- ParticipantsOG00040
- ParticipantsOG00134
- ParticipantsOG00239
- ParticipantsOG00338

WBC count, Day 35

- ParticipantsOG00036
- ParticipantsOG00139
- ParticipantsOG00240
- ParticipantsOG00336

Title

Denominators

Categories

Day 8

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00338
- ParticipantsOG00441

Title	Measurements
	OG000-0.02± 0.19 OG0010.03± 0.31 OG002-0.02± 0.24 OG003

Day 15

- ParticipantsOG00039
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00336

Day 22

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Day 28

- ParticipantsOG00040
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Day 35

- ParticipantsOG00036
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00336

Title

Denominators

Categories

Day 8

- ParticipantsOG00035
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00336
- ParticipantsOG00430

Title	Measurements
	OG000-0.00± 0.02 OG0010.00± 0.03 OG002-0.00± 0.03 OG003

Day 15

- ParticipantsOG00034
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00332

Day 22

- ParticipantsOG00035
- ParticipantsOG00132
- ParticipantsOG00240
- ParticipantsOG00335

Day 28

- ParticipantsOG00032
- ParticipantsOG00127
- ParticipantsOG00234
- ParticipantsOG00334

Day 35

- ParticipantsOG00034
- ParticipantsOG00131
- ParticipantsOG00237
- ParticipantsOG00331

Title

Denominators

Categories

Day 8

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00338
- ParticipantsOG00441

Title	Measurements
	OG000-0.75± 5.17 OG0011.49± 9.28 OG002-0.03± 7.36 OG003

Day 15

- ParticipantsOG00039
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00336

Day 22

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Day 28

- ParticipantsOG00040
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Day 35

- ParticipantsOG00036
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00336

Title

Denominators

Categories

Day 8

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00338
- ParticipantsOG00441

Title	Measurements
	OG0000.00± 0.72 OG0010.15± 0.79 OG0020.23± 0.62 OG003

Day 15

- ParticipantsOG00039
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00336

Day 22

- ParticipantsOG00038
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Day 28

- ParticipantsOG00040
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Day 35

- ParticipantsOG00036
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00336

Title

Denominators

Categories

Day 8

- ParticipantsOG00035
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00336
- ParticipantsOG00430

Title	Measurements
	OG000-1.43± 8.10 OG0010.00± 7.56 OG0020.77± 8.39 OG003

Day 15

- ParticipantsOG00034
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00332

Day 22

- ParticipantsOG00035
- ParticipantsOG00132
- ParticipantsOG00240
- ParticipantsOG00335

Day 28

- ParticipantsOG00032
- ParticipantsOG00127
- ParticipantsOG00234
- ParticipantsOG00334

Day 35

- ParticipantsOG00034
- ParticipantsOG00131
- ParticipantsOG00237
- ParticipantsOG00331

Title

Denominators

Categories

Day 8

- ParticipantsOG00035
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00336
- ParticipantsOG00430

Title	Measurements
	OG0000.20± 1.21 OG0010.28± 1.77 OG0020.18± 1.68 OG003

Day 15

- ParticipantsOG00034
- ParticipantsOG00132
- ParticipantsOG00237
- ParticipantsOG00332

Day 22

- ParticipantsOG00035
- ParticipantsOG00132
- ParticipantsOG00240
- ParticipantsOG00335

Day 28

- ParticipantsOG00032
- ParticipantsOG00127
- ParticipantsOG00234
- ParticipantsOG00334

Day 35

- ParticipantsOG00034
- ParticipantsOG00131
- ParticipantsOG00237
- ParticipantsOG00331

Title

Denominators

Categories

aPTT, Day 28

- ParticipantsOG00033
- ParticipantsOG00135
- ParticipantsOG00231
- ParticipantsOG00333
- ParticipantsOG00434

Title	Measurements
	OG0000.53± 6.78 OG0011.51± 9.88 OG002-1.58± 6.98 OG003

aPTT, Day 35

- ParticipantsOG00034
- ParticipantsOG00138
- ParticipantsOG00233
- ParticipantsOG00337

PT, Day 28

- ParticipantsOG00034
- ParticipantsOG00134
- ParticipantsOG00231
- ParticipantsOG00333

PT, Day 35

- ParticipantsOG00035
- ParticipantsOG00137
- ParticipantsOG00233
- ParticipantsOG00337

Title

Denominators

Categories

Day 28

- ParticipantsOG00034
- ParticipantsOG00134
- ParticipantsOG00231
- ParticipantsOG00333
- ParticipantsOG00425

Title	Measurements
	OG000-0.02± 0.13 OG0010.02± 0.24 OG0020.01± 0.24 OG003

Day 35

- ParticipantsOG00035
- ParticipantsOG00137
- ParticipantsOG00233
- ParticipantsOG00337

Title

Denominators

Categories

ALT, Day 8

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00334
- ParticipantsOG00439

Title	Measurements
	OG0000.90± 8.33 OG001-0.90± 6.99 OG0021.18± 10.46 OG003

ALT, Day 15

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00239
- ParticipantsOG00332

ALT, Day 22

- ParticipantsOG00039
- ParticipantsOG00137
- ParticipantsOG00239
- ParticipantsOG00333

ALT, Day 28

- ParticipantsOG00039
- ParticipantsOG00132
- ParticipantsOG00236
- ParticipantsOG00330

ALT, Day 35

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00239
- ParticipantsOG00332

ALP, Day 8

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00337

ALP, Day 15

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00336

ALP, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00336

ALP, Day 28

- ParticipantsOG00041
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00336

ALP, Day 35

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00335

AST, Day 8

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00334

AST, Day 15

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00239
- ParticipantsOG00333

AST, Day 22

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00334

AST, Day 28

- ParticipantsOG00039
- ParticipantsOG00131
- ParticipantsOG00236
- ParticipantsOG00330

AST, Day 35

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00238
- ParticipantsOG00333

Creatinine phosphokinase, Day 8

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00239
- ParticipantsOG00335

Creatinine phosphokinase, Day 15

- ParticipantsOG00036
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00334

Creatinine phosphokinase, Day 22

- ParticipantsOG00039
- ParticipantsOG00137
- ParticipantsOG00240
- ParticipantsOG00334

Creatinine phosphokinase, Day 28

- ParticipantsOG00039
- ParticipantsOG00133
- ParticipantsOG00236
- ParticipantsOG00334

Creatinine phosphokinase, Day 35

- ParticipantsOG00037
- ParticipantsOG00140
- ParticipantsOG00240
- ParticipantsOG00333

LDH, Day 8

- ParticipantsOG00037
- ParticipantsOG00134
- ParticipantsOG00237
- ParticipantsOG00330

LDH, Day 15

- ParticipantsOG00035
- ParticipantsOG00131
- ParticipantsOG00238
- ParticipantsOG00332

LDH, Day 22

- ParticipantsOG00037
- ParticipantsOG00130
- ParticipantsOG00238
- ParticipantsOG00331

LDH, Day 28

- ParticipantsOG00037
- ParticipantsOG00127
- ParticipantsOG00232
- ParticipantsOG00327

LDH, Day 35

- ParticipantsOG00034
- ParticipantsOG00135
- ParticipantsOG00237
- ParticipantsOG00331

Title

Denominators

Categories

Bicarbonate, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00239
- ParticipantsOG00338
- ParticipantsOG00441

Title	Measurements
	OG0000.74± 2.69 OG0010.78± 3.01 OG0020.62± 2.40 OG003

Bicarbonate, Day 15

- ParticipantsOG00041
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Bicarbonate, Day 22

- ParticipantsOG00043
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

Bicarbonate, Day 28

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Bicarbonate, Day 35

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00336

BUN, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339

BUN, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

BUN, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00338

BUN, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

BUN, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

Calcium, Day 8

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339

Calcium, Day 15

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

Calcium, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00338

Calcium, Day 28

- ParticipantsOG00041
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Calcium, Day 35

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

Chloride, Day 8

- ParticipantsOG00042
- ParticipantsOG00142
- ParticipantsOG00241
- ParticipantsOG00341

Chloride, Day 15

- ParticipantsOG00041
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Chloride, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

Chloride, Day 28

- ParticipantsOG00042
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00340

Chloride, Day 35

- ParticipantsOG00041
- ParticipantsOG00142
- ParticipantsOG00242
- ParticipantsOG00340

Magnesium, Day 8

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00337

Magnesium, Day 15

- ParticipantsOG00039
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00336

Magnesium, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00336

Magnesium, Day 28

- ParticipantsOG00041
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00336

Magnesium, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00335

Phosphate, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00338

Phosphate, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00337

Phosphate, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00337

Phosphate, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00337

Phosphate, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00336

Potassium, Day 8

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00239
- ParticipantsOG00337

Potassium, Day 15

- ParticipantsOG00038
- ParticipantsOG00139
- ParticipantsOG00240
- ParticipantsOG00337

Potassium, Day 22

- ParticipantsOG00039
- ParticipantsOG00138
- ParticipantsOG00240
- ParticipantsOG00336

Potassium, Day 28

- ParticipantsOG00039
- ParticipantsOG00133
- ParticipantsOG00236
- ParticipantsOG00336

Potassium, Day 35

- ParticipantsOG00038
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00336

Sodium, Day 8

- ParticipantsOG00042
- ParticipantsOG00142
- ParticipantsOG00241
- ParticipantsOG00341

Sodium, Day 15

- ParticipantsOG00041
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Sodium, Day 22

- ParticipantsOG00042
- ParticipantsOG00139
- ParticipantsOG00242
- ParticipantsOG00340

Sodium, Day 28

- ParticipantsOG00042
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00340

Sodium, Day 35

- ParticipantsOG00041
- ParticipantsOG00142
- ParticipantsOG00242
- ParticipantsOG00340

Title

Denominators

Categories

Direct bilirubin, Day 8

- ParticipantsOG00037
- ParticipantsOG00135
- ParticipantsOG00237
- ParticipantsOG00332
- ParticipantsOG00437

Title	Measurements
	OG000-0.05± 0.88 OG0010.26± 0.78 OG0020.27± 0.65 OG003

Direct bilirubin, Day 15

- ParticipantsOG00035
- ParticipantsOG00131
- ParticipantsOG00239
- ParticipantsOG00331

Direct bilirubin, Day 22

- ParticipantsOG00037
- ParticipantsOG00131
- ParticipantsOG00239
- ParticipantsOG00332

Direct bilirubin, Day 28

- ParticipantsOG00038
- ParticipantsOG00128
- ParticipantsOG00232
- ParticipantsOG00328

Direct bilirubin, Day 35

- ParticipantsOG00034
- ParticipantsOG00134
- ParticipantsOG00238
- ParticipantsOG00332

Indirect bilirubin, Day 8

- ParticipantsOG00037
- ParticipantsOG00135
- ParticipantsOG00237
- ParticipantsOG00332

Indirect bilirubin, Day 15

- ParticipantsOG00035
- ParticipantsOG00131
- ParticipantsOG00239
- ParticipantsOG00331

Indirect bilirubin, Day 22

- ParticipantsOG00037
- ParticipantsOG00131
- ParticipantsOG00239
- ParticipantsOG00332

Indirect bilirubin, Day 28

- ParticipantsOG00038
- ParticipantsOG00128
- ParticipantsOG00232
- ParticipantsOG00328

Indirect bilirubin, Day 35

- ParticipantsOG00034
- ParticipantsOG00134
- ParticipantsOG00238
- ParticipantsOG00332

Serum creatinine, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339

Serum creatinine, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

Serum creatinine, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00338

Serum creatinine, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Serum creatinine, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

Total bilirubin, Day 8

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00239
- ParticipantsOG00338

Total bilirubin, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00337

Total bilirubin, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

Total bilirubin, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00239
- ParticipantsOG00337

Total bilirubin, Day 35

- ParticipantsOG00039
- ParticipantsOG00139
- ParticipantsOG00241
- ParticipantsOG00337

Uric acid, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00339

Uric acid, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Uric acid, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

Uric acid, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00338

Uric acid, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00337

Title

Denominators

Categories

HDL, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00441

Title	Measurements
	OG000-0.02± 0.14 OG0010.01± 0.19 OG0020.02± 0.19 OG003

HDL, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

HDL, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

HDL, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

HDL, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

LDL, Day 8

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00338

LDL, Day 15

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00337

LDL, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00337

LDL, Day 28

- ParticipantsOG00041
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00337

LDL, Day 35

- ParticipantsOG00039
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00336

Total cholesterol, Day 8

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339

Total cholesterol, Day 15

- ParticipantsOG00038
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

Total cholesterol, Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

Total cholesterol, Day 28

- ParticipantsOG00041
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Total cholesterol, Day 35

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

Triglycerides, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00338

Triglycerides, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00337

Triglycerides, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00337

Triglycerides, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00337

Triglycerides, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00336

Title

Denominators

Categories

Albumin, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00441

Title	Measurements
	OG0000.29± 2.03 OG0010.80± 2.40 OG0020.78± 2.72 OG003

Albumin, Day 15

- ParticipantsOG00040
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Albumin, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00242
- ParticipantsOG00338

Albumin, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

Albumin, Day 35

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00337

Total protein, Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00339

Total protein, Day 15

- ParticipantsOG00039
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Total protein, Day 22

- ParticipantsOG00042
- ParticipantsOG00138
- ParticipantsOG00241
- ParticipantsOG00338

Total protein, Day 28

- ParticipantsOG00042
- ParticipantsOG00135
- ParticipantsOG00240
- ParticipantsOG00338

Total protein, Day 35

- ParticipantsOG00040
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00337

Title

Denominators

Categories

Day 8

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00338
- ParticipantsOG00438

Title	Measurements
	OG000-0.00± 0.01 OG001-0.00± 0.01 OG0020.00± 0.01 OG003

Day 15

- ParticipantsOG00041
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00337

Day 22

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Day 28

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00242
- ParticipantsOG00337

Day 35

- ParticipantsOG00039
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00337

Title

Denominators

Categories

Day 8

- ParticipantsOG00043
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00440

Title	Measurements
	OG0000.05± 0.34 OG001-0.05± 0.38 OG002-0.02± 0.35 OG003

Day 15

- ParticipantsOG00041
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Day 22

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00338

Day 28

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00242
- ParticipantsOG00338

Day 35

- ParticipantsOG00039
- ParticipantsOG00141
- ParticipantsOG00243
- ParticipantsOG00337

Title

Denominators

Categories

Day 1, AUC 0-t

- ParticipantsOG00039
- ParticipantsOG00142
- ParticipantsOG00240
- ParticipantsOG00340

Title	Measurements
	OG0001045.8420± 978.3355 OG0012153.0075± 1835.6039 OG0022375.3150± 2285.7123 OG003

Day 28, AUC 0-t

- ParticipantsOG00037
- ParticipantsOG00142
- ParticipantsOG00240
- ParticipantsOG00340

Day 1, AUC 0-infinity

- ParticipantsOG00028
- ParticipantsOG00136
- ParticipantsOG00230
- ParticipantsOG00327

Day 28, AUC 0-infinity

- ParticipantsOG00028
- ParticipantsOG00134
- ParticipantsOG00227
- ParticipantsOG00324

Day 28, AUC 0-τ

- ParticipantsOG00035
- ParticipantsOG00142
- ParticipantsOG00239
- ParticipantsOG00337

Group IDs	Group Description	Statistical Method	Statistical Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000	Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	168.40	2-Sided	90	123.87	228.94	The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG000	Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	110.88	2-Sided	90	88.18	139.43	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG001	Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	133.11	2-Sided	90	100.55	176.21	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG001	Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Other	94.30	2-Sided	90	70.31	126.48	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG002	Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	141.63	2-Sided	90	111.20	180.39	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG002	Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	114.46	2-Sided	90	85.56	153.11	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG003	Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	167.09	2-Sided	90	120.73	231.25	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG003	Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	117.73	2-Sided	90	85.14	162.79	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.

Title

Denominators

Categories

Day 1

- ParticipantsOG00039
- ParticipantsOG00142
- ParticipantsOG00240
- ParticipantsOG00340

Title	Measurements
	OG000178.729± 179.982 OG001366.694± 322.951 OG002336.562± 298.042 OG003

Day 28

- ParticipantsOG00038
- ParticipantsOG00142
- ParticipantsOG00240
- ParticipantsOG00340

Group IDs	Group Description	Statistical Method	Statistical Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000	Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	122.22	2-Sided	90	86.94	171.80	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG001	Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	94.45	2-Sided	90	69.07	129.16	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG002	Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	114.79	2-Sided	90	91.54	143.95	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.
OG003	Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.	ANOVA	Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.	Ratio	120.30	2-Sided	90	88.66	163.23	The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.	Other	The analysis used an Estimation approach. No hypothesis testing was performed.

Title

Denominators

Categories

Day 1

- ParticipantsOG00035
- ParticipantsOG00142
- ParticipantsOG00240
- ParticipantsOG00339

Title	Measurements
	OG0003.000(2.000 to 8.000) OG0013.000(1.000 to 24.000) OG0023.000(2.000 to 8.000) OG003

Day 28

- ParticipantsOG00036
- ParticipantsOG00142
- ParticipantsOG00239
- ParticipantsOG00338

Title

Denominators

Categories

Day 1

- ParticipantsOG00028
- ParticipantsOG00136
- ParticipantsOG00230
- ParticipantsOG00327

Title	Measurements
	OG00013.4184(4.0113 to 33.0069) OG00112.1669(6.1089 to 40.6904) OG00213.3434(6.4721 to 54.7509) OG003

Day 28

- ParticipantsOG00028
- ParticipantsOG00134
- ParticipantsOG00227
- ParticipantsOG00324

Title

Denominators

Categories

Day 1

- ParticipantsOG00028
- ParticipantsOG00136
- ParticipantsOG00230
- ParticipantsOG00327

Title	Measurements
	OG000494.0236± 625.5532 OG001621.3930± 948.1533 OG0021582.0131± 2707.3466 OG003

Day 28

- ParticipantsOG00035
- ParticipantsOG00142
- ParticipantsOG00239
- ParticipantsOG00337

Title

Denominators

Categories

Day 1

- ParticipantsOG00028
- ParticipantsOG00136
- ParticipantsOG00230
- ParticipantsOG00327

Title	Measurements
	OG00012921.7880± 19802.8598 OG00115767.2219± 29059.7570 OG00238320.97415± 77339.06047 OG003

Day 28

- ParticipantsOG00028
- ParticipantsOG00134
- ParticipantsOG00227
- ParticipantsOG00324

Title

Denominators

Categories

Day 8

- ParticipantsOG00043
- ParticipantsOG00142
- ParticipantsOG00242
- ParticipantsOG00341
- ParticipantsOG00440

Title	Measurements
	OG00010.46± 2.60 OG00110.33± 2.30 OG00211.10± 2.33 OG003

Day 15

- ParticipantsOG00041
- ParticipantsOG00137
- ParticipantsOG00243
- ParticipantsOG00340

Day 22

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00243
- ParticipantsOG00338

Day 28

- ParticipantsOG00043
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

Day 35

- ParticipantsOG00041
- ParticipantsOG00141
- ParticipantsOG00243
- ParticipantsOG00339

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.997	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.581	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.987	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.850	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.843	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.961	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.939	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.966	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.075	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.700	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.732	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.552	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.196	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.393	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.775	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.603	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.108	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 8

- ParticipantsOG00043
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00440

Title	Measurements
	OG000-0.30± 2.20 OG001-1.00± 3.23 OG0020.16± 2.06 OG003

Day 15

- ParticipantsOG00041
- ParticipantsOG00136
- ParticipantsOG00242
- ParticipantsOG00338

Day 22

- ParticipantsOG00042
- ParticipantsOG00137
- ParticipantsOG00242
- ParticipantsOG00337

Day 28

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00242
- ParticipantsOG00336

Day 35

- ParticipantsOG00041
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00337

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.525	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.818	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.809	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.993	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.954	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.344	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.968	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.316	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.984	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.235	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.656	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.994	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.285	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.992	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.822	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.538	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.907	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 8

- ParticipantsOG00042
- ParticipantsOG00142
- ParticipantsOG00241
- ParticipantsOG00341
- ParticipantsOG00438

Title	Measurements
	OG00089.9± 59.63 OG00192.3± 95.57 OG00283.8± 52.19 OG003

Day 15

- ParticipantsOG00041
- ParticipantsOG00140
- ParticipantsOG00242
- ParticipantsOG00341

Day 22

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00243
- ParticipantsOG00340

Day 28

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00241
- ParticipantsOG00340

Day 35

- ParticipantsOG00042
- ParticipantsOG00141
- ParticipantsOG00241
- ParticipantsOG00341

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.982	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.677	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.688	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.903	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.945	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.949	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.924	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.394	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.687	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.568	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.486	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.973	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.739	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.731	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.991	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.994	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.963	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.929	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.970	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 8

- ParticipantsOG00040
- ParticipantsOG00142
- ParticipantsOG00237
- ParticipantsOG00339
- ParticipantsOG00436

Title	Measurements
	OG0007.2± 66.75 OG00112.2± 80.20 OG00212.3± 49.91 OG003

Day 15

- ParticipantsOG00039
- ParticipantsOG00139
- ParticipantsOG00239
- ParticipantsOG00339

Day 22

- ParticipantsOG00041
- ParticipantsOG00138
- ParticipantsOG00240
- ParticipantsOG00338

Day 28

- ParticipantsOG00041
- ParticipantsOG00136
- ParticipantsOG00239
- ParticipantsOG00338

Day 35

- ParticipantsOG00040
- ParticipantsOG00140
- ParticipantsOG00240
- ParticipantsOG00339

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.982	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.685	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.971	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.405	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.975	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.629	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.982	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.982	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.874	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.986	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.997	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.697	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

PPG, 30 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00327
- ParticipantsOG00426

Title	Measurements
	OG00012.91± 2.94 OG00112.95± 2.66 OG00213.58± 3.05 OG003

PPG, 60 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00229
- ParticipantsOG00327

PPG, 2 hour

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00340

PPI, 30 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00328

PPI, 60 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00327

PPI, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00240
- ParticipantsOG00340

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.812	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.996	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.198	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.358	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.852	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.678	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.191	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.805	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.960	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.985	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.733	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.365	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.413	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.765	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.434	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.184	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.142	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.876	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.756	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.983	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

PPG, 30 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00325
- ParticipantsOG00426

Title	Measurements
	OG0003.38± 2.85 OG0012.82± 2.40 OG0023.40± 2.52 OG003

PPG, 60 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00229
- ParticipantsOG00325

PPG, 2 hour

- ParticipantsOG00043
- ParticipantsOG00135
- ParticipantsOG00241
- ParticipantsOG00338

PPI, 30 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00328

PPI, 60 minutes

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00327

PPI, 2 hour

- ParticipantsOG00043
- ParticipantsOG00137
- ParticipantsOG00240
- ParticipantsOG00340

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.809	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.130	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.870	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.864	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.997	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.682	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.798	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.730	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.464	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.634	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.254	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.034	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.765	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.434	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.184	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.142	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.955	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.985	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.923	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.883	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.118	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.119	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.293	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.966	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.940	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.197	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.097	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.404	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 1, AUC 0-1, PPG

- ParticipantsOG00025
- ParticipantsOG00126
- ParticipantsOG00229
- ParticipantsOG00325
- ParticipantsOG00426

Title	Measurements
	OG00013.10± 2.69 OG00114.08± 3.40 OG00214.28± 3.50 OG003

Day 28, AUC 0-1, PPG

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00228
- ParticipantsOG00325

Day 1, AUC 0-2, PPG

- ParticipantsOG00027
- ParticipantsOG00127
- ParticipantsOG00228
- ParticipantsOG00327

Day 28, AUC 0-2, PPG

- ParticipantsOG00028
- ParticipantsOG00125
- ParticipantsOG00228
- ParticipantsOG00327

Day 1, AUC 0-1, PPI

- ParticipantsOG00024
- ParticipantsOG00128
- ParticipantsOG00228
- ParticipantsOG00326

Day 28, AUC 0-1, PPI

- ParticipantsOG00024
- ParticipantsOG00126
- ParticipantsOG00227
- ParticipantsOG00327

Day 1, AUC 0-2, PPI

- ParticipantsOG00026
- ParticipantsOG00128
- ParticipantsOG00226
- ParticipantsOG00328

Day 28, AUC 0-2, PPI

- ParticipantsOG00028
- ParticipantsOG00126
- ParticipantsOG00227
- ParticipantsOG00329

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.	Wilcoxon test	0.2060	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.	Wilcoxon test	0.1790	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.	Wilcoxon test	0.2741	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.	Wilcoxon test	0.6001	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.	Wilcoxon test	0.6711	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.	Wilcoxon test	0.1361	No adjustments for covariates were made.	Other
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.	Wilcoxon test	0.3369	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.	Wilcoxon test	0.0975	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.	Wilcoxon test	0.2184	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.	Wilcoxon test	0.1013	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.	Wilcoxon test	0.3286	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.	Wilcoxon test	0.5193	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.	Wilcoxon test	0.9788	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.	Wilcoxon test	0.1214	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.	Wilcoxon test	0.5751	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.	Wilcoxon test	0.2409	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.	Wilcoxon test	0.4829	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.	Wilcoxon test	0.7563	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.	Wilcoxon test	0.2907	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.	Wilcoxon test	0.7663	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI	Wilcoxon test	0.5825	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.	Wilcoxon test	0.3220	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.	Wilcoxon test	0.0564	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.	Wilcoxon test	0.1960	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.	Wilcoxon test	0.5997	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.	Wilcoxon test	0.9637	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.	Wilcoxon test	0.3240	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.	Wilcoxon test	0.8440	No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.	Wilcoxon test	0.6483	No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.	Wilcoxon test	0.6452	No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.	Wilcoxon test	0.1253	No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.	Wilcoxon test	0.2583	No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 1

Title	Measurements
	OG000320.07± 61.28 OG001320.38± 49.20 OG002319.82± 56.73 OG003328.44± 62.90 OG004296.00± 41.86

Day 28

Title	Measurements
	OG000305.70± 56.04 OG001315.97± 60.46 OG002330.15± 61.32 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.901	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.155	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.845	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.164	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.699	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.313	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.896	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.080	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.792	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.645	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 1

- ParticipantsOG00041
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00440

Title	Measurements
	OG0005.4± 3.98 OG0015.7± 5.45 OG0025.2± 5.20 OG003

Day 28

- ParticipantsOG00043
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.992	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.548	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.877	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.887	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.916	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.860	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.996	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.989	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.763	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Title

Denominators

Categories

Day 1

- ParticipantsOG00041
- ParticipantsOG00140
- ParticipantsOG00241
- ParticipantsOG00339
- ParticipantsOG00440

Title	Measurements
	OG00038.3± 38.15 OG00131.8± 46.38 OG00231.2± 35.46 OG003

Day 28

- ParticipantsOG00043
- ParticipantsOG00136
- ParticipantsOG00241
- ParticipantsOG00338

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.810	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.753	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.404	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.671	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG001	Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	1.000	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.622	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.332	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.998	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.994	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG002	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.979	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG003	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.993	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority
OG000 OG004	ANOVA	Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.	0.999	Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.	Superiority

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases