Trial Outcomes & Findings for The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population (NCT NCT02119325)

NCT ID: NCT02119325

Last Updated: 2015-05-15

Results Overview

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
• Results posted on: 2015-05-15

Participant Flow

Participants were mainly recruited from the study site database.

Of the 210 participants screened, 114 participants were not randomised. The reasons for the same were: not meeting study criteria (n=42), lost to follow-up (n=5), and other reasons (n=67).

Participant milestones

Measure	Sequence 1 Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.	Sequence 2 Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Period 1 STARTED	48	48
Period 1 COMPLETED	48	48
Period 1 NOT COMPLETED	0	0
Washout Period 1 STARTED	48	48
Washout Period 1 COMPLETED	48	47
Washout Period 1 NOT COMPLETED	0	1
Period 2 STARTED	48	47
Period 2 COMPLETED	48	47
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Sequence 1 Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.	Sequence 2 Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Washout Period 1 Adverse Event	0	1

Baseline Characteristics

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Baseline characteristics by cohort

Measure	Overall Participants n=96 Participants
Age, Continuous	33.9 Years STANDARD_DEVIATION 7.42 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	96 Participants n=93 Participants
Impaired fasting glucose (IFG) status IFG	26 participants n=93 Participants
Impaired fasting glucose (IFG) status No IFG	70 participants n=93 Participants

PRIMARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Glucose in IFG Status Participants	42.76 mg/dL Standard Deviation 24.229	47.40 mg/dL Standard Deviation 23.233

PRIMARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Triglyceride in IFG Status Participants	121.07 mg/dL Standard Deviation 46.484	127.85 mg/dL Standard Deviation 72.565

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Glucose in Overweight Healthy Participants	38.98 mg/dL Standard Deviation 17.687	43.64 mg/dL Standard Deviation 19.220

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for Glucose in Overweight Healthy Participants	27163.93 mg*min/dL Standard Deviation 2804.549	27329.59 mg*min/dL Standard Deviation 3040.290

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for Glucose in Overweight Healthy Participants	25.74 minutes Standard Deviation 15.710	25.78 minutes Standard Deviation 11.972

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Triglyceride in Overweight Healthy Participants	126.20 mg/dL Standard Deviation 51.959	119.84 mg/dL Standard Deviation 56.151

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for Triglycerides in Overweight Healthy Participants	59829.76 mg*min/dL Standard Deviation 27022.972	60488.97 mg*min/dL Standard Deviation 29642.057

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for Triglycerides in Overweight Healthy Participants	220.32 minutes Standard Deviation 37.115	218.75 minutes Standard Deviation 30.444

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for RLP Cholesterol in IFG Status Participants	0.82 mmole/L Standard Deviation 0.780	1.30 mmole/L Standard Deviation 1.265

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for RLP Cholesterol in IFG Status Participants	1765.27 mmole*min/L Standard Deviation 237.951	1759.01 mmole*min/L Standard Deviation 230.544

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for RLP Cholesterol in IFG Status Participants	124.23 minutes Standard Deviation 84.068	125.00 minutes Standard Deviation 77.006

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for RLP Cholesterol in Overweight Healthy Participants	0.97 mmole/L Standard Deviation 1.009	1.33 mmole/L Standard Deviation 1.783

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for RLP Cholesterol in Overweight Healthy Participants	1856.49 mmole*min/L Standard Deviation 1049.372	1845.29 mmole*min/L Standard Deviation 904.018

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for RLP Cholesterol in Overweight Healthy Participants	116.84 minutes Standard Deviation 77.088	130.26 minutes Standard Deviation 76.507

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Insulin in IFG Status Participants	190.90 µIU/mL Standard Deviation 75.471	214.90 µIU/mL Standard Deviation 84.080

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for Insulin in IFG Status Participants	24920.06 µIU*min/mL Standard Deviation 10299.888	27066.11 µIU*min/mL Standard Deviation 10666.718

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG

Outcome measures

Measure	Test n=26 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=26 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for Insulin in IFG Status Participants	38.46 minutes Standard Deviation 23.949	39.23 minutes Standard Deviation 19.115

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Cmax for Insulin in Overweight Healthy Participants	188.84 µIU/mL Standard Deviation 87.184	213.42 µIU/mL Standard Deviation 100.641

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
AUC for Insulin in Overweight Healthy Participants	21963.63 µIU*min/mL Standard Deviation 10310.800	25089.69 µIU*min/mL Standard Deviation 13421.113

SECONDARY outcome

Timeframe: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes

Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.

To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults

Outcome measures

Measure	Test n=95 Participants Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).	Placebo n=96 Participants No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Tmax for Insulin in Overweight Healthy Participants	35.58 minutes Standard Deviation 24.176	36.41 minutes Standard Deviation 21.048

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test n=96 participants at risk Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).	Placebo n=96 participants at risk No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
Gastrointestinal disorders Diarrhoea	0.00% 0/96 • Adverse events were recorded from the start of the investigational product, and until one day following last administration of the investigational product.	1.0% 1/96 • Number of events 1 • Adverse events were recorded from the start of the investigational product, and until one day following last administration of the investigational product.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER