| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12, HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean., Baseline (Week 0) and Week 12 | Secondary: Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24, HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values., Baseline (Week 0) up to Week 24|Change From Baseline in FPG at Week 12, The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean., Baseline (Week 0) and Week 12|Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24, The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values., Baseline (Week 0) up to Week 24|Number of Participants Who Were HbA1c Responders at Week 12, HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of \<=6.5%, \<7% and HbA1c reduction of \>=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement., Week 12|Number of Participants of FPG Responders at Week 12, The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of \<7 mmol/L and FPG reduction value of \>=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement., Week 12|Change From Baseline in Fructosamine at Week 12, The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean., Baseline (Week 0) and Week 12|Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24, The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values., Baseline (Week 0) up to Week 24|Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12, The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean., Baseline (Week 0) and Week 12|Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8, The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values., Baseline (Week 0) up to Week 24|Change From Baseline in Pro-insulin at Week 16, 20 and 24., The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values., Baseline (Week 0) up to Week 24|Change From Baseline in Pro-insulin to Insulin Ratio at Week 12, The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean., Baseline (Week 0) and Week 12|Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8, The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean., Baseline (Week 0) and Week 4 and 8|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia, 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. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia., Up to Week 25|Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe, 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. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities., Up to Week 25|Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy, The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline \>30 beats per minute (bpm) and \<50 or \>120 bpm; SBP increase or decrease from Baseline \>30 millimeter of mercury (mmHg) in the same posture and \>170 or \<100 mmHg; increase or decrease from Baseline \>20 mmHg in same posture and \>110 or \<50 mmHg., Baseline (Week 0) up to Week 24|Change From Baseline in Body Weight Over Time, The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values., Baseline (Week 0) and Week -5 to 25 (Follow-up)|Change From Baseline in Body Mass Index (BMI) Over Time, BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values., Baseline (Week 0) and Week -5 to 25 (Follow-up)|Change From Baseline in Waist Circumference and Hip Circumference Over Time, Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values., Baseline (Week 0) up to Week 24|Mean Change From Baseline in Waist to Hip Ratio Over Time, Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values., Baseline (Week 0) up to Week 24|Change From Baseline in 12-lead ECG Over Time, 12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values., Baseline (Week 0) up to Week 24|Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy, The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase (\[LDH\] if \>2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized., Up to Week 24|Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy, The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized., Up to Week 24|Number of Participants With Abnormal Urinalysis Dipstick Result, The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25)., Up to Follow-up (Week 25)|Number of Participants With Urinalysis Microscopic Result, The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25)., Up to Follow-up (Week 25)|Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN, A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals., Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20|Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK, A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals., Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
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| Locations: |
GSK Investigational Site, Long Beach, California, 90806, United States|GSK Investigational Site, Pasadena, California, 91105, United States|GSK Investigational Site, Denver, Colorado, 80220, United States|GSK Investigational Site, Hollywood, Florida, 33021, United States|GSK Investigational Site, Miami, Florida, 33126, United States|GSK Investigational Site, Atlanta, Georgia, 30308, United States|GSK Investigational Site, Marietta, Georgia, 30066, United States|GSK Investigational Site, Honolulu, Hawaii, 96813, United States|GSK Investigational Site, Chicago, Illinois, 60607, United States|GSK Investigational Site, Indianapolis, Indiana, 46202, United States|GSK Investigational Site, Sunset, Louisiana, 70584, United States|GSK Investigational Site, Oxon Hill, Maryland, 20745, United States|GSK Investigational Site, Las Vegas, Nevada, 89106, United States|GSK Investigational Site, Pahrump, Nevada, 89048, United States|GSK Investigational Site, Albany, New York, 12208, United States|GSK Investigational Site, Buffalo, New York, 14209, United States|GSK Investigational Site, Johnson City, New York, 13790, United States|GSK Investigational Site, Rochester, New York, 14642, United States|GSK Investigational Site, Syracuse, New York, 13210, United States|GSK Investigational Site, Durham, North Carolina, 27710, United States|GSK Investigational Site, Raleigh, North Carolina, 27612, United States|GSK Investigational Site, Cincinnati, Ohio, 45246, United States|GSK Investigational Site, Kettering, Ohio, 45429, United States|GSK Investigational Site, Jefferson Hills, Pennsylvania, 15025, United States|GSK Investigational Site, Sewickley, Pennsylvania, 15143, United States|GSK Investigational Site, Columbia, South Carolina, 29201, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, Arlington, Texas, 76017, United States|GSK Investigational Site, Dallas, Texas, 75230, United States|GSK Investigational Site, Dallas, Texas, 75246, United States|GSK Investigational Site, San Antonio, Texas, 78237, United States|GSK Investigational Site, Salt Lake City, Utah, 84102, United States|GSK Investigational Site, Burke, Virginia, 22015, United States|GSK Investigational Site, Bellingham, Washington, 98226, United States|GSK Investigational Site, Tacoma, Washington, 98403, United States|GSK Investigational Site, Vancouver, Washington, 98664, United States|GSK Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|GSK Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|GSK Investigational Site, Bay Roberts, Newfoundland and Labrador, A0G 1G0, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3T1, Canada|GSK Investigational Site, Toronto, Ontario, M4R 2G4, Canada|GSK Investigational Site, Toronto, Ontario, M9W 4L6, Canada|GSK Investigational Site, Waterloo, Ontario, N2J 1C4, Canada|GSK Investigational Site, Gatineau, Quebec, J8Y 6S8, Canada|GSK Investigational Site, Mirabel, Quebec, J7J 2K8, Canada|GSK Investigational Site, Pointe-Claire, Quebec, H9R 4S3, Canada|GSK Investigational Site, Sainte-Foy, Quebec, G1W 4R4, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 4J6, Canada|GSK Investigational Site, Brno, 656 51, Czechia|GSK Investigational Site, Ceske Budejovice, 370 87, Czechia|GSK Investigational Site, Cheb, 350 02, Czechia|GSK Investigational Site, Liberec, 46004, Czechia|GSK Investigational Site, Praha 2, 128 21, Czechia|GSK Investigational Site, Praha 5, 150 05, Czechia|GSK Investigational Site, Praha 5, 158 00, Czechia|GSK Investigational Site, Trebic, 674 01, Czechia|GSK Investigational Site, Helsinki, 00260, Finland|GSK Investigational Site, Kuopio, 70210, Finland|GSK Investigational Site, Oulu, 90100, Finland|GSK Investigational Site, Bammental, Baden-Wuerttemberg, 69245, Germany|GSK Investigational Site, Deggingen, Baden-Wuerttemberg, 73326, Germany|GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, 69120, Germany|GSK Investigational Site, Kippenheim, Baden-Wuerttemberg, 77971, Germany|GSK Investigational Site, Koenigsfeld, Baden-Wuerttemberg, 78126, Germany|GSK Investigational Site, Offenburg, Baden-Wuerttemberg, 77654, Germany|GSK Investigational Site, Sinsheim, Baden-Wuerttemberg, 74889, Germany|GSK Investigational Site, Stockach, Baden-Wuerttemberg, 78333, Germany|GSK Investigational Site, Weinheim, Baden-Wuerttemberg, 69469, Germany|GSK Investigational Site, Haag, Bayern, 83527, Germany|GSK Investigational Site, Hoehenkirchen-Siegertsbrunn, Bayern, 85635, Germany|GSK Investigational Site, Bad Kreuznach, Hessen, 55545, Germany|GSK Investigational Site, Hirschhorn, Hessen, 69434, Germany|GSK Investigational Site, Kelkheim, Hessen, 65779, Germany|GSK Investigational Site, Offenbach, Hessen, 63067, Germany|GSK Investigational Site, Offenbach, Hessen, 63073, Germany|GSK Investigational Site, Bad Lauterberg, Niedersachsen, 37431, Germany|GSK Investigational Site, Lueneburg, Niedersachsen, 21335, Germany|GSK Investigational Site, Tostedt, Niedersachsen, 21255, Germany|GSK Investigational Site, Ingelheim, Rheinland-Pfalz, 55218, Germany|GSK Investigational Site, Mainz, Rheinland-Pfalz, 55116, Germany|GSK Investigational Site, Rhaunen, Rheinland-Pfalz, 55624, Germany|GSK Investigational Site, Speyer, Rheinland-Pfalz, 67346, Germany|GSK Investigational Site, Dresden, Sachsen, 01129, Germany|GSK Investigational Site, Dresden, Sachsen, 01219, Germany|GSK Investigational Site, Freital, Sachsen, 01705, Germany|GSK Investigational Site, Pirna, Sachsen, 01796, Germany|GSK Investigational Site, Schmiedeberg, Sachsen, 01762, Germany|GSK Investigational Site, Athens, 115 26, Greece|GSK Investigational Site, Heraklion, Crete, 71409, Greece|GSK Investigational Site, Lavrio, 19500, Greece|GSK Investigational Site, Melissia, 15127, Greece|GSK Investigational Site, Thessaloniki, 546 42, Greece|GSK Investigational Site, Thessaloniki, 551 32, Greece|GSK Investigational Site, Thessaloniki, 564 29, Greece|GSK Investigational Site, Thessaloniki, 564 34, Greece|GSK Investigational Site, Jelgava, LV 3001, Latvia|GSK Investigational Site, Ogre, LV 5001, Latvia|GSK Investigational Site, Riga, LV 1002, Latvia|GSK Investigational Site, Riga, LV1002, Latvia|GSK Investigational Site, Riga, LV1079, Latvia|GSK Investigational Site, Talsi, LV 3201, Latvia|GSK Investigational Site, Valmiera, LV 4201, Latvia|GSK Investigational Site, Ponce, 00716, Puerto Rico|GSK Investigational Site, Brasov, 500366, Romania|GSK Investigational Site, Bucharest, 020045, Romania|GSK Investigational Site, Bucharest, 020475, Romania|GSK Investigational Site, Göteborg, SE-413 45, Sweden|GSK Investigational Site, Malmö, SE-205 02, Sweden|GSK Investigational Site, Stockholm, SE-182 88, Sweden
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