Name of Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA

German Competent Authority: Bundesamt für Arzneimittel und Medizinprodukte BfArM – Vorlagenummer: 4035105

Sponsor’s Protocol Code Number: 0431-082

EudraCT Number: 2008-006719-20

Protocol Title:

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Protocol-Amendment(s): # 1 dated 13-Sep-2010 # 2 dated 03-Apr-2012 # 3 dated 05-Sep-2013 # 4 dated 12-Feb-2014

Name of Finished Product: JANUVIA® Name of Active Substance: Sitagliptin Date of Marketing Authorization: 21-March-2007 Marketing Authorization Number(s): EU/1/07/383/001-024

Name of Finished Product: JANUMET® Name of Active Substance: Sitagliptin-Metformin Date of Marketing Authorization: 16-July-2008 Marketing Authorization Number(s): EU/1/08/455/001-022 1 PRODUCT: MK-0431 CLINICAL STUDY REPORT PN-082 PAGE 2 28 SEPTEMBER 2015

2 SYNOPSIS

SPONSOR: Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc. COMPOUND MK-0431 NAME: INDICATION: Type 2 diabetes mellitus PROTOCOL TECOS: A Randomized, Placebo Controlled Clinical Trial to TITLE: Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control TRIAL Protocol Number: P082 IDENTIFIERS: Clinical Phase: III US IND Number: 65495

TRIAL CENTERS: This trial was conducted at 674 sites in 38 countries: 118 in the United States, 23 in Argentina, 24 in Australia, 8 in Belgium, 15 in Brazil, 16 in Bulgaria, 12 in Chile, 9 in China, 12 in Colombia, 25 in the Czech Republic, 26 in Canada, 9 in Estonia, 6 in Finland, 7 in France, 30 in Germany, 10 in Hong Kong, 12 in Hungary, 17 in Israel, 15 in Italy, 22 in India, 15 in the Republic of Korea, 11 in Latvia, 12 in Lithuania, 11 in Malaysia, 17 in the Netherlands, 6 in Norway, 9 in New Zealand, 24 in Poland, 14 in Romania, 26 in the Russian Federation, 3 in Singapore, 7 in Slovakia, 21 in South Africa, 13 in Spain, 9 in Sweden, 13 in Taiwan, 10 in Turkey, and 37 in the United Kingdom. The list of investigators and other important trial participants, and investigator qualifications are in [16.1.4].

DESIGN: This was a multinational, placebo-controlled, double-blind, randomized, parallel-group pragmatic clinical trial. Eligible patients had T2DM with an HbA1c of ≥6.5% (48 mmol/mol) and ≤8.0% (64 mmol/mol) on stable doses of either monotherapy or dual combination therapy with metformin, pioglitazone, or a sulfonylurea, or, after a protocol amendment [16.1.1.2], on stable doses of insulin (i.e., ±20% of the scheduled total daily insulin dose) either alone or in combination with metformin, for at least 3 months (i.e., no adjustments to oral antihyperglycemic therapy in the past 3 months). In addition, patients were at least 50 years of age with preexisting documented vascular disease in the coronary, cerebral, or peripheral arteries. A total of 14,735 patients were randomly allocated to treatment with either sitagliptin once daily or placebo in a 1:1 ratio; of these, 14,671 were included in the intent to treat (ITT) population. For patients with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2, the starting dose of sitagliptin or placebo was 100 mg q.d.; for

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patients with eGFR 30 to <50 mL/min/1.73 m2, the starting dose of sitagliptin or matching placebo was 50 mg q.d. If not stopped early as a result of interim analyses, the study was planned to continue until 1300 patients with a confirmed cardiovascular (CV) event in the primary composite endpoint occurred and at least 36 months had elapsed from the time that at least 2000 patients on metformin monotherapy at baseline had been randomized to blinded study drug. The study was monitored by an independent Data and Safety Monitoring Board (DSMB). The DSMB charter and DSMB statistical analysis plan are provided in [16.1.1.7], and [16.1.9.4] , respectively. An independent Clinical Events Classification Committee (CECC) reviewed and adjudicated each suspected clinical endpoint event and were blinded to treatment. It was anticipated that patients would see their usual care physicians at least twice per year, since they were all high-risk (due to the combination of vascular disease and diabetes requiring drug therapy). The study follow-up was a blend of study visits and phone calls during the double-blind placebo-controlled treatment period, which was anticipated to provide approximately 4-5 years of patient follow-up. For the duration of the study, the CECC adjudication forms and supporting documents pertaining to events were collated by patient number and kept in a locked, confidential archive at DCRI. The CECC document packets for each event were forwarded to the Sponsor after database lock. A description of the organization and membership of the CECC is found in the CECC charter, provided in [16.1.1.8]. For additional information about trial design, see the Protocol in [16.1.1]. Sample case report forms are in [16.1.2]. Randomization schema by center is in [16.1.7].

Planned duration of main Event-driven trial (1300 PP events phase: in the primary composite endpoint) Approximately 4 – 5 years Planned duration of run-in Not applicable phase:

Planned duration of extension Not applicable phase:

Objectives The primary objective was to compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin (or other dipeptidyl peptidase-4 inhibitors [DPP-4 inhibitors] or glucagon-like peptide-1 [GLP-1] analogues) on CV outcomes as measured by the time to first event in the primary CV composite

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endpoint of CV-related death, nonfatal myocardial infarction (MI), nonfatal stroke, or unstable angina requiring hospitalization. Secondary objectives compared sitagliptin as part of usual care vs. usual care without sitagliptin on the following: (1) The time to first event in a secondary composite CV endpoint of CV-related death, nonfatal MI, and nonfatal stroke; (2) The time to first event for each of the following individual CV endpoints: confirmed CV-related death, MI (fatal + nonfatal), stroke (fatal + nonfatal), and unstable angina requiring hospitalization; (3) All-cause mortality; (4) Hospital admissions for congestive heart failure (CHF); (5) Change from baseline in HbA1c over time; (6) Change in renal function (based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method); (7) In patients not receiving insulin at baseline, time to initiation of chronic insulin therapy. Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months; (8) In patients not receiving insulin at baseline, time to addition of first cointerventional agent (i.e., next oral antihyperglycemic agent (AHA) or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months); (9) Medical resource utilization during the trial (e.g., hospitalizations and outpatient physician visits).

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Hypotheses Hypothesis a: Sitagliptin, when used as part of usual care, is noninferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint. Hypothesis b: If hypothesis a is satisfied: Sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint A sequential analysis strategy for the primary endpoint of MACE plus and the key secondary endpoint of MACE was included in the Statistical Analysis Plan (Section 5.3, Statistical Analysis Plan (SAP), Version 3.0, 10 September 2014). Each sequential step was tested at a 1-sided significance level of 0.025. If the success criterion for a given hypothesis test was not met, no following hypotheses were to be formally tested. • Non-inferiority of sitagliptin vs. placebo for the primary endpoint MACE plus in the Per Protocol (PP) population. • Non-inferiority of sitagliptin vs. placebo for the secondary endpoint MACE in the PP population. • Superiority of sitagliptin vs. placebo for the primary endpoint MACE plus in the ITT population. • Superiority of sitagliptin vs. placebo for the secondary endpoint MACE in the ITT population.

Treatments groups Treatment 1 Sitagliptin tablet taken orally once daily in the morning 7,266 Treatment 2 Matching placebo tablet taken orally once daily in the morning 7,274

Total APaT population 14,540 Starting dose – eGFR Sitagliptin or placebo 100 mg q.d. based on eGFR ≥50 mL/min/1.73 m2 Sitagliptin – 6,575 value provided to Placebo – 6,602 IVRSa, b All patients – 13,177 eGFR = 30 to Sitagliptin or placebo 50 mg q.d. <50 mL/min/1.73 m2 Sitagliptin – 691 Placebo – 671 All patients – 1,362

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a There were two different sources of eGFR data: initial study drug dosage and subsequent dose adjustments were based on eGFR values that the site provided to the IVRS, and the site also entered eGFR data in the eCRF. There were 3 patients, for whom the eCRF data show eGFR <30 mL/min/1.73m2 (actual values were 29, 29, and23 mL/min/1.73m2): 1patient in the sitagliptin group, and 2 patients in the placebo group. However, for these 3 patients, the site in fact entered an eGFR of “≥30–<50 mL/min/1.73m2” in IVRS, and hence the 3 patients are among those assigned to a study drug dose of 50 mg. As subsequent eGFR data reported to the IVRS, 1 of the 3 patients was subsequently changed to a study drug dose of 25 mg. b One patient in the placebo group was missing the initial eGFR value reported to the IVRS and so had no dose assigned. This patient was also missing the baseline eGFR in the eCRF. DOSAGE/ The bulk product descriptions and manufacturing lot numbers of FORMULATION sitagliptin and placebo that were shipped to study sites are listed in NUMBERS [16.1.6]. Bottle defect in A physical defect was observed in one lot of 120cc high-density some clinical polyethylene (HDPE) bottles (LOT WL00036788) used for supplies (not packaging some clinical supplies that were used in this study. An distributed to inspection/replacement plan was implemented to identify potentially patients): affected bottles and removed them from the clinical supply chain. Of the 59,400 bottles potentially affected, 59,390 bottles were inspected and 262 bottles were found to have holes as defects. Not all bottles potentially affected were inspected because some bottles were returned prior to the defect being identified. Stability assessments did not identify any potential impact to drug potency, dissolution, disintegration or degradate levels which were likely to cause patients to have experienced differences in the effects of the study drug or to impact the measured outcomes of the study due to the bottle defect. Affected supplies were not distributed to patients in this study. The study blinding was not broken during implementation of the plan and no patients were excluded from analysis due to the bottle defect.

Endpoints and Primary Time to first MACE plus Time from randomization definitions endpoint to first confirmed event in the primary composite CV endpoint of MACE plus (CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization)

Key Time to first MACE Time from randomization secondary to first confirmed event in endpoint the composite CV endpoint of MACE

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(CV-related death, nonfatal MI, or nonfatal stroke)

Secondary Time to first confirmed event Time from randomization endpoints for individual CV endpoints to each of the components of the primary composite endpoint (CV-related death, MI [fatal + nonfatal], stroke [fatal +nonfatal], and unstable angina requiring hospitalization)

Time to all-cause mortality Time from randomization to death due to any cause

Time to congestive heart Time from randomization failure (CHF) to hospital admission for confirmed CHF

Change from baseline over Urinary albumin to time creatinine ratio eGFR (MDRD) HbA1c (% and mmol/mol)

Time to initiation of chronic Time from randomization insulin therapy to the start of the first instance of chronic insulin therapy, defined as continuous use longer than three months in patients not receiving insulin at baseline

Time to initiation of first Time from randomization cointerventional agent to the start of the first instance of initiation of a cointerventional agent, i.e. next oral AHA or chronic insulin therapy in patients not receiving insulin at baseline

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Hospitalizations Count of hospitalizations for any reason

Database lock 31-MAR- Trial status 16-DEC-2008 2015 (first patient first visit) to 30-MAR-2015 (last patient last visit) ANALYSIS: The Statistical Analysis Plan is provided in [16.1.9.1]. Additional analyses and changes to the proposed analyses and data handling specification in the SAP are described in a supplemental SAP [16.1.9.3] Analysis For all time-to-event analyses (defined as [first event date – description randomization date] +1 in patients with events and as [appropriate censoring date based on analytic population – randomization date] +1 in patients without events), the treatment groups were analyzed using a Cox proportional hazards model that included treatment as an explanatory factor and region as a stratification factor unless specified otherwise. The Efron method was used for handling ties. P-value and confidence intervals for the HR were based on the Wald statistic.

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RESULTS Study Patients A total of 14,735 patients underwent randomization from December 2008 through July 2012. Of these patients, 14,671 were included in the ITT population, with 7,332 assigned to receive sitagliptin and 7,339 assigned to receive placebo. The study was closed in March 2015, after the requisite minimum of 1300 patients were confirmed to have had a primary composite outcome. Median follow-up was 3.0 years (interquartile range, 2.3 to 3.8; maximum, 5.7). Overall, 95.1% of patients in the sitagliptin group and 94.1% of those in the placebo group completed the study, with 26.1% and 27.5% of all study patients, respectively, discontinuing study medication prematurely. The sitagliptin and placebo groups were well balanced with respect to demographic characteristics and the use of antihyperglycemic agents and secondary cardiovascular prevention medications. At baseline, mean (SD) HbA1c was 7.2% (0.5%), and patients had been living with diabetes for a mean of 11.6 years (8.1) (ITT population). Disposition of patients is summarized in the CONSORT diagram:

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14,735 Randomized

64 Excluded from all analyses 11 Did not consent 53 GCP deviations (at 1 site) 14,671 Included in the ITT Population

7,332 Randomly assigned to receive sitagliptin 7,339 Randomly assigned to receive placebo 66 Did not receive any dose of study drug 65 Did not receive any dose of study drug

6,972 (95.1%) Completed study1 6,905 (94.1%) Completed study1 1,650 Prematurely discontinued drug 1,706 Prematurely discontinued drug

12 (0.2%) Non-completers who had primary 14 (0.2%) Non-completers who had primary endpoint prior to discontinuation endpoint prior to discontinuation 0 Lost to follow-up 3 Lost to follow-up 12 Withdrew consent 11 Withdrew consent

2 10 Prematurely discontinued drug 12 Prematurely discontinued drug Vital status post LTFU/WDC Vital status post LTFU/WDC2 348 (4.7%) Non-completers 420 (5.7%) Non-completers LTFU WDC LTFU WDC 61 Lost to follow-up 68 Lost to follow-up Died 2 22 Died 1 20 3 Found alive 27 157 287 Withdrew consent 352 Withdrew consent Found alive3 32 165 Not found 32 120 251 Prematurely discontinued drug 302 Prematurely discontinued drug Not found 38 178

1: Patients who completed study alive, or died and were not at a final status of lost to follow-up (LTFU) or withdrew consent (WDC) prior to death are counted as completers. 2: Vital status summary is among all non-completers regardless of primary endpoint status prior to LTFU/WDC. 3: Found alive after LTFU/WDC on or after 05 May 2014.

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RESULTS Primary and Secondary Outcomes Analyses Per Protocol Sitagliptin Placebo N=7,257 N=7,266 Events . per Events. 100 per 100 person person- Hazard Ratio n (%) -year n (%) year (95%CI) P Value CV outcomes Primary composite outcome – MACE plus (non inferiority)1 695 (9.6) 3.73 695 (9.6%) 3.82 0.98 (0.88, 1.09) <.001 Secondary composite outcome – MACE (non inferiority)1 609 (8.4) 3.24 602 (8.3) 3.28 0.99 (0.89, 1.11) <.001 Secondary outcomes CV death2 250 (3.4) 1.29 235 (3.2) 1.24 1.04 (0.87, 1.24) 0.654 Hospitalization for unstable angina3 104 (1.4) 0.54 114 (1.6) 0.61 0.90 (0.69, 1.18) 0.445 Fatal or nonfatal MI4 269 (3.7) 1.42 276 (3.8) 1.49 0.96 (0.81, 1.13) 0.604 Fatal or nonfatal stroke5 157 (2.2) 0.82 165 (2.3) 0.88 0.93 (0.75, 1.16) 0.544 315 All cause mortality6 342 (4.7%) 1.77 (4.3%) 1.67 1.06 (0.91, 1.24) 0.435 Hospitalization for CHF7 200 (2.8) 1.05 202 (2.8) 1.08 0.98 (0.81, 1.19) 0.858 Hospitalization for CHF or CV death8 415 (5.7) 2.18 406 (5.6) 2.18 1.01 (0.88, 1.16) 0.889 Non-CV outcomes Acute pancreatitis9 20 (0.3) 0.10 11 (0.2%) 0.06 1.80 (0.86, 3.76) 0.118 Charter-defined malignancy10 248 (3.4) 1.30 260 (3.6%) 1.40 0.93 (0.78, 1.10) 0.384 Charter-defined pancreatic malignancy11 9 (0.1) 0.05 10 (0.1) 0.05 0.91 (0.37, 2.25) 0.846 Severe hypoglycemia12 144 (2.0) 0.77 125 (1.7) 0.68 1.13 (0.89, 1.44) 0.310 Source, PP results – 1 Table 14.2.5, 2 Table 14.2.20, 3 Table 14.2.24, 4 Table 14.2.28, 5 Table 14.2.32, 6Table 14.2.36, 7Table 14.2.47, 8Table 14.2.55, 9Table 14.3.34, 10Table 14.3.42, 11Table 14.3.50, 12Table 14.3.54.

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Intent to Treat Sitagliptin Placebo N=7,332 N=7,339 Events . per Events. 100 per 100 person person- Hazard Ratio n (%) -year n (%) year (95%CI) P Value CV outcomes Primary composite outcome – MACE plus (non inferiority)13 839 (11.4) 4.06 851 (11.6)0 4.17 0.98 (0.89, 1.08) <.001 MACE plus (superiority)14 839 (11.4) 4.06 851 (11.6)0 4.17 0.98 (0.89, 1.08) 0.645 Secondary composite outcome – MACE (non inferiority)13 745 (10.2) 3.58 746 (10.2) 3.62 0.99 (0.89, 1.10) <.001 MACE (superiority)14 745 (10.2) 3.58 746 (10.2) 3.62 0.99 (0.89, 1.10) 0.844 Secondary outcomes CV death15 380 (5.2) 1.72 366 (5.0) 1.67 1.03 (0.89, 1.19) 0.711 Hospitalization for unstable angina16 160 (1.6) 0.54 129 (1.8) 0.61 0.90 (0.70, 1.16) 0.419 Fatal or nonfatal MI17 300 (.4.1) 1.42 316 (4.3) 1.51 0.95 (0.81, 1.11) 0.487 Fatal or nonfatal stroke18 178 (2.4) 0.83 183 (2.5) 0.87 0.97 (0.79, 1.19) 0.760 All cause mortality19 547 (7.5%) 2.48 537 (7.3%) 2.45 1.01 (0.90, 1.140 0.875 Hospitalization for CHF20 228 (3.1) 1.07 229 (3.1) 1.09 1.00 (0.83, 1.20) 0.983 Hospitalization for CHF or CV death21 538 (7.3) 2.54 525 (7.2) 2.50 1.02 (0.90, 1.15) 0.743 Non-CV outcomes Acute pancreatitis22 23 (0.3%) 0.11 12 (0.2%) 0.06 1.93 (0.96, 3.88) 0.065 Charter-defined malignancy23 268 (3.7) 1.25 290 (4.0%) 1.37 0.91 (0.77, 1.08) 0.272 Charter-defined pancreatic malignancy24 9 (0.1) 0.04 14 (0.2) 0.07 0.66 (0.28, 1.51) 0.322 Severe hypoglycemia25 160 (2.2) 0.78 43 (1.9) 0.70 1.12 (0.89, 1.40) 0.334 Source: ITT results – 13 Table 14.2.6, 14 Table 14.2.7, 15 Table 14.2.21, 16 Table 14.2.25, 17 Table 14.2.29, 18 Table 14.2.33, 19 Table 14.2.37, 20 Table 14.2.48, 21 Table 14.2.56, 22 Table 14.3.35, 23 Table 14.3.43, 24 Table 14.3.52, 25 Table 14.3.55.

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Safety Results

Prespecified diabetes complications and expected events There was no notable difference between sitagliptin and placebo with respect to the incidence of any prespecified diabetes complications, based on the prospectively planned collection of all events of peripheral arterial disease, amputation, gangrene, hyperglycemia requiring hospitalization, hypoglycemia requiring assistance, blindness due to diabetes, diabetic neuropathy, retinopathy, microalbuminuria, renal failure, infections, gastrointestinal (GI) conditions associated with diabetes, pancreatitis, and metabolic conditions associated with diabetes. There was no apparent difference between treatment groups with respect to the percentage of patients having 1, 2, or ≥3 post baseline diabetes complications. There was no notable difference between sitagliptin and placebo with respect to the incidence of any prespecified expected events, not classified as diabetic complications. These events included blindness not due to diabetes, percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation/flutter, ventricular fibrillation/tachycardia requiring intervention, deep vein thrombosis, pulmonary embolism, shock/hypotension, cardiac catheterization, macroalbuminuria, and allergic reaction attributed to study drug.

Adverse event data includes events that were not on the Protocol's clinical events list which met SAE reporting criteria, and/or any AEs that resulted in early cessation of study medication. Other non-serious AEs were not captured in this trial. The clinical events listed in the Protocol were collected and presented separately from the adverse event data. Estimates reflect the difference in percentage of subjects with the event (sitagliptin vs. placebo). 95% confidence intervals are based on Miettinen & Nurminen method in accordance with the statistical analysis plan. P values are based on Fisher's Exact mid-P in accordance with the statistical analysis plan.

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Treatment Emergent Adverse Events – APaT

Sitagliptin Placebo Estimate Subjects with one or more: N=7,266 N=7,274 (95% CI) P value

Adverse event (AE) 1,015 (14.0%) 995 (13.7%) 0.29 (-0.83, 1.41) 0.606

Serious adverse event (SAE) 928 (12.8%) 909 (12.5%) 0.28 (-0.81, 1.36) 0.609

AE related to study treatment 101 (1.4%) 111 (1.5%) -0.14 (-0.53, 0.26) 0.512

AE with fatal outcome 54 (0.7%) 57 (0.8%) -0.04 (-0.33, 0.25) 0.812

AE resulting in permanent treatment discontinuation 176 (2.4%) 173 (2.4%) 0.04 (-0.46, 0.54) 0.850

AE related to study treatment resulting in permanent treatment discontinuation 79 (1.1%) 88 (1.2%) -0.12 (-0.47, 0.23) 0.509

Source: Table 14.3.6.

Serious Adverse Events: There was no notable difference between the sitagliptin group and the placebo group with respect to the incidence of SAEs within any SOC or for any Preferred Term. Treatment Emergent Serious Adverse Events in at Least 1% of Patients in Either Group by System Organ Class – APaT

Sitagliptin Placebo N=7266 N=7274

Patients Events Patients Events n (%) n n (%) n

Neoplasms benign, malignant and unspecified (including cysts and polyps) 341 (4.7%) 405 371 (5.1%) 470

Injury, poisoning and procedural complications 146 (2.0%) 165 133 (1.8%) 153

Gastrointestinal disorders 130 (1.8%) 143 102 (1.4%) 121

Musculoskeletal and connective tissue disorders 118 (1.6%) 136 93 (1.3%) 102

Respiratory, thoracic and mediastinal disorders 66 (0.9%) 81 77 (1.1%) 95 Source: Table 14.3.26.

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CONCLUSIONS:  Sitagliptin, when used as part of usual diabetes care among patients with type 2 diabetes and preexisting CVD, is noninferior to usual diabetes care without sitagliptin with regard to the risk of developing confirmed MACE plus, a composite of CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.  Sitagliptin, when used as part of usual diabetes care among patients with type 2 diabetes and preexisting CVD, is noninferior to usual diabetes care without sitagliptin with regard to the risk of developing confirmed MACE, a composite of CV-related death, nonfatal MI or nonfatal stroke.  The addition of sitagliptin to usual diabetes care results in no notable difference in rates of any component of MACE plus or MACE.  The addition of sitagliptin to usual diabetes care compared to usual diabetes care without sitagliptin does not change rates of hospitalization for CHF, nor rates of the composite of hospitalization for CHF or CV death.  The addition of sitagliptin to usual diabetes care compared to usual diabetes care without sitagliptin does not change the long-term rates of death from any cause, CV death, or non-CV death; and does not impact the rates of specific causes of death, including infection.  Among patients treated with sitagliptin in addition to usual diabetes care compared to usual diabetes care without sitagliptin, over a median of three years of follow-up, no clinically relevant differences occur in the long-term incidence of diabetic complications, including diabetic eye disease, neuropathy, microalbuminuria, renal failure, peripheral vascular disease, gangrene, infections, GI conditions, and metabolic conditions.  No increase in the rate of severe hypoglycemia is seen among patients treated with sitagliptin plus usual diabetes care compared to usual diabetes care without sitagliptin.  Among patients treated with sitagliptin plus usual diabetes care, fewer require additional antihyperglycemic agents or the initiation of chronic insulin therapy compared with patients treated with usual diabetes care without sitagliptin.

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PUBLICATION(S): Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J 2013;166(6):983–989.

Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM, Holman RR and on behalf of the TECOS executive committee. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab 2015;17:395-402.

Green JB, Bethel MA, Armstrong MD, Buse JB, Engel SS, Garg J, et al. for the TECOS Study Group. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med; July16, 2015. 373(3):232-242.

Copies of these publications are provided in [16.1.11]. REPORT DATE: 28 September, 2015

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Bulk Product Description Manufacturing Lot Numbers

FCT MK-0431 100 mg, Beige (MMD) WL00044434, WL00047019, WL00047018, WL00043661, WL00049684, WL00049679, WL00051370, WL00051363, WL00050364, WL00053111, WL00053108, WL00055473, WL00055806, WL00030298, WL00030300, WL00032414, WL00035566, WL00035529, WL00037083, WL00037072, WL00038212, WL00038181, WL00040265, WL00040261, WL00040265, WL00042357, WL00042275, WL00042357, WL00044434, WL00044414 FCT MK-0431 100 mg Placebo, Beige WL00040654, WL00045919, WL00045898, (MMD) WL00036886, WL00048175, WL00048174, WL00050127, WL00050126, WL00050128, WL00050127, WL00052989, WL00052986, WL00054525, WL00052993, WL00014503, WL00033815, WL00033880, WL00033852, WL00036800, WL00036785, WL00036862, WL00036843, WL00038595, WL00038582, WL00040486, WL00038555, WL00040486, WL00040654, WL00040632 FCT Sitagliptin Phosphate 25 mg (MMD) WL00044634, WL00047321, WL00047320, WL00044634, WL00049115, WL00051362, WL00053102, WL00055501, WL00030935, WL00032241, WL00036380, WL00038196, WL00040351, WL00042260, WL00042258, WL00044634 FCT Sitagliptin Phosphate 25 mg Placebo WL00045249, WL00037248, WL00051627, WL00022836, WL00037248

048GX4 MK-0431-082 Protocol Amendments

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Principal Investigators

Site No: 001 Site No: 004 Basil Akpunonu, MD Anthony Bartkowiak Jr, MD Health Science Campus Station Medical Center 3000 Arlington Ave. Rm. 1192, 1414 9th Ave., Altoona, PA, 16602 Toledo, OH, 43614-2598 USA USA

Site No: 006 Site No: 007 Mark Feinglos, MD Vivian Fonseca, MD Baker House, 3rd Floor 1430 Tulane Ave. SL9 Trent Dr., Ste. 310-A New Orleans, LA, 70112 Box 3921, Durham, NC, 27710 USA USA

Site No: 008 Site No: 009 Richard Bergenstal, MD Venkatesh Nadar, MD 3800 Park Nicollet Blvd. 46 Red Hill Court Minneapolis, MN, 55416 Newport, PA, 17074 USA USA

Site No: 010 Site No: 011 Carolyn Pedley, MD Adrian Schnall, MD Downtown Health Plaza 1611 S Green Rd. # 065 1200 MLK Jr. Dr. Cleveland, OH, 44121 Winston-Salem, NC, 27101 USA USA

048GT0 3 Product: MK-0431 PAGE 1906 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 013 Site No: 015 Chhavi Chadha, MD Santosh Gill, MD 2220 Riverside Ave., 2088 Ogden Ave. Ste. 140 HealthPartners Riverside Research Aurora, IL, 60504 Research Dept., 3rd Floor, Minneapolis, MN, 55454 USA USA

Site No: 018 Site No: 019 Craig Vogel, MD John Buse, MD 500 University Blvd. Ste. 208 UNC Diabetes Care Center Jupiter, FL, 33458 5316 Highgate Dr. USA Ste. 125, Durham, NC, 27713 USA

Site No: 021 Site No: 023 Stephen Voyce, MD Patricia Wu, MD 475 Morgan Hwy 3955 Bonita Rd. P.O. Box 1103 Bldg. E, 2nd Floor Scranton, PA, 18508 Bonita, CA, 91902 USA USA

Site No: 025 Site No: 026 Kwame Osei, MD Kristen Hairston, MD Div. of Endocrinology, Diabetes and Metabolism Internal Medicine 491 McCampbell Hall Nutrition Bldg., East Floor 1581 Dodd Dr., Columbus, OH, 43210 Medical Center Blvd., Winston-Salem, NC, 27157 USA USA

048GT0 4 Product: MK-0431 PAGE 1907 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 028 Site No: 029 Judith White, MD Mark Chang, MD 105 W Stone Dr. 2428 Knob Creek Rd. 3rd Floor, Ste. 3A Johnson City, TN, 37604 Kingsport, TN, 37660 USA USA

Site No: 030 Site No: 031 Rex Force, MD Carol Wysham, MD Dept. of Family Medicine 310 N Riverpoint Blvd. 465 Memorial Dr. Spokane, WA, 99210-1495 ISU Campus Box 8357, Pocatello, ID, 83209 USA USA

Site No: 032 Site No: 034 Robert Zimmerman, MD Phillip Behn, MD 9500 Euclid Ave. F-20, 550 Landmark Ave. Cleveland, OH, 44195 Bloomington, IN, 47403 USA USA

Site No: 035 Site No: 039 Mary Ann Banerji, MD Ajit Raisinghani, MD 450 Clarkson Ave. 210 Dickinson St. Ste. A-112 MSC 123 San Diego, CA, 92103 Brooklyn, NY, 11203 USA USA

Site No: 040 Site No: 041 Masoud Azizad, MD Ajay Labroo, MD 18433 Roscoe Blvd. Ste. 210 2525 24th St Northridge, CA, 91325 Rock Island, IL, 61201 USA USA

048GT0 5 Product: MK-0431 PAGE 1908 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 042 Site No: 044 David Goff, MD Laurie Sadler, MD Dept. of Epi and Prevention 2322 East 22nd St. Ste. 310 Medical Center Blvd. Cleveland, OH, 44115 , Winston Salem, NC, 27517 USA USA

Site No: 045 Site No: 046 Waymon Drummond, MD Pamela Dugano-Daphnis, MD 5959 Harry Hines Blvd. Ste. 820 333 N Texas Ave. Ste. 4100 Dallas, TX, 75235 Webster, TX, 77598 USA USA

Site No: 048 Site No: 050 Howard Weintraub, MD George Anagnostis, MD 530 First Ave. 1300 S Fielder Rd. Ste. Schwartz 4F Arlington, TX, 76013 New York, NY, 10016 USA USA

Site No: 051 Site No: 052 Negah Rassouli, MD Mark Davies, MD Cumberland Medical Office 6550 Fannin St 2525 Cumberland Pkwy. Houston, TX, 77030 Atlanta, GA, 30339 USA USA

048GT0 6 Product: MK-0431 PAGE 1909 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 053 Site No: 054 Jeanine Albu, MD Drake DeHart, MD Barcock Bldg., Rm. 1022 3 Dairyland Square Shopping Center 1111 Amsterdam Ave. Red Lion, PA, 17356 New York, NY, 10025 USA USA

Site No: 057 Site No: 058 Alan Forker, MD Priya Dayamani, MD 4320 Wornall Rd. 1365 Clifton Rd., NE MP1, Ste. 128 Ste. A2205 Kansas City, MO, 64111 Atlanta, GA, 30322 USA USA

Site No: 059 Site No: 062 Naynesh Patel, MD Mario De Meireles, MD 513 E Stroop Rd. 23874 Kean St. Kettering, OH, 45429 Dearborn Heights, MI, 48124 USA USA

Site No: 063 Site No: 064 Chris Sorli, MD Anuj Bhargava, MD 1045 North 30th St. 411 Laurel St. Ste. 3262 Billings, MT, 59101 Des Moines, IA, 50314 USA USA

Site No: 065 Site No: 066 Tim Garvey, MD Aaron Vinik, MD Dept. of Nutrition Sciences, Webb 232 855 W Brambleton Ave. 1675 University Blvd. Norfolk, VA, 23510 Birmingham, AL, 35294-3360 USA USA

048GT0 7 Product: MK-0431 PAGE 1910 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 067 Site No: 068 Robert Busch, MD Charles Eaton, MD 1365 Washington Ave. Clinical Studies Center Ste. 300, Albany, NY, 12206 111 Brewster St. USA Pawtucket, RI, 02860 USA

Site No: 069 Site No: 070 Ronald Sigal, MD Lawrence Leiter, MD 1820 Richmond Rd., SW 61 Queen St., E Calgary, AB, T2T 5C7 Canada Rm. 6-121 Toronto, ON, M5C 2T2 Canada

Site No: 071 Site No: 072 Yves Robitaille, MD Remi Rabasa-Lhoret, MD Recherche en Cardiologie 110 Ave. des Pins Ouest 911 Montee des Pionniers Montreal, QC, H2W 1R7 Canada Terrebonne, QC, J6V 2H2 Canada

Site No: 074 Site No: 075 Richard Dumas, MD David Miller, MD 3030 boulevard le Carrefour 3939 Quadra St. #305-A, Laval, QC, H7T 2P5 Canada Ste. 402, Victoria, BC, V8Z 7G4 Canada

Site No: 076 Site No: 077 John Sigalas, MD Jan Kornder, MD 2863 Ellesmere Rd. 13798-94A Ave. Scarborough, ON, M1E 5E9 Canada Ste. 203, Surrey, BC, V3V 1N1 Canada

048GT0 8 Product: MK-0431 PAGE 1911 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 079 Site No: 080 Claude Garceau, MD Jean-Louis Chiasson, MD 2725 Chemin Sainte-Foy CRCHUM - Tour Viger Pavillon U local U-4755 900 St-Denis Rm 07.426, Montreal, QC, H2X 0A9 Canada Quebec, QC, G1V 4G5 Canada

Site No: 081 Site No: 082 Vincent Woo, MD Bernard Zinman, MD Health Sciences Centre 60 Murray St. 838-715 McDermot Ave. Rm. 5014, Toronto, ON, M5T 3L9 Canada Winnipeg, MB, R3E 3P4 Canada

Site No: 083 Site No: 084 Stephanie Kaiser, MD Irene Hramiak, MD Endocrinology and Metabolism 268 Grosvenor St. 7N Victoria Bldg., Rm. 48 London, ON, N6A 4V2 Canada 1276 S Park St., Halifax, NS, B3H 2Y9 Canada

Site No: 091 Site No: 098 Zubin Punthakee, MD Ehud Ur, MD 1200 Main St., W 2775 Laurel St. Hamilton, ON, L8N 3Z5 Canada Ste. 4113 Vancouver, BC, V5Z 1M9 Canada

Site No: 099 Site No: 100 Jean-Francois Yale, MD William Kaye, MD McGill University Health Centre 1515 N Flagler Dr. 687 Pine Ave.,W Ste. 440 Rm.H6.85, Montreal, QC, H3A 1A1 Canada West Palm Beach, FL, 33401 USA

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Principal Investigators

Site No: 101 Site No: 102 Vanita Aroda, MD Stephen Nash, MD 6525 Belcrest Rd. 600 E Genessee St. Hyattsville, MD, 20782 Ste. 204 USA , Syracuse, NY, 13202 USA

Site No: 106 Site No: 107 Thomas Repas, MD Roy Harris, MD 2929 5th St. 510 Hill St. Ste. 220 Bucyrus, OH, 44280 , Rapid City, SD, 57701 USA USA

Site No: 108 Site No: 110 Daniel Donovan, MD Asqual Getaneh, MD 161 Fort Washington Ave. 622 W 168th St. Ste. 212, New York, NY, 10032 Irving Institute - Outpatient USA PH 10, Rm. 307, New York, NY, 10032 USA

Site No: 111 Site No: 112 Ulrich Schubart, MD Behjath Jafry, MD Bldg. # 5 University Medical Center 1400 Pelham Pkwy., S Three Cooper Plaza Bronx, NY, 10461 Camden, NJ, 08103 USA USA

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Principal Investigators

Site No: 113 Site No: 171 Hal Roseman, MD Viswanathan Mohan, MD 2400 Patterson St ICMR Advanced Centre for Genomics of Diabetes Ste. 119, Nashville, TN, 37203 Conran Smith Rd., No. 6B USA Gopalapuram, Chennai, Tamil Nadu, 600086 India

Site No: 172 Site No: 173 Vijayam Balaji, MD Minakshisundharam Shunmugavelu, MD # 729, P.H. Rd. Trichy Diabetes Speciality Centre, Centre for Comprehensive Care and Research Aminjikarai, Chennai, Tamil Nadu, 600029 India B37, Shasthri Rd., 7th Cross East

Thillai Nagar, Trichy, Tamil Nadu, 620018 India

Site No: 175 Site No: 176 Johann Christopher, MD Jothydev Kesavadev, MD Exhibition Ground Rd. JDC Junction, Mudavanmugal Nampally, Hyderabad, Telangana, 500001 India Trivandrum, Kerala, 695032 India

Site No: 177 Site No: 180 Ambrish Mithal, MD Sanjay Kalra, MD Sarita Vihar Bharti Hospital Delhi Mathura Rd. Wazir Chand Colony New Delhi, New Delhi, 110076 India Kunjpura Rd., Karnal, Hrayana, 132001 India

Site No: 181 Site No: 182 Harshada Kudalkar, MD Pankaj Agarwal, MD Sardar Moodliar Road S-B-5, Shastri Nagar Rastha Peth, Pune, Maharashtra, 411011 India Near Saint Mary School, Ghaziabad, Uttar Pradesh, 201002 India

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Principal Investigators

Site No: 185 Site No: 187 Ajay Kumar, MD Sanjiv Shah, MD G.C. - 1B, Near Overbridge Kamalvan Society, 1st Floor, Office no. 4 Kankarbagh, Patna, Bihar, 800020 India M. G. Road, Link Road Junction Dahanukar Wadi, Kandivli West, Mumbai, Maharashtra, 400067 India

Site No: 188 Site No: 189 Shailesh Pitale, MD Sunil Ambulkar, MD Shriman Complex, Ground Floor 79 Bajaj Nagar Near Lokmat Sq., Dhantoli Nagpur, Maharashtra, 440010 India Nagpur, Maharashtra, 440012 India

Site No: 235 Site No: 236 Jocelyne Benatar, MD Russell Scott, MD Level 14, Rm. 142.002 Christchurch Hospital Campus Park Rd., Grafton The Diabetes Research Institute, 2nd Floor Private Bag 92 189, Auckland, Auckland, 1030 New 40 Stewart St., Christchurch, , 8140 New Zealand Zealand

Site No: 237 Site No: 238 Patrick Manning, MD Robert Leikis, MD Endocrinology and Nephrology Research Cardiology Dept. 9th Floor Omahu Rd. 201 Great King St., Dunedin, Otago, 9016 New Hastings, Hawke's Bay, 4120 New Zealand Zealand

Site No: 239 Site No: 240 John Baker, MD Richard Cutfield, MD Support Bldg., Ground Floor Diabetes Service Hospital Rd. Private Bag 93503 Otahuhu, Auckland, , 1640 New Zealand Takapuna, Auckland, Auckland, 0622 New Zealand

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Principal Investigators

Site No: 241 Site No: 242 Mike Williams, MD Jeremy Krebs, MD 1203 Haupapa St. Level 5, Greace Neill Block Rotorua, Akaroa County, 3010 New Zealand Riddiford St. Newtown, Wellington, 6021 New Zealand

Site No: 243 Site No: 275 David Robbins, MD Andre Carpentier, MD 5901 Rainbow Blvd. Hopital Fleurimont Kansas City, KS, 66160 3001 12 e Ave. Nord. USA Sherbrooke, QC, J1H 5N4 Canada

Site No: 282 Site No: 283 Christian Constance, MD Laurie Mereu, MD 5700, St-Zotique 362 Heritage Medical Research Centre Ste. 206 Edmonton, AB, T6G 2S2 Canada Montreal, QC, H1T 3Y7 Canada

Site No: 284 Site No: 285 Steve Stranks, MD Parind Vora, MD Southern Adelaide Diabetes and Endocrine Service Clinical Trials Unit Daws Rd. Haydown Rd. Daw Park, South Australia, 5041 Australia Level 2, DIvision of Medicine, Adelaide, South Australia, 5112 Australia

Site No: 286 Site No: 287 Wah Cheung, MD Robert Moses, MD Dept. of Diabetes and Endocrinology - ICTMR Clinical Trial and Research Unit Level 2, Rm. 2078 Level 2 Center Hawksbury and Darcy Rd., Westmead, New 304 Crown St., Wollongong, New South Wales, 2500 South Wales, 2145 Australia Australia

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Principal Investigators

Site No: 288 Site No: 291 Greg Fulcher, MD Joe Proietto, MD Sydney Diabetes Research Unit Dept. of Medicine Baronia Bldg. Main Bldg., Level 3 Bldg. 24 St. Leonards, New South Wales, 2065 Australia 300 Waterdale Rd., Heidleberg Heights, Victoria, 3081 Australia

Site No: 292 Site No: 293 Richard Simpson, MD Jonathan Shaw, MD Box Hill Specialist Consult Rm. The Alfred Centre, Level 4 50 Nelson Rd. 99 Commercial Rd. Ste. 33, Box Hill, Victoria, 3128 Australia Melbourne, Victoria, 3004 Australia

Site No: 295 Site No: 296 Ashim Sinha, MD Murray Gerstman, MD 381 Sheridan St. 7 Ware Crescent North Cairns, Queensland, 4870 Australia Ringwood East, Victoria, 3135 Australia

Site No: 297 Site No: 298 Adam Roberts, MD Peter Colman, MD Dept. of Clinical and Biomedical Science Grattan St. Corner of Bellerine and Myers St. Parkville, Victoria, 3050 Australia Geelong, Victoria, 3320 Australia

Site No: 299 Site No: 300 Duncan Topliss, MD Ferdinandus De Looze, MD Dept. of Endocrinology and Diabetes Level 1, Ste. 5 Commercial Rd. 14 Primrose St. Melbourne, Victoria, 3004 Australia Sherwood, Queensland, 4075 Australia

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Principal Investigators

Site No: 301 Site No: 302 Patrick Carroll, MD Yong Tan, MD Research/Ethics Hub 36 Fulham Rd. Unit 1 Ground Level Pimlico, Queensland, 4812 Australia Anzac Ave., Redcliffe, Redcliffe, Queensland, 4020 Australia

Site No: 303 Site No: 304 Ferdinandus De Looze, MD Tim Davis, MD 21-25 Bertha St. School of Medicine and Pharmacology Caboolture, Queensland, 4510 Australia Level 7, T Block Alma St., Fremantle, Western Australia, 6160 Australia

Site No: 407 Site No: 412 Michael Dulin, MD Shamanna Srikanta, MD Dept. of Family Medicine J.P. Nagar, Phase II Mercy Medical Plaza # 2, 1A Cross, Marenahalli 2001 Vail Ave., Ste. 400, Charlotte, NC, 28207 Bangalore, Karnataka, 560078 India USA

Site No: 413 Site No: 415 Sosale Aravind, MD Naveen Reddy, MD 1st Block, Rajaji Nagar 5-9-22 Secretariat Rd. B-59/360, 19th Main Hyderabad, Andhra Pradesh, 500063 India , Bangalore, Karnataka, 560010 India

Site No: 466 Site No: 471 Bernard Erickson, MD Suzanne Oparil, MD 1406 6th Ave., N 933 19th St. South Rm. 115 St. Cloud, MN, 56303 Birmingham, AL, 35294 USA USA

048GT0 15 Product: MK-0431 PAGE 1918 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 479 Site No: 481 Patricia Kapsner, MD Helen Lunt, MD 2211 Lomas Blvd., NE 550 Hagley Ave ACC 5 Christchurch, , 8011 New Zealand Albuquerque, NM, 87131-0001 USA

Site No: 482 Site No: 484 Philomena Ukwade, MD Stephen Lewis, MD 401 E. Parkwood Ave. Cardiac Research Dept. Friendswood, TX, 77546 10498 Montgomery Rd. USA Ste. A, Cincinnati, OH, 45242 USA

Site No: 491 Site No: 500 Ferdinandus De Looze, MD Thao Huynh, MD 21-25 Bertha St. Cardiology Dept. Caboolture, Queensland, 4510 Australia 1650 Cedar Ave. Rm. L.E5-200, Montreal, QC, H3G 1A4 Canada

Site No: 501 Site No: 502 Stanley Weisnagel, MD Kibar Yared, MD 2705 boul. Laurier 3030 Lawrence Ave. E. Rm. TR-27 Ste. 301 , Quebec, QC, G1V 4G2 Canada Scarborough, ON, M1P 2T7 Canada

Site No: 507 Site No: 508 Saul Vizel, MD Anne Goldberg, MD 715 Coronation Blvd. 660 S Euclid Ave. Ste. 1, Cambridge, ON, N1R 7R1 Canada Campus Box 8127 St. Louis, MO, 63110 USA

048GT0 16 Product: MK-0431 PAGE 1919 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 509 Site No: 512 William Cushman, MD Marty Turner, MD Hypertension and Lipids Research, Section (111Q) 7829 E Rockhill St. 1030 Jefferson Ave. Ste. 301, Wichita, KS, 67206 Memphis, TN, 38104 USA USA

Site No: 518 Site No: 519 Michael Lillestol, MD Ambrish Mithal, MD 1711 Gold Dr., S Sector - 38 Ste. 170, Fargo, ND, 58103 Gurgaon, Haryana, 122001 India USA

Site No: 520 Site No: 521 Philip Levy, MD Tara Seneviratne, MD 1300 North 12th St. 2425 East St. Ste.15 Ste. 600, Phoenix, AZ, 85006 Concord, CA, 94520 USA USA

Site No: 522 Site No: 526 Linda Gaudiani, MD Rochelle Elijah, MD 900 S Eliseo Dr. Ste. 201 41 Montebello Rd. Ste. 201 Greenbrae, CA, 94904 Pueblo, CO, 81001 USA USA

Site No: 527 Site No: 528 Alan Cohen, MD Mary Ellen Sweeney, MD 5659 S Rex Rd. 1670 Clairmont Rd. Memphis, TN, 38119 151-CSC, 11C 105 USA Decatur, GA, 30033 USA

048GT0 17 Product: MK-0431 PAGE 1920 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 529 Site No: 532 Debra Simmons, MD Vasilios Papademetriou, MD 4300 West 7th St. 50 Irving St., NW Rm. 151-E 111J/LR Rm. 4E 128, Little Rock, AR, 72205 Washington, DC, 20422 USA USA

Site No: 533 Site No: 535 David Klonoff, MD Ashok Sharma, MD 100 S San Mateo Dr. Okhla Rd. Rm. 5145, San Mateo, CA, 94401 New Delhi, Delhi, 110025 India USA

Site No: 543 Site No: 545 Gulla Suryaprakash, MD Anoop Misra, MD Market St. Near Clock Tower Aruna Asaf Ali Marg, Vasant Kunj Secunderabad, Andhra Pradesh, 500003 India Sector B, Pocket 1 New Delhi, Delhi, 110070 India

Site No: 547 Site No: 568 Fredrick Dunn, MD Michael Harris, MD 4500 S Lancaster Rd. 1215 S 1680 W Dallas, TX, 75216 Orem, UT, 84058 USA USA

Site No: 571 Site No: 572 Kenneth O'Neal, MD Paramesh Shamanna, MD 31 Hilltop Dr. No. 416 Ste. 33, Jefferson, GA, 30549 4th Cross, 2nd Block USA Kalyan Nagar, Bangalore, Karnataka, 560043 India

048GT0 18 Product: MK-0431 PAGE 1921 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 573 Site No: 574 Kevin Adkins, MD Vonda Houchin, MD 614 North Town St. 802 Illinois St. Mountain Home, AR, 72653 Harrisburg, AR, 72432 USA USA

Site No: 575 Site No: 576 Mark Wood, MD Joshua Cohen, MD 300 Carson St. 2150 Pennsylvania Ave., NW Jonesboro, AR, 72401 Washington, DC, 20037 USA USA

Site No: 578 Site No: 579 John Gabriel, MD Lawrence Levinson, MD 4351 Booth Calloway Ste. 401 4371 E Pleasant Valley Blvd. North Richland Hills, TX, 76180 Tipton, PA, 16684 USA USA

Site No: 581 Site No: 582 Roger Estevez, MD Anthony Vo, MD 2755 E Desert Inn Rd. 5901 E 7th St. Ste. 275 09/151-M230 Las Vegas, NV, 89121 Long Beach, CA, 90822 USA USA

Site No: 583 Site No: 586 Michael Shanik, MD Georges Argoud, MD 732 Smithtown Bypass Ste. 103 340 Fourth Ave. Suite 7A Smithtown, NY, 11787 Chula Vista, CA, 91910 USA USA

048GT0 19 Product: MK-0431 PAGE 1922 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 591 Site No: 592 Louis Luttrell, MD Lawrence Anastasi, MD 109 Bee St. 9501 Ventnor Ave. Charleston, SC, 29401 Margate, NJ, 08402 USA USA

Site No: 593 Site No: 594 John Tsao, MD Patricia Buchanan, MD 3445 Pacific Coast Hwy. Ste. 100 890 River Rd. Torrance, CA, 90505 Eugene, OR, 97404 USA USA

Site No: 596 Site No: 598 Marc Rendell, MD Michael dEmden, MD 601 North 30th St. Ste. 6715 Endocrinology Research Unit Omaha, NE, 68131 Level 1, East Block USA Butterfield St., Herston, Queensland, 4029 Australia

Site No: 599 Site No: 600 Jonathon Waites, MD Maurits Binnekamp, MD Cardiology Dept. Cardiology Clinical Trials 246 Pacific Hwy. Cardiology Dept., Clinical Services Bldg., Level 1 Coffs Harbour, New South Wales, 2450 Australia Gray St., Kogarah, New South Wales, 2217 Australia

Site No: 614 Site No: 616 Alexander Higgins, MD Adrienne Prentiss, MD 318 White Horse Pike 1704 Tennison Pkwy. Haddon Heights, NJ, 08035 Ste. 100, Colleyville, TX, 76034 USA USA

048GT0 20 Product: MK-0431 PAGE 1923 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 618 Site No: 619 Robert Detweiler, MD Helena Rodbard, MD 1970 N Broad St. 3200 Tower Oaks Blvd. Lansdale, PA, 19446 Ste. 250, Rockville, MD, 20852 USA USA

Site No: 620 Site No: 621 Horacio Hidalgo Jr, MD Mark Radbill, MD 833 Durham Rd. 2426 Bristol Rd. Penndel, PA, 19047 Bensalem, PA, 19020 USA USA

Site No: 625 Site No: 626 Peter Rees, MD Bertrand Cole, MD 421 Merrimack St. 2299 Woodberry Ave. Ste. 203, Methuen, MA, 01844 Newington, NH, 03801 USA USA

Site No: 627 Site No: 628 Cynthia Cheng, MD Lisa Connery, MD 1015 Walnut St. Ste. 401, 1010 24th Ave., NW Philadelphia, PA, 19107 # 110, Norman, OK, 73069 USA USA

Site No: 629 Site No: 630 Ivy Madu, MD Rajneesh Reddy, MD 1234 W Chapman Ave. Ste. 205, 2919 Markum Dr. Orange, CA, 92868 Fort Worth, TX, 76117 USA USA

048GT0 21 Product: MK-0431 PAGE 1924 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 636 Site No: 637 Naseem Jaffrani, MD Steven Nagelberg, MD 501 Medical Center Dr. 9501 Roosevelt Blvd. Ste. 250 Philadelphia, PA, 19114 Alexandria, LA, 71301 USA USA

Site No: 638 Site No: 639 Bryan Merrick, MD Michael Cooperman, MD 205 Hospital Dr. 921 W Cheltenham Ave. Ste. A Melrose Park, PA, 19027 McKenzie, TN, 38201 USA USA

Site No: 640 Site No: 667 Steven Goldman, MD Donald Bias, MD Dept. of Cardiology (1-111C) 1470 E Gaston St. 3601 South 6th Ave. Ste. 300 Tucson, AZ, 85723 Lincolnton, NC, 28092 USA USA

Site No: 669 Site No: 670 Robert McNeill, MD Donald Fox, MD 410 Mocksville Ave. 2801 Island Ave. Ste. 10 Salisbury, NC, 28144 Philadelphia, PA, 19153 USA USA

Site No: 768 Site No: 769 Glenn Jacobs, MD W. Herbert Haught, MD 368 Lakehurst Rd. 105 Rands Ave. Ste. 301, Toms River, NJ, 08755 Huntsville, AL, 35801 USA USA

048GT0 22 Product: MK-0431 PAGE 1925 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 773 Site No: 777 Muthu Ramu, MD Shekhar Pandey, MD Kalidasan St., # 2 150 Hespeler Rd. Tambaram East Cambridge, ON, N1R 6V6 Canada Chennai, Tamil Nadu, 600059 India

Site No: 793 Site No: 800 Pierre Filteau, MD Sam Lehman, MD 1000 Boul. Dussault 50 Marleston Ave. Saint Marc-des-Carrieres, QC, G0A 4B0 Canada Ashford, South Australia, 5035 Australia

Site No: 801 Site No: 805 A. Sharda, MD Andrew Hamilton, MD No.640, 1st Main, 1st Stage 240 Glen Osmond Rd. Indiranagar, Bangalore, Karnataka, 560038 India , Fullarton, South Australia, 5063 Australia

Site No: 849 Site No: 850 Gordon Hoag, MD Kevin Saunders, MD 601 A Discovery St. 2605 Main St. Victoria, BC, V8T 5G4 Canada Unit 2, Winnipeg, MB, R2V 4W3 Canada

Site No: 851 Site No: 880 David Grunbaum, MD Harold Bays, MD 1515 Notre Dame 3288 Illinois Ave. Lachine, QC, H8S 2E4 Canada Louisville, KY, 40213 USA

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Principal Investigators

Site No: 881 Site No: 883 Eric Bolster, MD Ronald DAgostino, MD 201 Oakbrook Lane Ste. 255, 1129 Northern Blvd #408, Summerville, SC, 29485 Manhasset, NY, 11030 USA USA

Site No: 884 Site No: 885 Julius Dean, MD Rodney Ison, MD 4205 Belfort Rd. Ste. 2067 944 E Cherry St. Jacksonville, FL, 32216 Canal Fulton, OH, 44614 USA USA

Site No: 889 Site No: 891 Richard Lorraine, MD Derek Muse, MD 176 Main St. 4460 S Highland Dr. Ste. 410 Harleysville, PA, 19438 Salt Lake City, UT, 84124 USA USA

Site No: 894 Site No: 895 Lance Rudolph, MD John Sensenbrenner, MD 300 Oak St., NE 8821 Blakeney Professional Dr. , Albuquerque, NM, 87106-4725 Charlotte, NC, 28277 USA USA

Site No: 896 Site No: 899 Jeffrey Shanes, MD Irving Loh, MD 675 W North Ave. Ste. 210 550 St. Charles Dr. Ste. 208, Melrose Park, IL, 60160 Thousand Oaks, CA, 91360 USA USA

048GT0 24 Product: MK-0431 PAGE 1927 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 900 Site No: 901 Jane Rohlf, MD Anil Shah, MD 708 Chambers St. 2621 S Bristol St. Ste. 108 Trenton, NJ, 08611 Santa Ana, CA, 92704 USA USA

Site No: 903 Site No: 904 Alberto Odio, MD Mark Gelernt, MD 2925 N Sycamore Dr. 525 State St. Ste. 3 Suite 204 Elmer, NJ, 08318 , Simi Valley, CA, 93065 USA USA

Site No: 908 Site No: 911 Frank Metzger, MD Mark Stich, MD 335 N Alma School Rd. Ste. D 810 Lane Ave., S Ste. 1 Chandler, AZ, 85224 Jacksonville, FL, 32205 USA USA

Site No: 913 Site No: 934 Rashmi Schramm, MD Harvey Snyder, MD 141 Hilden Rd. Ste. 201 210 W Atlantic Ave. Ponte Vedra, FL, 32081 Haddon Heights, NJ, 08035 USA USA

Site No: 935 Site No: 937 Dilip Viswanath, MD Ronald Garcia, MD 570 Egg Harbor Rd. Ste. B-1 2829 Babcock Rd. Ste. 540 Sewell, NJ, 08080 San Antonio, TX, 78229 USA USA

048GT0 25 Product: MK-0431 PAGE 1928 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 046A Site No: 115 Pamela Dugano-Daphnis, MD Marijona Sulskiene, MD 1650 B East Winding Way Blvd. Liepojos 41 Friendswood, TX, 77546 Klaipeda LT-92288 USA Lithuania

Site No: 116 Site No: 117 Dzilda Velickiene, MD Ausra Sirutaviciene, MD Savanoriu pr. 369 V. Kudirkos 99 Kaunas LT-49427 Siauliai LT-76231 Lithuania Lithuania

Site No: 118 Site No: 119 Andrej Levinger, MD Liuda Urbanaviciene, MD Taikos pr. 103 Zirmunu 67a Klaipeda LT-94198 Vilnius LT-09112 Lithuania Lithuania

Site No: 120 Site No: 121 Neli Jakuboniene, MD Isabella Tritto, MD Savanoriu 423 P.zza Meneghini, S.Andrea delle Fratte Kaunas LT-49287 Perugia 6156 Lithuania Italy

Site No: 122 Site No: 123 Lucia Del Vecchio, MD Sergio Gambardella, MD Via dell´Eremo9/11 Via Duilio Cambellotti, 11 Lecco 23900 Rome 133 Italy Italy

048GT0 26 Product: MK-0431 PAGE 1929 28 SEPTEMBER 2015 Clinical Study Report PN-082

Principal Investigators

Site No: 124 Site No: 126 Piermarco Piatti, MD Anna Frisinghelli, MD via Olgettina, 48/60 Via Settembrini, 1 Milano 20132 Passirana di Rho 20017 Italy Italy

Site No: 127 Site No: 128 Sergio Mondillo, MD Roberto Pedrinelli, MD Viale Bracci via Paradisa,2 Siena 53100 Pisa 56124 Italy Italy

Site No: 129 Site No: 130 Franco Cavalot, MD Boris Krahulec, MD Regione Gonzole, 10 Holubyho 41 Orbassano Torino10043 Pezinok 90201 Italy Slovakia

Site No: 131 Site No: 134 Jana Zimanova, MD Jaroslav Fabry, MD Racianska 76 Drienova 38 Bratislava 83604 Bratislava 82102 Slovakia Slovakia

Site No: 135 Site No: 136 Ingrid Buganova, MD Eva Toserova, MD V. Spanyola 8187 Svabinskeho 15 Zilina 01001 Bratislava 85101 Slovakia Slovakia

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Principal Investigators

Site No: 138 Site No: 139 Mihály Dudás, MD Karoly Nagy, MD Semmelweis u. 1 . Bécsi út 61. Gyula H-5700 Budapest H-1036 Hungary Hungary

Site No: 140 Site No: 141 Irén Földesi, MD Tibor Fülöp, MD Sima Ferenc u. 44-58. Móricz Zs. u. 22. Szentes H-6600 Debrecen H-4032 Hungary Hungary

Site No: 142 Site No: 143 Tamás Oroszlán, MD Zsolt Pécsvárady, MD Zrínyi u. 1. Semmelweis tér 1. Zalaegerszeg H-8900 Kistarcsa H-2143 Hungary Hungary

Site No: 144 Site No: 154 Peter Ofner, MD Gwendolyn Bender, MD Haller u. 29. Oberdürrbacher Str. 6 - Haus A3 Budapest H-1096 Würzburg 97080 Hungary Germany

Site No: 155 Site No: 158 Klaus Badenhoop, MD Andreas Hamann, MD Theodor-Stern-Kai 7 Küchlerstrasse 2 Frankfurt am Main 60590 Bad Nauheim 61231 Germany Germany

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Principal Investigators

Site No: 159 Site No: 160 Markolf Hanefeld, MD Christian Kasperk, MD Blasewitzer Str. 43 Im Nauenheimer Feld 410 Dresden 1307 Heidelberg 69120 Germany Germany

Site No: 161 Site No: 162 Erika-Maria Oerter, MD Petra Ott, MD Eichendorffstraße 12 D Rabenauer Strasse 9 Würzburg 97072 Dippoldiswalde 1744 Germany Germany

Site No: 163 Site No: 164 Björn Paschen, MD Axel Riefflin, MD Am Wall 1 Kirchstrasse 2 Hamburg 21073 Husby 24975 Germany Germany

Site No: 165 Site No: 166 Petra-Maria Schumm-Draeger, MD Thomas Segiet, MD Englschalkinger Straße 77 Hilgardstr. 30 Ärztehaus 2 München 81925 Speyer 67346 Germany Germany

Site No: 167 Site No: 168 Andrea Tytko, MD Hermann-Josef Strotmann, MD Auf dem Schafsberg Über dem Gericht 26 Limburg an der Lahn 65549 Rotenburg 36199 Germany Germany

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Principal Investigators

Site No: 169 Site No: 191 Ulrich Wendisch, MD Mariana Georgieva, MD Beselerstraße 2A 29, Hristo Botev str. Hamburg 22607 Dimitrovgrad 6400 Germany Bulgaria

Site No: 192 Site No: 193 Antoanela Slavcheva, MD Tsvetalina Tankova, MD 2 Nezavisimost Str. 2 Zdrave St. Ruse 7002 Sofia 1431 Bulgaria Bulgaria

Site No: 194 Site No: 195 Ivan Cinlikov, MD Liudmila Liubenova, MD 91 '' Vladimir Vazov'' St. 38“Makedonia” Blv. Pleven 5800 Sofia 1606 Bulgaria Bulgaria

Site No: 196 Site No: 197 Damyanova Velichka, MD Larry Distiller, MD Ovcha Kupel 2 Square 18 Centre of Diabetes and Endocrynology 81 Central Street Sofia 1632 Johannesburg 2000 Bulgaria South Africa

Site No: 198 Site No: 199 Graham Ellis, MD Paul Rheeder, MD 7G&H Arun Place Sir Lowry's Pass Road Room 2-54, Pathology Building Prinshof Medical Campus Somerset Western 7130 Pretoria 83 South Africa South Africa

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Principal Investigators

Site No: 200 Site No: 201 Naeem Siddique, MD Andie Van Der Merwe, MD Synapta Clinical Research Centre Suite 704, 7th Langeberg Medical Centre C/O Brighton & Kipling Floor Roads Durban 4001 Kraaifontein 7570 South Africa South Africa

Site No: 202 Site No: 203 Louie Van Zyl, MD Alexander Sherenkov, MD Clinical Projects Research SA (Pty) Ltd 42 Russell 15, Novocherkasskiy prospekt, 195112,St.Petersburg, Street Russia Worcester 6850 St.Petersburg 195112 South Africa Russian Federation

Site No: 205 Site No: 206 Natalia Shilkina, MD Vladimir Zadionchenko, MD Suzdalskoe shosse 39 6, Dvintsev str. Yaroslavl 150030 Moscow 127015/127018 Russian Federation Russian Federation

Site No: 207 Site No: 208 Alina Babenko, MD Mikhail Kotelnikov, MD 2, Akkuratova ul. 4, Novaya Ipatovka ul. St. Petersburg 197341 Moscow 127299 Russian Federation Russian Federation

Site No: 0 Site No: 211 Stanislav Pekarskiy, MD Alexander Demin, MD 23, Moskovskiy trakt 41,Ykusheva str Tomsk 634050 Novosibirsk 630008 Russian Federation Russian Federation

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Principal Investigators

Site No: 214 Site No: 216 Olga Barbarash, MD Alexander Dreval, MD Sosnovy Bulvar,6 61/2 Shchepkina ul. Kemerovo 650002 Moscow 129110 Russian Federation Russian Federation

Site No: 217 Site No: 219 Nikolay Gratsiansky, MD Sigita Pastare, MD 2, Gospitalnaya ploshchad Zemgales prosp. 15 Moscow 111020 Jelgava LV 3001 Russian Federation Latvia

Site No: 220 Site No: 221 Natalja Kakurina, MD Ruta Eglite, MD Vasarnicu street 20 Smilsu street 22 Daugavpils LV 5417 Kuldiga LV 3300 Latvia Latvia

Site No: 222 Site No: 223 Valdis Pirags, MD Astra Balode, MD Pilsonu street 13 Patversmes 23 Riga LV 1002 Riga LV 1005 Latvia Latvia

Site No: 224 Site No: 225 Andrzej Tykarski, MD Lukasz Koltowski, MD ul. Dluga 1/2 ul. Szpacza 2 Poznan 61-848 Warszawa 04-238 Poland Poland

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Principal Investigators

Site No: 226 Site No: 227 Katarzyna Cypryk, MD Edyta Artemiuk, MD ul. Rzgowska 281/289 Jaskowa Dolina 105 Lódz 93-338 Gdansk 80-288 Poland Poland

Site No: 230 Site No: 232 Iwona Jakubowska, MD Jolanta Kitowska-Koterla, MD ul. M. Sklodowskiej-Curie 26 ul. Opolska 11/3 Bialystok 15-950 Katowice 40-084 Poland Poland

Site No: 233 Site No: 245 Agnieszka Karczmarczyk, MD Adela Rovira, MD ul. Boguchwaly 2d/10 (office) ul. Nieduza 2 (activity Avda. Reyes Católicos 2 place) Madrid 28040 Szczecin 71-531 Spain Poland

Site No: 246 Site No: 247 Luis de Teresa, MD Alberto Martin-Hidalgo, MD C/ Poeta Quintana 56 Camí de L´Amazara,11 Servicio de Medicina Interna Alicante 03004 Elche 3203 Spain Spain

Site No: 248 Site No: 249 Salvador Tranche, MD Andreu Nubiola, MD Alvaro Florez Estrada, 21 Avda. Mossén Pons i Rabadà, s/n Oviedo 33006 Santa Coloma de Gramanet 8923 Spain Spain

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Principal Investigators

Site No: 250 Site No: 251 Cristóbal Morales, MD Florence TRAVERT, MD Servicio de Endocrinología y Nutrición Edificio Service de diabétologie 46 rue Henri HUCHARD Policlínico, Planta 2ª Paris 75018 Sevilla 41009 France Spain

Site No: 252 Site No: 253 Annie Clergeot, MD Jean-Pierre COURREGES, MD HOPITAL J MINJOZ Service d'Endocrinologie Service de Diabétologie Boulevard Lacroix Métabolisme et Diabétologie Nutrition Narbonne 11100 BESANCON Cedex 25030 France France

Site No: 254 Site No: 255 Philippe MOULIN, MD J.H. Cornel, MD U11-Fédération d’Endocrinologie Diabète-Nutrition Wilhelminalaan 12 Cardiologie 117 28 avenue du Doyen Lépine Alkmaar 1815 JD BRON 69677 Netherlands France

Site No: 256 Site No: 258 Wouter van Kempen, MD Jan Skrha, MD Mathenesserlaan 247 U Nemocnice 1 Rotterdam 3021 HC Prague 2 12000 Netherlands Czech Republic

Site No: 261 Site No: 262 Katerina Hejnicova, MD Martin Petr, MD Na Struze 30 Hostinskeho 1533/4 Trutnov 54101 Prague 5 15500 Czech Republic Czech Republic

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Principal Investigators

Site No: 263 Site No: 264 Rene Turcinek, MD Jirina Vejvodova, MD Kochova 1227/2 Prazska 2189 Havirov-Sumbark 73601 Benesov 25601 Czech Republic Czech Republic

Site No: 266 Site No: 267 Renata Sarbochova, MD Tomas Brabec, MD Politickych veznu 576 Zabrdovicka 3 Slany 27401 Brno 63600 Czech Republic Czech Republic

Site No: 268 Site No: 269 Tomas Krystl, MD Tomas Hrdina, MD Karlovarska 298/30 Nadrazni 521 Plzen 30100 Opocno 51773 Czech Republic Czech Republic

Site No: 270 Site No: 271 Theodora Temelkova-Kurktschiev, MD Anat Jaffe, MD 1, Han Krum Str. P.O Box 169 Floor -1 Sofia 1000 Hadera 84894 Bulgaria Israel

Site No: 272 Site No: 273 Amir Bashkin, MD Julio Wainstein, MD Lohamei HaGeta'ot St 5 62 Halohamin Str. Outpatient building, Floor 1 Nahariya 13100 Holon 22100 Israel Israel

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Principal Investigators

Site No: 316 Site No: 317 Wen-Ying Yang, MD Quan-Min Li, MD No.2 Yinghua East Road, Hepingli, Chaoyang No.16, Xin Jie Kou Wai Street, Xicheng District District Beijing 100088 Beijing 100029 China China

Site No: 323 Site No: 325 Jixiang Dong, MD Andres Francisco Alvarisqueta, MD No.1055, Sanxiang Road Independencia 1475 PB Suzhou Jiangsu215004 Mar del Plata Buenos AiresB7600DHK China Argentina

Site No: 326 Site No: 328 Silvia Beatriz Gorban de Lapertosa, MD Daniel Leonardo Piskorz, MD Necochea 1050 Paraguay 40 3rd Floor Corrientes CorrientesW3410AVV Rosario Santa FeS2000CVB Argentina Argentina

Site No: 329 Site No: 330 Isaac Rubén Sinay, MD Georgina Daniela Sposetti, MD Av Del Libertador 6302 Av Colon 3364 PB CABA Buenos AiresC1428ART Mar del Plata Buenos AiresB7600FZN Argentina Argentina

Site No: 331 Site No: 332 Pedro Rosario Fabián Calella, MD Laura Elena Maffei, MD Colon 776 Godoy Cruz Cerviño 3375 1° floor Mendoza M5501ARP CABA Beunos AiresC1425AGC Argentina Argentina

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Principal Investigators

Site No: 333 Site No: 334 Juan Pablo Cimbaro Canella, MD Silvia Salomé Saavedra, MD Simon Bolivar 1334 Hipólito Irigoyen 273. Salta () Corrientes CorrientesW3400AMZ Salta SaltaA4400CLA Argentina Argentina

Site No: 335 Site No: 336 Maria Rosa Ulla, MD Jorge Norberto Waitman, MD Damaso Larragaña 94 3° floor Avenida Velez Sarfield 576 6° "A" Cordoba CordobaX5000BNB Cordoba CordobaX5003JJR Argentina Argentina

Site No: 337 Site No: 338 Horacio Angel Sessa, MD Luis de Loredo, MD Rioja 2926 Naciones Unidas 346 3rd Floor Rosario Santa FeS2002OJN Cordoba CordobaX5016KEH Argentina Argentina

Site No: 339 Site No: 340 Ricardo Pereira Silva, MD Jose Kerr Saraiva, MD R. Capitao Francisco Pedro, 1290 Av. John Boyd Dunlop, s/nº PUC - Campinas - Campus 2 Fortaleza CE60430-370 Campinas SP13059-740 Brazil Brazil

Site No: 341 Site No: 342 Miguel Nasser Hissa, MD João Lindolfo Cunha Borges, MD Rua Monsenhor Furtado 1438, Sala 101 a 105 SHIS QI 09 Centro Clínico do Lago – Bloco E1 sala Rodolfo Teófilo 304 – Lago sul Fortaleza CE60430-350 Brasilia 71625-009 Brazil Brazil

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Principal Investigators

Site No: 344 Site No: 349 Freddy Goldberg Eliaschewitz, MD Luiz Henrique Maciel Griz, MD Rua Goiás, 193 - Higienópolis Estrada do Arraial, 2723 – Casa Amarela Prédio do Laboratório - 2º andar - sala 206 São Paulo SP01244-030 Recife PE52051-380 Brazil Brazil

Site No: 350 Site No: 351 José Augusto Sgarbi, MD Marcos Tambascia, MD Av. Tiradentes, 1310 Bairro Fragata R. Vital Brasil, 250 Marília SP17519-000 Campinas SP13084-971 Brazil Brazil

Site No: 352 Site No: 353 Silmara Leite, MD Daniel Panarotto, MD Av. Vicente Machado, 1243 Batel Rua Francisco Getúlio Vargas 1130 Curitiba PR80420-011 Caxia do Sul RS95070-560 Brazil Brazil

Site No: 354 Site No: 355 Pedro Pimentel Filho, MD Adriana Costa e Forti, MD Av. Francisco Trein, 596- Bloco A - 5º Andar - Sala Rua Dr. José Lourenço, 2434 Joaquim Távora 01 Fortaleza CE60115-282 Porto Alegre RS91350-200 Brazil Brazil

Site No: 356 Site No: 357 João Soares Felício, MD Fernando Tomás Lanas Zanetti, MD Rua dos Mudurucus 4487 Guamá Av. Freire 550, Block 2, Depto. N° 13. Temuco – Chile Belém PA66073-000 Temuco 4781151 Brazil Chile

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Principal Investigators

Site No: 358 Site No: 359 Claudia Monica Olivares Cañon, MD Sergio Hernán Potthoff Cárdenas, MD Av. Padre Hurtado # 13560, San Bernardo, Santiago - Av. Phillipi 1480, Osorno- Chile Chile Osomo 5311523 Santiago NA Chile Chile

Site No: 363 Site No: 364 Carlos Antonio Raffo Grado, MD Bernhard Henoc Westernerberg Maldonado, MD Av. Libertad N° 798, 5to piso, oficina 503 - 402 Av. Argentina 1962, Viña del Mar NA Antofagasta NA Chile Chile

Site No: 365 Site No: 367 Edgardo Enrique Escobar Cerda, MD Alberto Reyes Rincon, MD Av Santa Rosa 1234, Santiago-Chile. ITMS, Av Diagonal 127 A N°22-27 Of 501-502 Callao 3341, Las Condes Santiago Bogotá No appply Santiago NA Colombia Chile

Site No: 369 Site No: 371 Dora Ines Molina, MD German Anibal Perez Amador, MD Calle 66# 23B-03 Carrera 49 #80-125 Oficina 201 Manizales Barranquilla Atlantico0 Colombia Colombia

Site No: 372 Site No: 374 Julian Alonso Coronel Arroyo, MD Pablo Aschner Montoya, MD Carrera 59 No. 1E - 21 CALI - Diagonal 39 A Bis #14-78 Centro de Investigaciones Cali NA Bogotá NA Colombia Colombia

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Principal Investigators

Site No: 376 Site No: 377 Alice Pik Shan Kong, MD Chiu-Chi Tsang, MD 30-32 Ngan Shing Street Shatin, N.T. 11 Chuen On Road Tai Po Hong Kong 0 Hong Kong 0 Hong Kong Hong Kong

Site No: 378 Site No: 379 Shing-Chung Siu, MD Emmy Yuen-Fun Lau, MD 19 Eastern Hospital Road Causeway Bay 3 Lok Man Road Chai Wan Hong Kong 0 Chai Wan 852 Hong Kong Hong Kong

Site No: 380 Site No: 381 Grace Kam, MD Stephen Lee, MD 130 Hip Wo Street Kwun Tong 102 Pokfulam Road Hong Kong 0 Hong Kong 0 Hong Kong Hong Kong

Site No: 382 Site No: 383 Yat Yin Lam, MD Brian Tomlinson, MD 30-32 Ngan Shing Street Shatin, N.T. 30-32 Ngan Shing Street Shatin, N.T. Hong Kong 0 Hong Kong 0 Hong Kong Hong Kong

Site No: 384 Site No: 385 Andrew Yiu-Yan Ho, MD Vincent Tok-Fai Yeung, MD 23 Tsing Chung Koon Road Tuen Mun 118 Shatin Pass Road Wong Tai Sin Hong Kong 0 Hong Kong 0 Hong Kong Hong Kong

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Principal Investigators

Site No: 386 Site No: 387 Mafauzy Mohamed, MD Nor Azmi Kamaruddin, MD Department of Medicine, School of Medical Sciences UKM Medical Centre Ground Floor Universiti Sains Malaysia Cheras Kuala Lumpur56000 Kubang Kerian Kelantan16150 Malaysia Malaysia

Site No: 388 Site No: 389 Ikram Shah Ismail, MD G.R. Letchuman Ramanathan, MD Tingkat 2 Rawatan Utama Klinik Am (RUKA) , Hospital Taiping Lembah Pantai Taiping Perak34000 Kuala Lumpur 59100 Malaysia Malaysia

Site No: 390 Site No: 391 Kauthaman A. Mahendran, MD Nor Azizah Aziz, MD Jalan Mufti Hj Khalil Hospital Pulau Pinang c/o Penang Medical College Clinical Research Centre 4, Jalan Sepoy Lines Melaka MElaka75400 Penang 10450 Malaysia Malaysia

Site No: 392 Site No: 393 Sree Kantan Nayar P.K.S. Nayar, MD Zawawi Nordin, MD Klinik Kesihatan Greentown Jalan Raja Musa Aziz Hospital Sultanah Nur Zahirah Klinik Pakar Perubatan Ipoh Perak30450 Kuala Terengganu Terengganu20400 Malaysia Malaysia

Site No: 394 Site No: 395 Wayne Huey-Herng Sheu, MD Jung-Fu CHEN, MD No. 160, Sec. 3, Chung-Kang Rd No 123, Ta-Pei Road Taichung 407 Kaohsiung 83301 Taiwan, Province of China Taiwan, Province of China

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Principal Investigators

Site No: 396 Site No: 398 Chien-Wen Chou, MD Chien-Ning HUANG, MD 901 Chung Hwa Road No.110, Sec.1, Chien-Kuo N Rd. Yong Kung City 710 Taichung 40201 Taiwan, Province of China Taiwan, Province of China

Site No: 399 Site No: 400 Dee Pei, MD Lee-Ming CHUANG, MD 362, Chung Cheng Road No.1, Changde St. Hsintien City 23137 Taipei 10048 Taiwan, Province of China Taiwan, Province of China

Site No: 401 Site No: 402 Chen-Ling HUANG, MD Ching-Fai Kwok, MD No.252, Wuxing St. No. 201, Sec. 2, Shih-Pai Road Taipei, Taiwan Taipei 11031 Taipei Taiwan Taiwan, Province of China Taiwan, Province of China

Site No: 403 Site No: 404 Shu-Yi WANG, MD Jitka Hasalova Zapletalova, MD 135 Nanxiao st. Changhua city, Taiwan Palackeho 492 Changhua city 500 Holesov 76901 Taiwan, Province of China Czech Republic

Site No: 406 Site No: 408 Manuel Eduardo Rodriguez Venegas, MD Sergey Levashov, MD Complejo Asistencial Dr.Sótero del Río- v.Concha y 287, Pobedy pr. Toro 3459, Puente Alto Chelyabinsk 454021 Santiago NAP Russian Federation Chile

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Principal Investigators

Site No: 410 Site No: 411 Leslie Robertson, MD Agatha Wilhase, MD Dot Shuttleworth Centre for Diabetes Parklands 0 Arthur Hobbs Street Reiger Park Medical Centre Boksburg Gauteng1459 Durban Kwazulu Natal4001 South Africa South Africa

Site No: 419 Site No: 420 Rob Breedveld, MD Kyung Mook Choi, MD Henri Dunantweg 2 2de verdieping kamer T2-102 148 Gurodong-ro Leeuwarden 8934 AD Seoul 152-703 Netherlands Korea, Republic Of

Site No: 421 Site No: 422 Moonsuk Nam, MD SeonA Shin, MD 7-206 3-ga 2F, DM education room, 153, Gyeongchun-ro Incheon 400-711 Guri Gyeonggi-do471-701 Korea, Republic Of Korea, Republic Of

Site No: 423 Site No: 425 ChoonHee Chung, MD Jin Hee Song, MD 162 Ilsan-dong 9F, Women’s Center, 1198 Guwol-dong Wonju Kangwon-do220-701 Incheon Gyeonggi-do405-760 Korea, Republic Of Korea, Republic Of

Site No: 426 Site No: 427 Seung Jin Han, MD Doo-Man Kim, MD San5 Wonchon-dong 445 Gil-dong Suwon 443-721 Seoul 134-701 Korea, Republic Of Korea, Republic Of

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Principal Investigators

Site No: 429 Site No: 430 Amanda Adler, MD Melanie Davies, MD Box 281 Hills Road Gwendolen Road Cambridge CB2 0QQ Leicester LE5 4PW United Kingdom United Kingdom

Site No: 431 Site No: 432 Jerome Kerrane, MD Alan Jaap, MD 200 Kingscote Drive Royal Infirmary of Edinburgh 52 Little France Crescent Blackpool FY3 7EN Edinburgh EH16 4SA United Kingdom United Kingdom

Site No: 433 Site No: 434 Andrew Johnson, MD Robert Lindsay, MD Southmead Hospital Southmead Road Westernern Infirmary Dumbarton Road Bristol BS10 5NB Glasgow G11 6NT United Kingdom United Kingdom

Site No: 436 Site No: 437 Beverley Millward, MD Rory McCrimmon, MD ITTC Building Davy Road Level 7 Ninewells Drive Plymouth PL6 8BX Dundee DD1 9SY United Kingdom United Kingdom

Site No: 438 Site No: 439 Anthony Robinson, MD Tejpal Purewal, MD Combe Park Prescot Street Bath BA1 3NG Liverpool L7 8XP United Kingdom United Kingdom

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Principal Investigators

Site No: 440 Site No: 441 Mark Blagden, MD Hugh Jones, MD Ashgate Medical Practice/ Avondale Surgery Barnsley Hospital NHS Foundation Trust Gawber Ashgate Road/ 3-5 Avondale Road Road Chesterfield S40 4AA/ S40 4TF Barnsley S75 2EP United Kingdom United Kingdom

Site No: 442 Site No: 443 Jennifer Litchfield, MD Anne Kilvert, MD Pound Hill Medical Group 1 Crawley Lane Cliftonville Western Sussex RH10 7DX Northampton NN1 5BD United Kingdom United Kingdom

Site No: 445 Site No: 447 Jesse Kumar, MD Chinnusamy Ravikumar, MD Maidstone Hospital Hermitage Lane Lincoln County Hospital Greetwell Road Maidstone ME16 9QQ Lincoln LN2 5QY United Kingdom United Kingdom

Site No: 448 Site No: 449 Jola Weaver, MD Philip Wiles, MD Department of Diabetes and Endocrinology Queen Diabetes Centre North Manchester General Hospital Elizabeth Hospital Manchester M8 5RB Gateshead NE9 6SX United Kingdom United Kingdom

Site No: 450 Site No: 451 Prakash Abraham, MD Karen Adamson, MD Health Sciences Building University of Aberdeen Medical Unit St. John's Hospital Aberdeen AB25 2ZN Livingston EH54 6PP United Kingdom United Kingdom

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Principal Investigators

Site No: 452 Site No: 453 Martin Merkel, MD Muhammad Radzi Abu Hassan, MD Lohmuehlenstr. 5, Haus J Hospital Sultanah Bahiyah KM 6 Hamburg 20099 Alor Star KedahO5460 Germany Malaysia

Site No: 454 Site No: 455 Ru San Tan, MD Rinkoo Dalan, MD National Heart Centre Level 10, 5 Hospital Drive Tan Tock Seng Hospital 11, Jalan Tan Tock Seng Singapore 169609 Singapore 308433 Singapore Singapore

Site No: 459 Site No: 460 BingYin SHI, MD Lu Lu Chen, MD No277,Yan Ta Westernern Road No.1095, Jiefang Dadao, Wuhan, 430030, Hubei Province, China Xi'An 710061 Wuhan Hubei430030 China China

Site No: 461 Site No: 462 Shao Xiong Zheng, MD Xu Lei Tang, MD No. 23 Ping Jiang Dao, Hexi District, No1,Dong Gang Westernern Rd,ChengGuan District Tianjin 300211 Lanzhou 730000 China China

Site No: 463 Site No: 0 Vesela Spasova, MD Rumena Bostandzhieva, MD 62, Slavianska St. 59, Ivan Vazov St. Blagoevgrad 2700 Plovdiv 4000 Bulgaria Bulgaria

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Principal Investigators

Site No: 465 Site No: 469 Dimitar Iliev, MD Yulia Samoylova, MD 15A, Vassil Aprilov Blvd. 2, Moskovskiy trakt Plovdiv 4000 Tomsk 634050 Bulgaria Russian Federation

Site No: 470 Site No: 472 Elena Rechkova, MD Vlasta Kutejova, MD 17, Kurchatova ul Na Naspech 78 Krasnoyarsk 660062 Hranice 753 01 Russian Federation Czech Republic

Site No: 473 Site No: 480 Jana Nevrla, MD John Wilding, MD Rybarska 1001 School of Clinical Sciences Clinical Sciences Centre Ujezd u Brna 66453 Liverpool L9 7AL Czech Republic United Kingdom

Site No: 486 Site No: 487 Christine Voors-Pette, MD Mark Daly, MD Mathenesserlaan 247 Royal Devon and Exeter Hospital Barrack Road Rotterdam 3021 HC Exeter EX2 5DW Netherlands United Kingdom

Site No: 489 Site No: 492 CULAK Jan, MD Eduardo Enrique Garces Flores, MD Hviezdoslavova 1 Av Francia 1655, Valdivia- Chile Prievidza 97101 Valdivia 5090134 Slovakia Chile

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Principal Investigators

Site No: 494 Site No: 496 Pablo Arias, MD Roman Zak, MD Mitre 220 Liscie udolie 57 Rosario Santa FéS200COE Bratislava 84105 Argentina Slovakia

Site No: 498 Site No: 499 Laszlo Koranyi, MD Grzegorz Górny, MD Ady Endre ut. 12. Ul. Szarych Szeregów 23B/5 Balatonfüred H-8230 Inowroclaw 88-100 Hungary Poland

Site No: 505 Site No: 506 Svetlana Dora, MD Werner Stürmer, MD 6/8 Lev Tolstoy Schweinfurter Straße 7 Saint-Petersburg 197022 Wuerzburg 97080 Russian Federation Germany

Site No: 510 Site No: 511 Hamish Simpson, MD John McKnight, MD 6-8 High Street Townhead Surgery Wellcome Trust Clinical Research Facility Westernern General Hospital Irvine KA12 0AY Edinburgh EH4 2XU United Kingdom United Kingdom

Site No: 514 Site No: 515 Lia Bernardita Bunster Balocchi, MD Nelson Rassi, MD Miraflores 2085, san Felipe - Chile. Hospital San Rua R17, quadra 17, lote 17 Setor Oeste Camilo Goiânia GO74125-170 San Felipe none Brazil Chile

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Principal Investigators

Site No: 516 Site No: 517 Ana Maria Gómez Medina, MD Tadeusz Skowron, MD Carrera 7 No. 40 - 62 (Centro de Investigación Piso ul. Sosnowa 16 2) Blachownia 42-290 Bogota 0 Poland Colombia

Site No: 523 Site No: 524 Dalisbor Marcelo Weber Silva, MD Wolfram Kamke, MD Rua: Alexandre Döhler, 129 10° andar - sala 1005 Zur Spreewaldklinik 14 Joinville SC89201-260 Burg 3096 Brazil Germany

Site No: 531 Site No: 534 Marc-Alexander Ohlow, MD Natacha Maldonado, MD Robert-Koch-Allee 9 Presidente Roca 744 2nd Floor Bad Berka 99437 Rosario S2000CXP Germany Argentina

Site No: 536 Site No: 537 Sebastián Vélez Pelaez, MD Hernán Yupanqui Lozno, MD Calle 78B N° 69-240 9 Floor (Centro de Carrera 16 A N° 79-33 Investigaciones) Bogotá DC Cundinamarca571 Medellín Antioquia0 Colombia Colombia

Site No: 538 Site No: 539 Iva Mikulkova, MD Eva Racicka, MD Sadova 33 Vratimovska 1 Blansko 67801 Ostrava - Kuncice 70702 Czech Republic Czech Republic

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Principal Investigators

Site No: 540 Site No: 541 Katerina Urbancova, MD Alex Valenzuela Rincon, MD Ceskobratrska 30 Fundación Cardioinfantil-Instituto de Cardiología Calle 163 A N° 13B-60 (Centro de Investigaciones) Ostrava 70200 Bogotá NAP Czech Republic Colombia

Site No: 542 Site No: 544 Francesca Alfonsi, MD Gloria Rojas Lingan, MD Via san Marciano Mathenesserlaan 247 Sora 3039 Rotterdam 3021 HC Italy Netherlands

Site No: 548 Site No: 549 Jurgen Wurziger, MD Maria Carolina Ridruejo, MD Blasewitzerstr.78-80 Av. Córdoba 2424 Dresden 1307 Ciudad Autónoma de Buenos Aires C1120AAT Germany Argentina

Site No: 550 Site No: 551 Alejandra Isabel Oviedo, MD Zsolt Ples, MD J. B. Alberdi 5275 Ap.4 Martirok útja 9. Ciudad Autónoma de Buenos Aires C1440AAD Sátoraljaújhely H-3980 Argentina Hungary

Site No: 552 Site No: 553 Eniko Dezso, MD András Taller, MD Tallián Gy. u. 20-34 Uzsoki u 29-41 Kaposvár H-7400 Budapest H-1145 Hungary Hungary

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Principal Investigators

Site No: 554 Site No: 555 Nóra Késmárki, MD Andrian Yakov, MD Szekeres J u. 2-8 34, Vasil Levski Str. Nagykanizsa H-8800 Gulyantsi 5960 Hungary Bulgaria

Site No: 556 Site No: 557 Snejina Kovacheva, MD Roza Bobeva, MD 60 Nikola Petkov St 1, Hristo Botev Str. Sevlievo 5400 Sliven 8800 Bulgaria Bulgaria

Site No: 558 Site No: 559 Dace Teterovska, MD Inta Leitane, MD Meza prosp.9 Tornakalna policlinic Kokles street 12 Ogre LV5001 Riga LV1002 Latvia Latvia

Site No: 560 Site No: 561 Arcils Gersamija, MD Olga Stetsyuk, MD Alejas 96a Gagarina str, 27B Daugavoils LV-5401 Smolensk 214019 Latvia Russian Federation

Site No: 562 Site No: 563 Galina Ketova, MD Elena Turova, MD 2 Cherkasskaya str 53, Zemlyanoy val ul., Moscow Chelyabinsk 454021 Moscow 105120 Russian Federation Russian Federation

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Principal Investigators

Site No: 564 Site No: 565 Leon Fouche, MD Prabashini Govender, MD Limpopo Clinical Research Initiative Tambotie 1 Glynn Eden Complex CNR Harrison and Princess Medical Centre Street Thabazimbi Limpopo380 Benoni 1500 South Africa South Africa

Site No: 566 Site No: 587 Rudolf Remppis, MD Leslie Tay, MD Bahnhofstrasse 14 2 Simei Street 3 Level 9 Lift Lobby B Weissenhorn 89264 Singapore 529889 Germany Singapore

Site No: 601 Site No: 602 Tomas Brychta, MD Katerina Smolenakova, MD Dlouha 521/34 Litomericka 272 Olomouc 779 00 Steti 411 08 Czech Republic Czech Republic

Site No: 603 Site No: 605 Dana Kafkova, MD Richard Zachoval, MD Husova 128/2 Jungmannova 1132 Caslav 286 01 Jicin 506 01 Czech Republic Czech Republic

Site No: 606 Site No: 607 Marie Hornackova, MD Leonas Valius, MD Delnicka 1222/53 Eiveniu str 2 Brno 624 00 Kaunas LT-50009 Czech Republic Lithuania

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Principal Investigators

Site No: 608 Site No: 609 Egle Varanauskiene, MD Lina Barsiene, MD Pramones str 31 Partizanu 27 D Kaunas LT-51270 Kaunas LT-49456 Lithuania Lithuania

Site No: 612 Site No: 613 Jonas Ceponis, MD Kristina Baltramonaitiene, MD Mindaugo str. 17 Luksio str.3 Trakai LT-21114 Kaunas LT 49387 Lithuania Lithuania

Site No: 622 Site No: 624 Jurate Lasiene, MD Olivier ZIEGLER, MD Paneriu str 121 Service de Diabétologie Maladies Métaboliques rue du Morvan Kaunas LT48426 Vandoeuvre les Nancy 54511 Lithuania France

Site No: 631 Site No: 632 Manuela Thinesse-Mallwitz, MD Agnes Himpel-Boenninghoff, MD Faeustlestrasse 3 Baasdorferstrasse 35 München 80399 Köthen 6366 Germany Germany

Site No: 633 Site No: 634 Martin Braun, MD Sharon Gillings, MD Robert-Koch-Strasse 26 St James' Surgery Northampton Buildings Burghausen 84489 Bath BA1 2SR Germany United Kingdom

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Principal Investigators

Site No: 635 Site No: 641 Thozhukat Sathyapalan, MD Elizabeth Silvana Gelersztein, MD Hull York Medical School, Michael White Diabetes Salguero 2142- 8 Floor Centre, 220-236, Anlaby Road, Ciudad Autonoma de Buenos Aires C1425DES Hull, HU3 2RW Argentina United Kingdom

Site No: 642 Site No: 643 Maria Cecilia Cantero, MD Ana Lía Cagide, MD Rivadavia, 3363 Av da Santa Fe, 3233 - PB 3 Santa Fe S3000SWO Buenos Aires C1425BGH Argentina Argentina

Site No: 645 Site No: 647 Marcela Andrea Cipullo, MD Marisa Liliana Vico, MD Florestano Andrade, 332 Guardias Nacionales, 131 Buenos Aires 2800 Buenos Aires 2900 Argentina Argentina

Site No: 649 Site No: 650 Maria Isabel del Valle Klyver, MD Andrea del Pilar Larrazabal Miranda, MD Avellaneda 700 18 de Septiembre, 1000, Arica - Chile San Miguel de Tucuman TucumanT4000HXT Arica 0 Argentina Chile

Site No: 651 Site No: 652 José Manuel Morales Alvarado, MD Miguel Alberto Urina Triana, MD Francisco Ramirez N° 10, Chillán - Chile. Carrera 50, 80-216 piso 2 Chillan 0 Barranquilla 0 Chile Colombia

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Principal Investigators

Site No: 654 Site No: 655 Rodrigo Botero Lopez, MD Olga Hola, MD Calle 54, 46-27 Suite 1509 Karlovarska trida 30 Medellin antioquia0 Plzen 301 66 Colombia Czech Republic

Site No: 656 Site No: 657 Michaela Vondrakova, MD Ivana Kellnerova, MD 28.rijna 1000 Kollarova 7 Turnov 511 16 Svitavy 568 25 Czech Republic Czech Republic

Site No: 0 Site No: 660 C Pantlikova, MD Ingemar Torstensson, MD MUDr. Jana Janskeho 11 J A Hedlunds Vaeg 5 Znojmo 669 02 Kristianstad 29133 Czech Republic Sweden

Site No: 662 Site No: 663 Enrique Eizyk, MD Michael Alvarsson, MD Sodra Vagen Karolinska universitetssjukhuset, Solna Kliniken för Endokrinologi, Metabolism och Diabetes Angelholm 26281 Stockhom 17176 Sweden Sweden

Site No: 664 Site No: 665 Magnus Löndahl, MD Bas Kietselaer, MD Skånes Universitetssjukhus P. Debyelaan 25 Lund 22185 Maastricht 6229 HX Sweden Netherlands

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Principal Investigators

Site No: 666 Site No: 671 Adriaan Kooy, MD Marta Botella, MD Dr .G. H. Amshoffweg 1 Ctra. Alcal-Meco s/n Servicio de Endocrinologia Hoogeveen 7909 AA Alcala de Henares 28805 Netherlands Spain

Site No: 673 Site No: 674 Francisco Javier Del Cañizo, MD Petter Johansson, MD Avda. Gran Via del este 80 Primera Planta Rosenhälsans vårdcentral Huskvarna vårdcentrum Madrid 28031 Huskvarna 55185 Spain Sweden

Site No: 675 Site No: 676 Ping-Han Lo, MD Bien-Hsien Huang, MD 2 Yuh-Der Road, Taichung City Taiwan 40447 No.117, Shatian Rd., Shalu Township, Taichung County 433 Taichung City 40447 Taiwan 433 Taiwan, Province of China Taiwan, Province of China

Site No: 677 Site No: 678 I-Chang Hsieh, MD Wen-Ter Lai, MD Cardiovascular Office, B2, Building K, Children No.100 , Tzyou 1st Road Kaohsiung Hospital 5, Fu-Shin Street, Kuei Shan Hsiang Kaohsiung 807 Tao-yuan County 33305 Taiwan, Province of China Taiwan, Province of China

Site No: 679 Site No: 680 Ilze Andersone, MD Baiba Jegere, MD Raudas 8 Jumaras street 195 Tukums LV 3100 Valmiera LV-4201 Latvia Latvia

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Principal Investigators

Site No: 685 Site No: 686 Victor Areli Saavedra Gajardo, MD Didier GOUET, MD Paseo Bulnes 79 Of.27 Centre Hospitalier de la Rochelle Hôpital Saint louis Santiago 0 la Rochelle 17019 Chile France

Site No: 687 Site No: 688 Ülle Kaasik, MD Kaja Märtsin, MD Ravi 18F Sõpruse pst 179/181 Tallinn 10138 Tallinn 13415 Estonia Estonia

Site No: 689 Site No: 690 Kaia Kiiroja, MD Riin Lanno, MD Paldiski mnt 68a Paldiski mnt 68a Tallinn 10617 Tallinn 10617 Estonia Estonia

Site No: 691 Site No: 692 Anu Ambos, MD Hella Vides, MD J.Sütiste 19 Pärsti vald Tallinn 13419 Viljandimaa 71024 Estonia Estonia

Site No: 693 Site No: 694 Liina Viitas, MD Marju Past, MD Veetorni 2-1 Sütiste 17 Pärnu 80018 Tallinn 13419 Estonia Estonia

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Principal Investigators

Site No: 695 Site No: 696 Ingrid Alt, MD Elena Ilieva, MD Vee 6 20, Sveto Preobrajenie Str Paide 72713 Sofia 1712 Estonia Bulgaria

Site No: 697 Site No: 698 Galina SHeinikova, MD Zahari Nikitov, MD 1, G. Sofiiski Str., 11, Armeiska Str. Sofia 1431 Stara Zagora 6003 Bulgaria Bulgaria

Site No: 700 Site No: 701 Jørn Ossum Gronert, MD Thomas Karlsson, MD Flattum Legesenter Hønengata 70 A Trondheimsveien 84 Postgården Hønefoss 3515 Kløfta 2040 Norway Norway

Site No: 702 Site No: 703 Kåre Birkeland, MD Sigrun Halvorsen, MD Endokrinologisk avdeling Oslo Universitetssykehus Hjertemedinsk avdeling Oslo Universitetssykehus HF, Aker Ullevål Oslo 514 Oslo 407 Norway Norway

Site No: 704 Site No: 0 Tor Claudi, MD Helge Istad, MD Nordlandssykehuset Prinsens gate 164 Fr. Nansens pl. 7 Bodø 8092 Oslo 160 Norway Norway

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Principal Investigators

Site No: 706 Site No: 707 Adrian Albota, MD Carmina Alexandru, MD Str. Carpatilor nr. 54 Cabinet 29-30 Str Crisului nr 1 Brasov 500269 Brasov 500283 Romania Romania

Site No: 708 Site No: 709 Adriana Dumitrescu, MD Doru Negru, MD Str. Viitorului nr. 44 Str. Spartachiadei, nr 13 Bucuresti 020614 Bucharest 062272 Romania Romania

Site No: 710 Site No: 711 Delia-Adriana Lupusoru, MD Alina NICOLAU, MD Str. Spiru Haret, Nr.2-4 Str. Ion Movila nr. 5 - 7 Bacau 600114 Bucuresti 020475 Romania Romania

Site No: 712 Site No: 713 Alexandrina Popescu, MD Ioan Andrei Veresiu, MD Str. Sighet nr. 4, Ploiesti Str Clinicilor nr 2-4 Ploiesti 100163 Cluj Napoca 400006 Romania Romania

Site No: 716 Site No: 718 Zanariah Hussein, MD Radhakrishna Sothiratnam, MD Presint 7 292, Jalan Haruan 2 Oakland Commercial Centre Putrajaya 62250 Seremban Negeri Sembilan70300 Malaysia Malaysia

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Principal Investigators

Site No: 719 Site No: 720 Hendrik Nortje, MD Douwe De Jong, MD Unit B1 N1 City Mews 34 Bouvardia Street Lynnwood Ridge Goodwood 7460 Pretoria 0014 South Africa South Africa

Site No: 721 Site No: 722 Anne-Marie Stapelberg, MD Grant Nieuwoudt, MD The Enterprise Building The Innovation Hub Intercare Medical Centre Parrow Centre Pretoria Gauteng0087 Parrow 7500 South Africa South Africa

Site No: 723 Site No: 724 Frederik Bester, MD Ayesha Badat, MD Boanerges 1 Coetzee Street Bara Clinical Trial Site C/O Theater & College Road Bloemforntein Free State9301 Soweto 2013 South Africa South Africa

Site No: 727 Site No: 728 André Scheen, MD Luc Van Gaal, MD Domaine Universitaire du Sart Tilman Batiment B35 Universitair Ziekenhuis Antwerpen; Wilrijkstraat 10 - Pharmacologie Clinique Edegem 2650 Liège 4000 Belgium Belgium

Site No: 729 Site No: 730 Bart Keymeulen, MD Annick Van den Bruel, MD Campus Jette; Laarbeeklaan 101 AZ Sint-Jan; Campus Sint-Jan;Ruddershove 10 Brussels 1090 Brugge 8000 Belgium Belgium

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Principal Investigators

Site No: 731 Site No: 732 Marek Rajzer, MD Wojciech Piesiewicz, MD ul S.Batorego 3 ul. Lódzka 82/84 Kraków 31-135 Zgierz 95-100 Poland Poland

Site No: 733 Site No: 735 Andrzej Sawicki, MD Kyu Jeung Ahn, MD Leszno 12 Gangdong-gu, Sangil-dong,149 Warsaw 01-192 Seoul 134-727 Poland Korea, Republic Of

Site No: 736 Site No: 737 Tae Sun Park, MD Kang Seo Park, MD 20 Geonjiro, Deokji-gu 1306 Dunsan-dong Seo-gu Jeonju-si Jeollabuk-do561-712 Daegeon 302-799 Korea, Republic Of Korea, Republic Of

Site No: 738 Site No: 739 In Joo Kim, MD In Kyu Lee, MD 305 Gudeok-ro(1Ga, Ami-dong) Seo-gu Kyungpook National University Hospital 50 Samduk-dong 2-ga, Jung-gu Busan 602-739 Daegu 700-721 Korea, Republic Of Korea, Republic Of

Site No: 740 Site No: 741 Moo Hyun Kim, MD Eun Jung Rhee, MD 26 Daeshingongwon-ro 78 Saemunangil Jongro-gu Busan 602-715 Seoul 110-746 Korea, Republic Of Korea, Republic Of

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Principal Investigators

Site No: 742 Site No: 743 Soon-Jib Yoo, MD Ilan Shimon, MD 2, Sosa-dong, Wonmi-gu Gyeonggi-Do 39 Jabotinski St. Floor 1, Room 175 Bucheon 420-717 Petah Tikva 35251 Korea, Republic Of Israel

Site No: 744 Site No: 746 Faiad Adawi, MD Mahmud Darawsha, MD NAP 35 Rothschild St. 3rd Floor, room 302 Safed 49100 Haifa 84101 Israel Israel

Site No: 747 Site No: 748 Victor Vishlitzky, MD Oscar Minuchin, MD 59 Tshernichovsky St. Clinical Studies Unit, Diabetes and Endocrinology unit Room 117 or 130 hospitalization Building Tel Aviv 38100 Kfar Saba 31096 Israel Israel

Site No: 749 Site No: 750 Naftali Stern, MD Hila Knobler, MD 6 Weitzman St. Hospitalization Building, 13th floor P.O 1 Booth 16 Tel Aviv 76100 Rehovot 62038 Israel Israel

Site No: 751 Site No: 753 Irina Bondar, MD Tatiana Raskina, MD 130, Nemirovicha-Danchenko ul 10, 50th Anniversary of October Novosibirsk 630087 Kemerovo 650099 Russian Federation Russian Federation

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Principal Investigators

Site No: 757 Site No: 758 Maria Górska, MD Åke Ohlsson-Önerud, MD ul. M. Curie-Sklodowskiej 24A Kungsgatan 34, 7tr, Bialystok 15-276 Stockholm 11135 Poland Sweden

Site No: 759 Site No: 760 Timo Lenderink, MD Adam Smialowski, MD Henri Dunantstraat 5 Gebouw V ul. Klonowa 23 Heerlen 6419 PC Ksawerów 95-054 Netherlands Poland

Site No: 761 Site No: 762 Timo Valle, MD Ilkka Kantola, MD Pohjoinen Hesperiankatu 17 C Department of Medicine Kiinamyllynkatu 4-8 Helsinki 00260 Turku 20520 Finland Finland

Site No: 763 Site No: 765 Sakari Nieminen, MD Jorma Strand, MD Itä-Suomen Lääkäritalo (IteLasaretti) Sepänkatu 21 3rd Floor Koljonniemenkatu 2 (4th Floor) Oulu 90100 Kuopio FI-70100 Finland Finland

Site No: 766 Site No: 767 Timo Strandberg, MD Merja Perhonen, MD Lönnrotinkatu 32 D 42 Heikinkatu 3 B Helsinki 00180 Jyväskylä 40100 Finland Finland

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Principal Investigators

Site No: 770 Site No: 771 Salvatore Novo, MD Donatella Zavaroni Zavaroni, MD Via Del Vespro, 139 Via Taverna, 49 Palermo 90144 Piacenza 29100 Italy Italy

Site No: 772 Site No: 774 Alessandro Salvioni, MD Gabriela SERBAN, MD Via Parea, 34 Vasile Lupu nr 2 Milano 20158 Ploiesti 100018 Italy Romania

Site No: 775 Site No: 778 Mihaela VOITEC, MD Chantal Mathieu, MD Str. I. L. Caragiale nr 12 Universitair Ziekenhuis Leuven; Campus Gasthuisberg;Herestraat 49 Bucuresti 020045 Leuven 3000 Romania Belgium

Site No: 779 Site No: 780 Olivier Descamps, MD Laurent Crenier, MD Polyclinique du Centre Hospitalier de Jolimont; 159, Route de Lennik 808; Rue Ferrer Brussels 1070 Haine Saint-Paul 7100 Belgium Belgium

Site No: 781 Site No: 782 Frank Nobels, MD Tonny Hayek, MD Onze Lieve Vrouwziekenhuis (OLV);OLV Campus 8 Ha'alia St. Bat Galim, Main Building, internal Aalst Endocrinologie; Moorselbaan 164 medicine E, 1st floor Aalst 9300 Haifa 44281 Belgium Israel

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Principal Investigators

Site No: 783 Site No: 784 Fulden Sarac, MD Ilhan Tarkun, MD Edge Universitesi Tip Fakultesi Ic Hastaliklari Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali Bornova Anabilim Dali Umuttepe Izmir 35100 Kocaeli 41380 Turkey Turkey

Site No: 785 Site No: 786 Mustafa Araz, MD Abdurrahman Comlekci, MD Gaziantep Universitesi Tip Fakultesi Ic Hastaliklari Dokuz Eylul UTF Ic Hastaliklari Anabilim Dali Anabilim Dali Sahinbey Inciralti Gaziantep 27310 Izmir 35340 Turkey Turkey

Site No: 787 Site No: 788 Ibrahim Sahin, MD Tuncay Delibasi, MD Inonu Universitesi Tip Fakultesi Ic Hastaliklari Ankara Diskapi Yildirim Beyazit Egitim Arastirma Anabilim Dali Merkez Kampusu Hastanesi Ic Hastaliklari Klinigi Irfan Bastug Caddesi Diskapi Malatya 44280 Ankara 6010 Turkey Turkey

Site No: 789 Site No: 790 Kubilay Ukinc, MD Okan Bakiner, MD Canakkale Onsekiz Mart Universitesi Tip Fakultesi Baskent Universitesi Adana Uygulama ve Arastirma Ic Hastaliklari Anabilim Dali Canakkale Merkezi Ic Hastaliklari Anabilim Dali Yuregir Canakkale 17110 Adana 1250 Turkey Turkey

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Principal Investigators

Site No: 791 Site No: 792 Murat Yilmaz, MD Serdar Guler, MD Namik Kemal Universitesi Tip Fakultesi Arastirma Ankara Numune Egitim Arastirma Hastanesi Ic ve Uygulama Hastanesi Ic Hastaliklari Anabilim Dali Hastaliklari Klinigi Altindag Merkez Ankara 6100 Tekirdag 59100 Turkey Turkey

Site No: 794 Site No: 795 Janna Dshabrailov, MD Valda Stalte, MD Krahnstrasse 3 Rugena street 2 Osnabrück 49074 Talsi LV3201 Germany Latvia

Site No: 796 Site No: 797 Michael Shechter, MD Ilana Harman-Boehm, MD Tel HaShomer Itzchak Rager Blvd Ramat Gan 52621 Beer Sheba 49100 Israel Israel

Site No: 802 Site No: 804 Tao Yang, MD Xiaohui Guo, MD No.300,Gu Lou district Guangzhou Road No. 8, Western Shiku street, Xicheng District, Beijing, China Nanjing Jiangsu210029 Beijing 100034 China China

Site No: 806 Site No: 808 Davide Lauro, MD Giuseppe Lembo, MD Viale Oxford 81 Via Atinense, 18 Roma 133 Pozzilli (Isernia) 86077 Italy Italy

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Principal Investigators

Site No: 809 Site No: 810 Fernando Civeira Murillo, MD Carlos Trescolí Serrano, MD Laboratorio de Investigacion Molecular. Av Isabel la Servicio de Medicina Interna Unidad Diabetes Católica n 1-3 planta calle/ Hospital general. (Consulta 33) Ctra. Corbera km 1 Zaragoza 50009 Alzira Valencia46600 Spain Spain

Site No: 811 Site No: 812 Blas Gil Extremera, MD Francisco Tinahones Madueño, MD Pabellón Quirúrgico, 3ª planta. Avda Doctor Olóriz Servicio de Endocrinología. 2ª planta, puerta 4 nº 16 Málaga 29006 Granada 18012 Spain Spain

Site No: 813 Site No: 816 Esteban Jodar Gimeno, MD Sergio Leotta, MD C/Diego de Velázquez, 1 Via dei Monti Tiburtini, 385 Palazzina B Piano -1 Pozuelo de Alarcon,Madrid 28223 Roma 157 Spain Italy

Site No: 817 Site No: 818 Malgorzata Arciszewska, MD Tomasz Blicharski, MD ul. Zamenhofa 10 lok 20 ul. Lotnikow Polskich 82 Bialystok 15-435 Swidnik 21-040 Poland Poland

Site No: 819 Site No: 820 Dariusz Pasternak, MD Ewa Krzyzagorska, MD Ul. Widok 31 ul. Murawa 37A Krakow 31-567 Poznan 61-655 Poland Poland

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Principal Investigators

Site No: 821 Site No: 822 Ewa Jazwinska-Tarnawska, MD Magdalena Przekwas-Jaruchowska, MD ul. Swobodna 8a ul. Wladyslawa IV 59 Wroclaw 50-088 Gdynia 81-384 Poland Poland

Site No: 823 Site No: 824 Magda Dabrowska, MD Elzbieta Blach, MD ul. Leszno 12 ul. Konckiego 3 Warszawa 01-192 Katowice 04-040 Poland Poland

Site No: 825 Site No: 826 Peter Mayr, MD Thomas Behnke, MD Mozartstr. 4 Langendorfer Str. 82a Stockach 78333 Neuwied 56564 Germany Germany

Site No: 827 Site No: 828 Joerg Luedemann, MD Ulrich Overhoff, MD Poststr. 46 Pfarrstr. 2-4 Falkensee 14612 Siegen 57072 Germany Germany

Site No: 829 Site No: 0 Ludger Rose, MD Gerhard Stuchlik, MD Hohenzollernring 70 Stadtplatz 43 Münster 48145 Vilshofen 94474 Germany Germany

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Principal Investigators

Site No: 832 Site No: 833 Lesley Burgess, MD Visvakuren Naidoo, MD Room 41, 8th Floor Tygerberg Hospital 8 Flamco Terrace Bayview Parrow WC7505 Durban Kwazulu Natal4092 South Africa South Africa

Site No: 834 Site No: 835 Uttam Govind, MD Yvonne Trinder, MD 468 Randles Road Sydenham J46 41 Old Main Building Durban Kwazulu-Natal4091 Cape Town Westernern Cape7925 South Africa South Africa

Site No: 836 Site No: 837 Anders Gillblad, MD Ulf Sundström, MD Glimmervägen 5e Sjukhusvägen 81 Umeå 907 40 Bollnäs 821 31 Sweden Sweden

Site No: 840 Site No: 841 Aslak Rautio, MD Jolanta Pentela-Nowicka, MD Varvsgatan 53 Al. Pilsudskiego 9 Luleå 972 33 Lodz 90-368 Sweden Poland

Site No: 842 Site No: 852 Anna Salamon-Ferenc, MD Thierry Couffinhal, MD Al. Dzieci Polskich 20 Hôpital Haut-Lévêque CIC cardiovasculaire Rez de Chaussée Avenue Magellan Warszawa 04-730 PESSAC 33604 Poland France

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Principal Investigators

Site No: 854 Site No: 855 Shmuel Fuchs, MD Anat Tsur, MD 39 Jabotinsky Street P.O.B. 85 8 Hanania St. Mochava Germanit Petach Tikva 64239 Jerusalem 93106 Israel Israel

Site No: 856 Site No: 857 Morris Mosseri, MD Galina Abramov, MD 59 Tchernichovsky St. 1 Saalad Kfar Saba 44281 Beer Sheva 58100 Israel Israel

Site No: 858 Site No: 859 Tatiana Morugova, MD Farida Valeeva, MD 2 Shafieva str. 11, Mushtari street Ufa 450083 Kazan 420030 Russian Federation Russian Federation

Site No: 860 Site No: 861 Tatiana Tretyakova, MD Sveltana Mustafina, MD 14, Yadrintsevskaya str. 175/1, B. Bogatkova str. Novosibirsk 630099 Novosibirsk 630089 Russian Federation Russian Federation

Site No: 862 Site No: 863 Olga Sazonova, MD Olga Ershova, MD 6, Zalesskogo str Zagorodny sad 11 Novosibirsk 630047 Yaroslavl 150003 Russian Federation Russian Federation

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Principal Investigators

Site No: 864 Site No: 865 Petr Chizhov, MD Marianne Viljoen, MD Semashko str. 7 182 Watermeyer Street Meyerspark Yaroslavl 150002 Pretoria GAuteng184 Russian Federation South Africa

Site No: 866 Site No: 867 Peter Harvey, MD Wayne Turner, MD 45 Station Road Tilton Road Burbage Surgery Addlestone SurreyKT 15 2BH Hinckley LeicestershireLE10 2SE United Kingdom United Kingdom

Site No: 868 Site No: 871 Charles Bundy, MD Mayura Deshpande, MD Prospect Place North London Clinical Studies Centre Batchworth House Trowbridge WiltshireBA14 8QA Northwood MiddlesexHA6 2RN United Kingdom United Kingdom

Site No: 872 Site No: 873 Tomas Ko, MD Veronika Horvathova, MD 24 EATON AVENUE Matrix Park 1ST FLOOR WILLIAMS HOUSE Manchester Science Park Chorley LancashirePR7 7NA Manchester M15 6SX United Kingdom United Kingdom

Site No: 874 Site No: 875 Essam Abdulhakim, MD Babatunde Oyesile, MD BURLINGTON HOUSE Crosby BIRMINGHAM RESEARCH PARK Vincent Drive Liverpool L22 0LG Birmingham B15 2SQ United Kingdom United Kingdom

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Principal Investigators

Site No: 876 Site No: 877 Veronika Horvathova, MD Dani Hristova, MD VENTURE BUILDING, 1ST FLOOR 1 Kelvin WELLINGTON HOUSE Worton Drive Campus Reading BerkshireRG2 0TG Glasgow G20 0SP United Kingdom United Kingdom

Site No: 878 Site No: 879 Hawys Thomas, MD Carlos Alberto Cure, MD 1/2 Purbeck House Lambourne Crescent Calle 59 # 72 - 115 Cardiff CF14 5GJ Barranquilla 10074 United Kingdom Colombia

Site No: 918 Site No: 919 Ioana Emilia Ferariu, MD Carmen Crisan, MD Str.Calea Bucuresti, nr.62 sc.A, parter, ap.3 Str.Str. Gh. Marinescu nr.8/A, Ap. II Brasov 500365 Tg. Mures 540142 Romania Romania

Site No: 920 Site No: 921 Ella Pintiliei, MD Mircea Munteanu, MD Str. Pacurari, Nr. 70 Bloc 550, parter Str. Samuil Micu, Nr. 9 Iasi 700547 Timisoara 300371 Romania Romania

Site No: 923 Site No: 924 Iris Westernendorp, MD Eelko Ronner, MD Vondellaan 13 Reinier de Graafweg 3 Beverwijk 1942 LE Delft 2625 AD Netherlands Netherlands

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Principal Investigators

Site No: 925 Site No: 926 Frank Den Hartog, MD Maarten Van Hessen, MD Willy Brandtlaan 10 Bleulandweg 10 Ede 6716 RP Gouda 2803 HH Netherlands Netherlands

Site No: 927 Site No: 928 Hugo Beijerbacht, MD Jaap Remmen, MD Jan Weitkamplaan 4-a Weg door Jonkerbos 100 Hardenberg 7772 SE Nijmegen 6532 SZ Netherlands Netherlands

Site No: 929 Site No: 930 Pieter Nierop, MD Robert Van der Heijden, MD Kleiweg 500 Vlietlandplein 2 Rotterdam 3045 PM Schiedam 3118 JH Netherlands Netherlands

Site No: 931 Site No: 941 Walter Hermans, MD Jana Havelkova, MD Hilvarenbeekseweg 60 Vidomcova 1/3741 Tilburg 5022 GC Znojmo 669 02 Netherlands Czech Republic

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