Effect of Efpeglenatide on Cardiovascular Outcomes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT03496298
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
Secondary Objectives:
To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:
* 3-point MACE.
* Expanded CV outcome.
* Composite outcome of new or worsening nephropathy.
To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
- Detailed Description
The study duration per participant was up to approximately 36 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4076
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment. Efpeglenatide 4 mg Efpeglenatide (SAR439977) Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment. Efpeglenatide 6 mg Efpeglenatide (SAR439977) Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
- Primary Outcome Measures
Name Time Method Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
- Secondary Outcome Measures
Name Time Method Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months) Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (\>) 300, as measured in mg of albumin to grams of creatinine, or \>33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m\^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.
Trial Locations
- Locations (353)
Investigational Site Number 8400096
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 8400021
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 3560005
🇮🇳Pune, India
Investigational Site Number 6160014
🇵🇱Tychy, Poland
Investigational Site Number 4400003
🇱🇹Klaipeda, Lithuania
Investigational Site Number 6160006
🇵🇱Plock, Poland
Investigational Site Number 4840015
🇲🇽Durango, Mexico
Investigational Site Number 6040007
🇵🇪Lima, Peru
Investigational Site Number 6040001
🇵🇪Lima, Peru
Investigational Site Number 4840006
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840003
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840005
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840001
🇲🇽Monterrey, Mexico
Investigational Site Number 7030008
🇸🇰Roznava, Slovakia
Investigational Site Number 8040003
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8040002
🇺🇦Kharkiv, Ukraine
Investigational Site Number 4840010
🇲🇽Monterrey, Mexico
Investigational Site Number 5780002
🇳🇴Hamar, Norway
Investigational Site Number 6040002
🇵🇪Piura, Peru
Investigational Site Number 6160005
🇵🇱Katowice, Poland
Investigational Site Number 6160009
🇵🇱Torun, Poland
Investigational Site Number 6420009
🇷🇴Bucuresti, Romania
Investigational Site Number 6160010
🇵🇱Szczecin, Poland
Investigational Site Number 6420005
🇷🇴Oradea, Romania
Investigational Site Number 7030003
🇸🇰Kralovsky Chlmec, Slovakia
Investigational Site Number 8040007
🇺🇦Kiev, Ukraine
Investigational Site Number 8040008
🇺🇦Kyiv, Ukraine
Investigational Site Number 8400046
🇺🇸Tucson, Arizona, United States
Investigational Site Number 8400085
🇺🇸Northridge, California, United States
Investigational Site Number 8400014
🇺🇸Gilbert, Arizona, United States
Investigational Site Number 8400065
🇺🇸Concord, California, United States
Investigational Site Number 8400084
🇺🇸Long Beach, California, United States
Investigational Site Number 8400032
🇺🇸Sheffield, Alabama, United States
Investigational Site Number 8400023
🇺🇸Waterbury, Connecticut, United States
Investigational Site Number 8400073
🇺🇸Hudson, Florida, United States
Investigational Site Number 8400060
🇺🇸Greenbrae, California, United States
Investigational Site Number 1000006
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 8400012
🇺🇸Surprise, Arizona, United States
Investigational Site Number 8400051
🇺🇸Miami, Florida, United States
Investigational Site Number 8400022
🇺🇸Beverly Hills, California, United States
Investigational Site Number 8400006
🇺🇸Macon, Georgia, United States
Investigational Site Number 8400040
🇺🇸Hollywood, Florida, United States
Investigational Site Number 8400002
🇺🇸Los Gatos, California, United States
Investigational Site Number 8400077
🇺🇸Owensboro, Kentucky, United States
Investigational Site Number 8400070
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8400064
🇺🇸Englewood, Colorado, United States
Investigational Site Number 8400091
🇺🇸Hialeah, Florida, United States
Investigational Site Number 8400019
🇺🇸Hamden, Connecticut, United States
Investigational Site Number 8400036
🇺🇸Crystal Lake, Illinois, United States
Investigational Site Number 8400095
🇺🇸Arlington Heights, Illinois, United States
Investigational Site Number 8400028
🇺🇸Great Falls, Montana, United States
Investigational Site Number 8400030
🇺🇸New Albany, Indiana, United States
Investigational Site Number 8400056
🇺🇸Staten Island, New York, United States
Investigational Site Number 8400097
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400093
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 8400082
🇺🇸Pomona, California, United States
Investigational Site Number 8400086
🇺🇸Kalispell, Montana, United States
Investigational Site Number 8400041
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 0320004
🇦🇷Corrientes, Argentina
Investigational Site Number 0320017
🇦🇷Rosario, Argentina
Investigational Site Number 1000017
🇧🇬Gabrovo, Bulgaria
Investigational Site Number 1000007
🇧🇬Kazanlak, Bulgaria
Investigational Site Number 0320006
🇦🇷Merlo, Argentina
Investigational Site Number 8400031
🇺🇸Columbus, Ohio, United States
Investigational Site Number 8400027
🇺🇸Miami, Florida, United States
Investigational Site Number 8400001
🇺🇸Flint, Michigan, United States
Investigational Site Number 8400011
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 0320010
🇦🇷Caba, Argentina
Investigational Site Number 8400029
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 8400034
🇺🇸Alexandria, Louisiana, United States
Investigational Site Number 8400007
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 0320012
🇦🇷Corrientes, Argentina
Investigational Site Number 8400061
🇺🇸Flint, Michigan, United States
Investigational Site Number 0320011
🇦🇷Godoy Cruz, Argentina
Investigational Site Number 8400069
🇺🇸Houston, Texas, United States
Investigational Site Number 8400079
🇺🇸Monroe, Louisiana, United States
Investigational Site Number 8400016
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 8400017
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8400042
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8400071
🇺🇸Billings, Montana, United States
Investigational Site Number 8400078
🇺🇸Lorain, Ohio, United States
Investigational Site Number 8400033
🇺🇸Waco, Texas, United States
Investigational Site Number 8400081
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 0320009
🇦🇷Buenos Aires, Argentina
Investigational Site Number 3480011
🇭🇺Budapest, Hungary
Investigational Site Number 1240024
🇨🇦Chicoutimi, Canada
Investigational Site Number 8400094
🇺🇸Morganton, North Carolina, United States
Investigational Site Number 0320013
🇦🇷Caba, Argentina
Investigational Site Number 0320001
🇦🇷Capital Federal, Argentina
Investigational Site Number 8400058
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 1240007
🇨🇦Calgary, Canada
Investigational Site Number 1000016
🇧🇬Yambol, Bulgaria
Investigational Site Number 8400089
🇺🇸Houston, Texas, United States
Investigational Site Number 1240014
🇨🇦Montreal, Canada
Investigational Site Number 0320015
🇦🇷Rosario, Argentina
Investigational Site Number 1240013
🇨🇦Toronto, Canada
Investigational Site Number 1240027
🇨🇦Peterborough, Canada
Investigational Site Number 1000008
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 1000003
🇧🇬Sofia, Bulgaria
Investigational Site Number 3800006
🇮🇹Catania, Italy
Investigational Site Number 6040003
🇵🇪Lima, Peru
Investigational Site Number 0320008
🇦🇷Capital Federal, Argentina
Investigational Site Number 1000012
🇧🇬Ruse, Bulgaria
Investigational Site Number 0320016
🇦🇷San Isidro, Argentina
Investigational Site Number 1000002
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 1240004
🇨🇦Concord, Canada
Investigational Site Number 1000009
🇧🇬Varna, Bulgaria
Investigational Site Number 1000010
🇧🇬Lovech, Bulgaria
Investigational Site Number 0320014
🇦🇷Santa Rosa, Argentina
Investigational Site Number 3560002
🇮🇳Gurgaon, India
Investigational Site Number 3480005
🇭🇺Budapest, Hungary
Investigational Site Number 1240001
🇨🇦Barrie, Canada
Investigational Site Number 1240017
🇨🇦Montreal, Canada
Investigational Site Number 1240010
🇨🇦Quebec, Canada
Investigational Site Number 1520002
🇨🇱Santiago, Chile
Investigational Site Number 3560001
🇮🇳Belgaum, India
Investigational Site Number 3560007
🇮🇳Kolkata, India
Investigational Site Number 3560010
🇮🇳Pune, India
Investigational Site Number 3480012
🇭🇺Balatonfüred, Hungary
Investigational Site Number 3800001
🇮🇹Milano, Italy
Investigational Site Number 3480003
🇭🇺Budapest, Hungary
Investigational Site Number 3560004
🇮🇳Vellore, India
Investigational Site Number 1520003
🇨🇱Santiago, Chile
Investigational Site Number 3560006
🇮🇳Lucknow, India
Investigational Site Number 4100002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 3480001
🇭🇺Budapest, Hungary
Investigational Site Number 3480006
🇭🇺Budapest, Hungary
Investigational Site Number 3560003
🇮🇳New Delhi, India
Investigational Site Number 4840009
🇲🇽Aguascalientes, Mexico
Investigational Site Number 4840014
🇲🇽Chihuahua, Mexico
Investigational Site Number 6160012
🇵🇱Gdansk, Poland
Investigational Site Number 6160013
🇵🇱Skorzewo, Poland
Investigational Site Number 3800003
🇮🇹Catanzaro, Italy
Investigational Site Number 3480002
🇭🇺Debrecen, Hungary
Investigational Site Number 4100009
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 3480004
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 4100001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4280004
🇱🇻Daugavpils, Latvia
Investigational Site Number 3800005
🇮🇹Catanzaro, Italy
Investigational Site Number 4100011
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100006
🇰🇷Guri-si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 4280003
🇱🇻Sigulda, Latvia
Investigational Site Number 4400001
🇱🇹Kaunas, Lithuania
Investigational Site Number 4400004
🇱🇹Vilnius, Lithuania
Investigational Site Number 6040004
🇵🇪Lima, Peru
Investigational Site Number 6040006
🇵🇪Lima, Peru
Investigational Site Number 4100010
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100007
🇰🇷Busan, Korea, Republic of
Investigational Site Number 7030009
🇸🇰Moldava Nad Bodvou, Slovakia
Investigational Site Number 7030010
🇸🇰Pezinok, Slovakia
Investigational Site Number 8040009
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 8040005
🇺🇦Vinnytsya, Ukraine
Investigational Site Number 6040005
🇵🇪Lima, Peru
Investigational Site Number 6160016
🇵🇱Gdansk, Poland
Investigational Site Number 6430012
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6430016
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number 6160017
🇵🇱Bialystok, Poland
Investigational Site Number 6160018
🇵🇱Bydgoszcz, Poland
Investigational Site Number 6160015
🇵🇱Bydgoszcz, Poland
Investigational Site Number 6160002
🇵🇱Warszawa, Poland
Investigational Site Number 6420012
🇷🇴Oradea, Romania
Investigational Site Number 6430017
🇷🇺Krasnogorsk, Russian Federation
Investigational Site Number 6430010
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 6160011
🇵🇱Skierniewice, Poland
Investigational Site Number 6160004
🇵🇱Wroclaw, Poland
Investigational Site Number 6880001
🇷🇸Belgrade, Serbia
Investigational Site Number 6880003
🇷🇸Belgrade, Serbia
Investigational Site Number 6430019
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 7030001
🇸🇰Kosice, Slovakia
Investigational Site Number 6430018
🇷🇺Kaliningrad, Russian Federation
Investigational Site Number 7240008
🇪🇸Alcorcón, Spain
Investigational Site Number 6880002
🇷🇸Belgrade, Serbia
Investigational Site Number 6430002
🇷🇺Moscow, Russian Federation
Investigational Site Number 6420002
🇷🇴Târgu-Mureş, Romania
Investigational Site Number 6420003
🇷🇴Târgu-Mureş, Romania
Investigational Site Number 7030002
🇸🇰Trebisov, Slovakia
Investigational Site Number 6430013
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 6430009
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 6430006
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 7030006
🇸🇰Povazska Bystrica, Slovakia
Investigational Site Number 7520004
🇸🇪Kristianstad, Sweden
Investigational Site Number 7240005
🇪🇸Olot, Spain
Investigational Site Number 7240003
🇪🇸San Sebastián De Los Reyes, Spain
Investigational Site Number 7240013
🇪🇸Sevilla, Spain
Investigational Site Number 7240001
🇪🇸Madrid, Spain
Investigational Site Number 7520005
🇸🇪Skövde, Sweden
Investigational Site Number 8040006
🇺🇦Dnipro, Ukraine
Investigational Site Number 8400009
🇺🇸Nashville, Tennessee, United States
Investigational Site Number 8400039
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 2080001
🇩🇰Hellerup, Denmark
Investigational Site Number 2080003
🇩🇰Hvidovre, Denmark
Investigational Site Number 1240008
🇨🇦Montreal, Canada
Investigational Site Number 1240019
🇨🇦Red Deer, Canada
Investigational Site Number 1240009
🇨🇦Victoriaville, Canada
Investigational Site Number 4100008
🇰🇷Wonju, Korea, Republic of
Investigational Site Number 8400045
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 1000013
🇧🇬Kyustendil, Bulgaria
Investigational Site Number 1000005
🇧🇬Sofia, Bulgaria
Investigational Site Number 2760002
🇩🇪Pirna, Germany
Investigational Site Number 3480008
🇭🇺Mosonmagyaróvár, Hungary
Investigational Site Number 3480009
🇭🇺Komárom, Hungary
Investigational Site Number 3480007
🇭🇺Székesfehérvár, Hungary
Investigational Site Number 0320007
🇦🇷Mar Del Plata, Argentina
Investigational Site Number 0320018
🇦🇷Salta, Argentina
Investigational Site Number 8400059
🇺🇸Ormond Beach, Florida, United States
Investigational Site Number 4100003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 8400072
🇺🇸Bend, Oregon, United States
Investigational Site Number 8400008
🇺🇸Roswell, Georgia, United States
Investigational Site Number 8400074
🇺🇸Topeka, Kansas, United States
Investigational Site Number 8400037
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 8400063
🇺🇸Murrells Inlet, South Carolina, United States
Investigational Site Number 8400043
🇺🇸Paris, Kentucky, United States
Investigational Site Number 8400010
🇺🇸Troy, Michigan, United States
Investigational Site Number 8400024
🇺🇸Saint Paul, Minnesota, United States
Investigational Site Number 8400049
🇺🇸Manitowoc, Wisconsin, United States
Investigational Site Number 8400044
🇺🇸Rapid City, South Dakota, United States
Investigational Site Number 6430020
🇷🇺Saratov, Russian Federation
Investigational Site Number 8400047
🇺🇸Oxon Hill, Maryland, United States
Investigational Site Number 8400005
🇺🇸Troy, Michigan, United States
Investigational Site Number 8400087
🇺🇸Raritan, New Jersey, United States
Investigational Site Number 8400076
🇺🇸Greenville, North Carolina, United States
Investigational Site Number 8400055
🇺🇸Corpus Christi, Texas, United States
Investigational Site Number 1240029
🇨🇦Mirabel, Canada
Investigational Site Number 0320002
🇦🇷Caba, Argentina
Investigational Site Number 8400052
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 0320005
🇦🇷Caba, Argentina
Investigational Site Number 0320003
🇦🇷Salta, Argentina
Investigational Site Number 1000011
🇧🇬Blagoevgrad, Bulgaria
Investigational Site Number 1000014
🇧🇬Dimitrovgrad, Bulgaria
Investigational Site Number 1000001
🇧🇬Sofia, Bulgaria
Investigational Site Number 1240018
🇨🇦Burlington, Canada
Investigational Site Number 1240020
🇨🇦Calgary, Canada
Investigational Site Number 1240002
🇨🇦Brampton, Canada
Investigational Site Number 1240021
🇨🇦Burlington, Canada
Investigational Site Number 1240025
🇨🇦London, Canada
Investigational Site Number 1240028
🇨🇦London, Canada
Investigational Site Number 1240011
🇨🇦Levis, Canada
Investigational Site Number 1240005
🇨🇦Etobicoke, Canada
Investigational Site Number 1240031
🇨🇦Montreal, Canada
Investigational Site Number 1240023
🇨🇦Montreal, Canada
Investigational Site Number 1240015
🇨🇦Oakville, Canada
Investigational Site Number 1240012
🇨🇦Oshawa, Canada
Investigational Site Number 1240016
🇨🇦Pointe-Claire, Canada
Investigational Site Number 1240022
🇨🇦Sudbury, Canada
Investigational Site Number 1240030
🇨🇦Ottawa, Canada
Investigational Site Number 1240006
🇨🇦Sherbrooke, Canada
Investigational Site Number 1240003
🇨🇦Vancouver, Canada
Investigational Site Number 1520012
🇨🇱Antofagasta, Chile
Investigational Site Number 1240026
🇨🇦Victoria, Canada
Investigational Site Number 1520014
🇨🇱Santiago, Chile
Investigational Site Number 2080004
🇩🇰Aarhus N, Denmark
Investigational Site Number 2080005
🇩🇰Esbjerg, Denmark
Investigational Site Number 1520010
🇨🇱Santiago, Chile
Investigational Site Number 2080002
🇩🇰København Nv, Denmark
Investigational Site Number 1520005
🇨🇱Santiago, Chile
Investigational Site Number 1520006
🇨🇱Temuco, Chile
Investigational Site Number 2330003
🇪🇪Viljandi, Estonia
Investigational Site Number 2330002
🇪🇪Pärnu, Estonia
Investigational Site Number 2460001
🇫🇮Jyväskylä, Finland
Investigational Site Number 2460002
🇫🇮Helsinki, Finland
Investigational Site Number 2460004
🇫🇮Oulu, Finland
Investigational Site Number 2760004
🇩🇪Essen, Germany
Investigational Site Number 2760008
🇩🇪Frankfurt Am Main, Germany
Investigational Site Number 2760006
🇩🇪Berlin, Germany
Investigational Site Number 2760009
🇩🇪Berlin, Germany
Investigational Site Number 2760003
🇩🇪Oldenburg In Holstein, Germany
Investigational Site Number 2760007
🇩🇪Rotenburg An Der Fulda, Germany
Investigational Site Number 2760005
🇩🇪Münster, Germany
Investigational Site Number 3800004
🇮🇹Roma, Italy
Investigational Site Number 3800002
🇮🇹Chieti, Italy
Investigational Site Number 4280002
🇱🇻Liepāja, Latvia
Investigational Site Number 4280001
🇱🇻Riga, Latvia
Investigational Site Number 4400002
🇱🇹Kaunas, Lithuania
Investigational Site Number 4840002
🇲🇽Cuernavaca, Mexico
Investigational Site Number 4840007
🇲🇽Aguascalientes, Mexico
Investigational Site Number 4840013
🇲🇽Aguascalientes, Mexico
Investigational Site Number 5780001
🇳🇴Oslo, Norway
Investigational Site Number 4840016
🇲🇽Durango, Mexico
Investigational Site Number 4840011
🇲🇽Monterrey, Mexico
Investigational Site Number 5780003
🇳🇴Stavanger, Norway
Investigational Site Number 6420011
🇷🇴Brasov, Romania
Investigational Site Number 6420001
🇷🇴Brasov, Romania
Investigational Site Number 6420010
🇷🇴Oradea, Romania
Investigational Site Number 6420008
🇷🇴Ploiesti, Romania
Investigational Site Number 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430014
🇷🇺Kazan, Russian Federation
Investigational Site Number 6430001
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 6430015
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430011
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 6430003
🇷🇺Saratov, Russian Federation
Investigational Site Number 6880005
🇷🇸Belgrade, Serbia
Investigational Site Number 6880004
🇷🇸Kragujevac, Serbia
Investigational Site Number 7030007
🇸🇰Bratislava, Slovakia
Investigational Site Number 7030004
🇸🇰Kosice, Slovakia
Investigational Site Number 6880006
🇷🇸Novi Sad, Serbia
Investigational Site Number 7030005
🇸🇰Presov, Slovakia
Investigational Site Number 7030011
🇸🇰Sturovo, Slovakia
Investigational Site Number 7030012
🇸🇰Trencin, Slovakia
Investigational Site Number 7100005
🇿🇦Cape Town, South Africa
Investigational Site Number 7100007
🇿🇦Bloemfontein, South Africa
Investigational Site Number 7100003
🇿🇦Johannesburg, South Africa
Investigational Site Number 7100006
🇿🇦Cape Town, South Africa
Investigational Site Number 7100001
🇿🇦Johannesburg, South Africa
Investigational Site Number 7100002
🇿🇦Parow, South Africa
Investigational Site Number 7100004
🇿🇦Rivonia, South Africa
Investigational Site Number 7240002
🇪🇸Barcelona, Spain
Investigational Site Number 7100008
🇿🇦Umhlanga Rocks Suburb, South Africa
Investigational Site Number 7240006
🇪🇸Majadahonda, Spain
Investigational Site Number 7240010
🇪🇸Madrid, Spain
Investigational Site Number 7240007
🇪🇸Granada, Spain
Investigational Site Number 7240009
🇪🇸Barcelona, Spain
Investigational Site Number 7240011
🇪🇸Málaga, Spain
Investigational Site Number 7240004
🇪🇸Valencia, Spain
Investigational Site Number 7240014
🇪🇸Valencia, Spain
Investigational Site Number 7520003
🇸🇪Helsingborg, Sweden
Investigational Site Number 7520006
🇸🇪Goteborg, Sweden
Investigational Site Number 7520002
🇸🇪Malmö, Sweden
Investigational Site Number 7520001
🇸🇪Stockholm, Sweden
Investigational Site Number 7920012
🇹🇷Antalya, Turkey
Investigational Site Number 7920005
🇹🇷Adana, Turkey
Investigational Site Number 7920013
🇹🇷Eskisehir, Turkey
Investigational Site Number 7920010
🇹🇷Ankara, Turkey
Investigational Site Number 7920002
🇹🇷Bursa, Turkey
Investigational Site Number 7920015
🇹🇷Aydin, Turkey
Investigational Site Number 7920006
🇹🇷Istanbul, Turkey
Investigational Site Number 7920001
🇹🇷Istanbul, Turkey
Investigational Site Number 7920011
🇹🇷Izmit, Turkey
Investigational Site Number 7920014
🇹🇷Kutahya, Turkey
Investigational Site Number 7920007
🇹🇷Samsun, Turkey
Investigational Site Number 7920009
🇹🇷Sivas, Turkey
Investigational Site Number 8040001
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 8040004
🇺🇦Ternopil, Ukraine
Investigational Site Number 8400025
🇺🇸Sacramento, California, United States
Investigational Site Number 1520007
🇨🇱Santiago, Chile
Investigational Site Number 1520011
🇨🇱Santiago, Chile
Investigational Site Number 1520004
🇨🇱Viña Del Mar, Chile
Investigational Site Number 2330001
🇪🇪Tallinn, Estonia
Investigational Site Number 2460003
🇫🇮Kuopio, Finland
Investigational Site Number 3560009
🇮🇳New Delhi, India
Investigational Site Number 1520008
🇨🇱Concepción, Chile
Investigational Site Number 1520013
🇨🇱Santiago, Chile
Investigational Site Number 1520001
🇨🇱Santiago, Chile
Investigational Site Number 4840004
🇲🇽Actopan, Mexico
Investigational Site Number 6160007
🇵🇱Torun, Poland
Investigational Site Number 6420007
🇷🇴Bacau, Romania
Investigational Site Number 8400013
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8400018
🇺🇸Bronx, New York, United States
Investigational Site Number 8400088
🇺🇸El Paso, Texas, United States
Investigational Site Number 8400092
🇺🇸Richmond, Texas, United States
Investigational Site Number 8400015
🇺🇸Greer, South Carolina, United States
Investigational Site Number 8400067
🇺🇸Beaver, Pennsylvania, United States