ClinicalTrials.gov record
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
ClinicalTrials.gov ID: NCT01959529
Public ClinicalTrials.gov record NCT01959529. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Study identification
- NCT ID
- NCT01959529
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novo Nordisk A/S
- Industry
- Enrollment
- 7,637 participants
Conditions and interventions
Conditions
Interventions
- insulin degludec Drug
- insulin glargine Drug
Drug
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2013
- Primary completion
- Oct 15, 2016
- Completion
- Oct 15, 2016
- Last update posted
- Jul 23, 2019
2013 – 2016
United States locations
- U.S. sites
- 267
- U.S. states
- 42
- U.S. cities
- 212
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35216 | — |
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35294 | — |
| Novo Nordisk Investigational Site | Montgomery | Alabama | 36106 | — |
| Novo Nordisk Investigational Site | Montgomery | Alabama | 36109 | — |
| Novo Nordisk Investigational Site | Gilbert | Arizona | 85295 | — |
| Novo Nordisk Investigational Site | Glendale | Arizona | 85308 | — |
| Novo Nordisk Investigational Site | Litchfield Park | Arizona | 85340 | — |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85050 | — |
| Novo Nordisk Investigational Site | Tucson | Arizona | 85704 | — |
| Novo Nordisk Investigational Site | Tucson | Arizona | 85714 | — |
| Novo Nordisk Investigational Site | Tucson | Arizona | 85723 | — |
| Novo Nordisk Investigational Site | Little Rock | Arkansas | 72205-5446 | — |
| Novo Nordisk Investigational Site | Little Rock | Arkansas | 72205 | — |
| Novo Nordisk Investigational Site | Searcy | Arkansas | 72143 | — |
| Novo Nordisk Investigational Site | Chula Vista | California | 91910 | — |
| Novo Nordisk Investigational Site | Concord | California | 94520 | — |
| Novo Nordisk Investigational Site | Downey | California | 90242 | — |
| Novo Nordisk Investigational Site | Duarte | California | 91010 | — |
| Novo Nordisk Investigational Site | Encino | California | 91436 | — |
| Novo Nordisk Investigational Site | Fresno | California | 93720 | — |
| Novo Nordisk Investigational Site | Greenbrae | California | 94904 | — |
| Novo Nordisk Investigational Site | Huntington Beach | California | 92648 | — |
| Novo Nordisk Investigational Site | Inglewood | California | 90301 | — |
| Novo Nordisk Investigational Site | La Jolla | California | 92037 | — |
| Novo Nordisk Investigational Site | La Mesa | California | 91942 | — |
| Novo Nordisk Investigational Site | Lancaster | California | 93534 | — |
| Novo Nordisk Investigational Site | Long Beach | California | 90822 | — |
| Novo Nordisk Investigational Site | Los Alamitos | California | 90720 | — |
| Novo Nordisk Investigational Site | Mission Hills | California | 91345 | — |
| Novo Nordisk Investigational Site | Montclair | California | 91763 | — |
| Novo Nordisk Investigational Site | Monterey | California | 93940 | — |
| Novo Nordisk Investigational Site | North Hollywood | California | 91606 | — |
| Novo Nordisk Investigational Site | Palm Springs | California | 92262 | — |
| Novo Nordisk Investigational Site | Poway | California | 92064 | — |
| Novo Nordisk Investigational Site | San Diego | California | 92111 | — |
| Novo Nordisk Investigational Site | San Diego | California | 92120 | — |
| Novo Nordisk Investigational Site | San Ramon | California | 94583 | — |
| Novo Nordisk Investigational Site | Santa Ana | California | 92704 | — |
| Novo Nordisk Investigational Site | Sherman Oaks | California | 91403 | — |
| Novo Nordisk Investigational Site | Thousand Oaks | California | 91360 | — |
| Novo Nordisk Investigational Site | Tustin | California | 92780 | — |
| Novo Nordisk Investigational Site | Ventura | California | 93003 | — |
| Novo Nordisk Investigational Site | Vista | California | 92083 | — |
| Novo Nordisk Investigational Site | Westminster | California | 92683 | — |
| Novo Nordisk Investigational Site | Colorado Springs | Colorado | 80909 | — |
| Novo Nordisk Investigational Site | Denver | Colorado | 80220 | — |
| Novo Nordisk Investigational Site | Denver | Colorado | 80246 | — |
| Novo Nordisk Investigational Site | Golden | Colorado | 80401 | — |
| Novo Nordisk Investigational Site | Danbury | Connecticut | 06810 | — |
| Novo Nordisk Investigational Site | Norwalk | Connecticut | 06851 | — |
| Novo Nordisk Investigational Site | Waterbury | Connecticut | 06708 | — |
| Novo Nordisk Investigational Site | Boca Raton | Florida | 33433 | — |
| Novo Nordisk Investigational Site | Boynton Beach | Florida | 33472 | — |
| Novo Nordisk Investigational Site | Bradenton | Florida | 34201 | — |
| Novo Nordisk Investigational Site | Brandon | Florida | 33511 | — |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33756 | — |
| Novo Nordisk Investigational Site | Cooper City | Florida | 33024 | — |
| Novo Nordisk Investigational Site | Fleming Island | Florida | 32003 | — |
| Novo Nordisk Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| Novo Nordisk Investigational Site | Gainesville | Florida | 32610 | — |
| Novo Nordisk Investigational Site | Green Cove Springs | Florida | 32043 | — |
| Novo Nordisk Investigational Site | Hialeah | Florida | 33012 | — |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32207 | — |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32216 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33135 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33155 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33165 | — |
| Novo Nordisk Investigational Site | Miami | Florida | 33183 | — |
| Novo Nordisk Investigational Site | Naples | Florida | 34119 | — |
| Novo Nordisk Investigational Site | New Port Richey | Florida | 34652 | — |
| Novo Nordisk Investigational Site | Orlando | Florida | 32806 | — |
| Novo Nordisk Investigational Site | Panama City | Florida | 32401 | — |
| Novo Nordisk Investigational Site | Ponte Vedra | Florida | 32081 | — |
| Novo Nordisk Investigational Site | Port Charlotte | Florida | 33952 | — |
| Novo Nordisk Investigational Site | Port Orange | Florida | 32127 | — |
| Novo Nordisk Investigational Site | South Miami | Florida | 33143 | — |
| Novo Nordisk Investigational Site | Tampa | Florida | 33619 | — |
| Novo Nordisk Investigational Site | Tampa | Florida | 33624 | — |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30339 | — |
| Novo Nordisk Investigational Site | Decatur | Georgia | 30033 | — |
| Novo Nordisk Investigational Site | Dunwoody | Georgia | 30338 | — |
| Novo Nordisk Investigational Site | Lawrenceville | Georgia | 30046 | — |
| Novo Nordisk Investigational Site | Roswell | Georgia | 30076 | — |
| Novo Nordisk Investigational Site | Savannah | Georgia | 31406 | — |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | — |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | — |
| Novo Nordisk Investigational Site | Addison | Illinois | 60101 | — |
| Novo Nordisk Investigational Site | Champaign | Illinois | 61821 | — |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | — |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60616 | — |
| Novo Nordisk Investigational Site | Crystal Lake | Illinois | 60012 | — |
| Novo Nordisk Investigational Site | Gurnee | Illinois | 60031 | — |
| Novo Nordisk Investigational Site | Hines | Illinois | 60141 | — |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62702 | — |
| Novo Nordisk Investigational Site | Springfield | Illinois | 62711 | — |
| Novo Nordisk Investigational Site | Brownsburg | Indiana | 46112 | — |
| Novo Nordisk Investigational Site | Evansville | Indiana | 47714 | — |
| Novo Nordisk Investigational Site | Franklin | Indiana | 46131 | — |
| Novo Nordisk Investigational Site | Greenfield | Indiana | 46140 | — |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46254 | — |
| Novo Nordisk Investigational Site | Michigan City | Indiana | 46360 | — |
| Novo Nordisk Investigational Site | Muncie | Indiana | 47304 | — |
| Novo Nordisk Investigational Site | Council Bluffs | Iowa | 51501 | — |
| Novo Nordisk Investigational Site | Wichita | Kansas | 67205 | — |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40502 | — |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | — |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40206 | — |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40213 | — |
| Novo Nordisk Investigational Site | Madisonville | Kentucky | 42431 | — |
| Novo Nordisk Investigational Site | Monroe | Louisiana | 71203 | — |
| Novo Nordisk Investigational Site | New Orleans | Louisiana | 70119 | — |
| Novo Nordisk Investigational Site | Shreveport | Louisiana | 71103 | — |
| Novo Nordisk Investigational Site | Slidell | Louisiana | 70461-4231 | — |
| Novo Nordisk Investigational Site | Bangor | Maine | 04401 | — |
| Novo Nordisk Investigational Site | Hyattsville | Maryland | 20782 | — |
| Novo Nordisk Investigational Site | Rockville | Maryland | 20852 | — |
| Novo Nordisk Investigational Site | Watertown | Massachusetts | 02472 | — |
| Novo Nordisk Investigational Site | Worcester | Massachusetts | 01655 | — |
| Novo Nordisk Investigational Site | Ann Arbor | Michigan | 48105 | — |
| Novo Nordisk Investigational Site | Ann Arbor | Michigan | 48106 | — |
| Novo Nordisk Investigational Site | Buckley | Michigan | 49620 | — |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | — |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48202 | — |
| Novo Nordisk Investigational Site | Kalamazoo | Michigan | 49009 | — |
| Novo Nordisk Investigational Site | Livonia | Michigan | 48152 | — |
| Novo Nordisk Investigational Site | Troy | Michigan | 48098 | — |
| Novo Nordisk Investigational Site | Olive Branch | Mississippi | 38654 | — |
| Novo Nordisk Investigational Site | Hazelwood | Missouri | 63042 | — |
| Novo Nordisk Investigational Site | Jefferson City | Missouri | 65109 | — |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64111 | — |
| Novo Nordisk Investigational Site | Billings | Montana | 59101 | — |
| Novo Nordisk Investigational Site | Kalispell | Montana | 59901 | — |
| Novo Nordisk Investigational Site | Elkhorn | Nebraska | 68022 | — |
| Novo Nordisk Investigational Site | Fremont | Nebraska | 68025 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68105 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68114 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68124 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68144 | — |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68198-4120 | — |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89120 | — |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89128 | — |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89148 | — |
| Novo Nordisk Investigational Site | Nashua | New Hampshire | 03063 | — |
| Novo Nordisk Investigational Site | East Brunswick | New Jersey | 08816 | — |
| Novo Nordisk Investigational Site | Hoboken | New Jersey | 07030 | — |
| Novo Nordisk Investigational Site | Albany | New York | 12206 | — |
| Novo Nordisk Investigational Site | Lake Success | New York | 11042 | — |
| Novo Nordisk Investigational Site | Mineola | New York | 11501 | — |
| Novo Nordisk Investigational Site | New Windsor | New York | 12553 | — |
| Novo Nordisk Investigational Site | New York | New York | 10029 | — |
| Novo Nordisk Investigational Site | North Massapequa | New York | 11758-1802 | — |
| Novo Nordisk Investigational Site | Northport | New York | 11768 | — |
| Novo Nordisk Investigational Site | Rochester | New York | 14607 | — |
| Novo Nordisk Investigational Site | West Seneca | New York | 14224 | — |
| Novo Nordisk Investigational Site | Westfield | New York | 14787 | — |
| Novo Nordisk Investigational Site | Asheville | North Carolina | 28801 | — |
| Novo Nordisk Investigational Site | Asheville | North Carolina | 28803 | — |
| Novo Nordisk Investigational Site | Burlington | North Carolina | 27215 | — |
| Novo Nordisk Investigational Site | Cary | North Carolina | 27518 | — |
| Novo Nordisk Investigational Site | Chapel Hill | North Carolina | 27517 | — |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28209 | — |
| Novo Nordisk Investigational Site | Greenville | North Carolina | 27834 | — |
| Novo Nordisk Investigational Site | Lexington | North Carolina | 27292 | — |
| Novo Nordisk Investigational Site | Morehead City | North Carolina | 28557 | — |
| Novo Nordisk Investigational Site | New Bern | North Carolina | 28562 | — |
| Novo Nordisk Investigational Site | Statesville | North Carolina | 28625 | — |
| Novo Nordisk Investigational Site | Whiteville | North Carolina | 28472 | — |
| Novo Nordisk Investigational Site | Wilmington | North Carolina | 28401 | — |
| Novo Nordisk Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Novo Nordisk Investigational Site | Fargo | North Dakota | 58104 | — |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45236 | — |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44106-1702 | — |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44121 | — |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44195 | — |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43235 | — |
| Novo Nordisk Investigational Site | Delaware | Ohio | 43015 | — |
| Novo Nordisk Investigational Site | Franklin | Ohio | 45005 | — |
| Novo Nordisk Investigational Site | Maumee | Ohio | 43537 | — |
| Novo Nordisk Investigational Site | Mentor | Ohio | 44060 | — |
| Novo Nordisk Investigational Site | Perrysburg | Ohio | 43551 | — |
| Novo Nordisk Investigational Site | Norman | Oklahoma | 73069 | — |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239-3098 | — |
| Novo Nordisk Investigational Site | Altoona | Pennsylvania | 16602 | — |
| Novo Nordisk Investigational Site | Beaver | Pennsylvania | 15009 | — |
| Novo Nordisk Investigational Site | Danville | Pennsylvania | 17822 | — |
| Novo Nordisk Investigational Site | Hermitage | Pennsylvania | 16148 | — |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19114 | — |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15243 | — |
| Novo Nordisk Investigational Site | Smithfield | Pennsylvania | 15478 | — |
| Novo Nordisk Investigational Site | Uniontown | Pennsylvania | 15401 | — |
| Novo Nordisk Investigational Site | Upper Darby | Pennsylvania | 19082 | — |
| Novo Nordisk Investigational Site | Wilkes-Barre | Pennsylvania | 18702 | — |
| Novo Nordisk Investigational Site | Anderson | South Carolina | 29621 | — |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | — |
| Novo Nordisk Investigational Site | Moncks Corner | South Carolina | 29461 | — |
| Novo Nordisk Investigational Site | Murrells Inlet | South Carolina | 29576 | — |
| Novo Nordisk Investigational Site | Myrtle Beach | South Carolina | 29572 | — |
| Novo Nordisk Investigational Site | Orangeburg | South Carolina | 29118 | — |
| Novo Nordisk Investigational Site | Spartanburg | South Carolina | 29303 | — |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404-1192 | — |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | — |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37411 | — |
| Novo Nordisk Investigational Site | Kingsport | Tennessee | 37660 | — |
| Novo Nordisk Investigational Site | Knoxville | Tennessee | 37938 | — |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38119 | — |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38163 | — |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37203 | — |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37208 | — |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37212 | — |
| Novo Nordisk Investigational Site | Tullahoma | Tennessee | 37388 | — |
| Novo Nordisk Investigational Site | Arlington | Texas | 76012 | — |
| Novo Nordisk Investigational Site | Austin | Texas | 78705 | — |
| Novo Nordisk Investigational Site | Austin | Texas | 78731 | — |
| Novo Nordisk Investigational Site | Austin | Texas | 78749 | — |
| Novo Nordisk Investigational Site | Carrollton | Texas | 75007 | — |
| Novo Nordisk Investigational Site | Carrollton | Texas | 75010 | — |
| Novo Nordisk Investigational Site | Corpus Christi | Texas | 78404 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75231 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | — |
| Novo Nordisk Investigational Site | Dallas | Texas | 75390-9302 | — |
| Novo Nordisk Investigational Site | Fort Worth | Texas | 76117 | — |
| Novo Nordisk Investigational Site | Fort Worth | Texas | 76132 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77008 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77024 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77029 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77060 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77061 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77070 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77093 | — |
| Novo Nordisk Investigational Site | Houston | Texas | 77099 | — |
| Novo Nordisk Investigational Site | Humble | Texas | 77338 | — |
| Novo Nordisk Investigational Site | Hurst | Texas | 76054 | — |
| Novo Nordisk Investigational Site | Irving | Texas | 75039 | — |
| Novo Nordisk Investigational Site | Lewisville | Texas | 75067 | — |
| Novo Nordisk Investigational Site | Longview | Texas | 75605 | — |
| Novo Nordisk Investigational Site | Lubbock | Texas | 79423 | — |
| Novo Nordisk Investigational Site | Midland | Texas | 79707 | — |
| Novo Nordisk Investigational Site | Odessa | Texas | 79761 | — |
| Novo Nordisk Investigational Site | Pearland | Texas | 77584 | — |
| Novo Nordisk Investigational Site | Richardson | Texas | 75080 | — |
| Novo Nordisk Investigational Site | Round Rock | Texas | 78681 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78215 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78228-6205 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | — |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78258 | — |
| Novo Nordisk Investigational Site | Splendora | Texas | 77372 | — |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77478 | — |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77479 | — |
| Novo Nordisk Investigational Site | Waco | Texas | 76710 | — |
| Novo Nordisk Investigational Site | Salt Lake City | Utah | 84102 | — |
| Novo Nordisk Investigational Site | Salt Lake City | Utah | 84132 | — |
| Novo Nordisk Investigational Site | Bennington | Vermont | 05201 | — |
| Novo Nordisk Investigational Site | South Burlington | Vermont | 05403 | — |
| Novo Nordisk Investigational Site | Midlothian | Virginia | 23114 | — |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23510 | — |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23249 | — |
| Novo Nordisk Investigational Site | Winchester | Virginia | 22601-3834 | — |
| Novo Nordisk Investigational Site | Richland | Washington | 99352 | — |
| Novo Nordisk Investigational Site | Spokane | Washington | 99201 | — |
| Novo Nordisk Investigational Site | Kenosha | Wisconsin | 53144 | — |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53209 | — |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53295 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 179 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01959529, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2019 · Synced May 13, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01959529 live on ClinicalTrials.gov.