An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes
NCT ID: NCT01400971
Last Updated: 2020-03-09
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
4299 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-07-31
Study Completion Date
2015-09-30
Brief Summary
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The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Study Groups
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MOSAIc Participants
Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with type 2 diabetes
* Have presented within the normal course of care
* Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
* Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
* Have been fully informed and have given written consent for the use of their data
* Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
* Have not initiated basal bolus therapy (three mealtime insulin injections)
* Have presented within the normal course of care
* Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
* Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
* Have been fully informed and have given written consent for the use of their data
* Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
* Have not initiated basal bolus therapy (three mealtime insulin injections)
Exclusion Criteria
* None
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Little Rock, Arkansas, United States
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Wellington, Florida, United States
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Canton, Georgia, United States
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Crystal Lake, Illinois, United States
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North Platte, Nebraska, United States
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Reno, Nevada, United States
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Burlington, North Carolina, United States
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Greensboro, North Carolina, United States
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Levittown, Pennsylvania, United States
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Charleston, South Carolina, United States
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Kingsport, Tennessee, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Alexandria, Virginia, United States
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Richmond, Virginia, United States
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Buenos Aires, , Argentina
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Corrientes, , Argentina
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Mendoza, , Argentina
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Paraná, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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Campina Grande do Sul, , Brazil
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Caxias do Sul, , Brazil
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Fortaleza, , Brazil
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Santa Maria, , Brazil
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São Paulo, , Brazil
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Setor Oeste/Goiania, , Brazil
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Tatuí, , Brazil
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Edmonton, Alberta, Canada
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Spruce Grove, Alberta, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Burlington, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Gatineau, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, , China
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Changchun, , China
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Chongqing, , China
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Guangzhou, , China
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Shijiazhuang, , China
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Xi'an, , China
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Bosenheim, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Hohenmölsen, , Germany
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Kamp-Lintfort, , Germany
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Lambrecht, , Germany
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Schramberg, , Germany
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Speyer, , Germany
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Ahmedabad, , India
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Ahmedabad, Gujarat, , India
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Bangalore, , India
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Belagavi, , India
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Hyderabaad, , India
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Jaipur, , India
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Kormangala, , India
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Mangalore, , India
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Mumbai, , India
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Mysore, , India
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Nagpur, , India
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New Delhi, , India
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Pune, , India
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Beer Yaakov, , Israel
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Beersheba, , Israel
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Dimona, , Israel
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Giv‘atayim, , Israel
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Netanya, , Israel
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Petah Tikva, , Israel
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Rishon LeZiyyon, , Israel
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Safed, , Israel
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Acquaviva delle Fonti, , Italy
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Ancona, , Italy
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Foggia, , Italy
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Lucca, , Italy
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Napoli, , Italy
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Parma, , Italy
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Pavia, , Italy
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Rome, , Italy
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San Giovanni Rotondo, , Italy
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Siena, , Italy
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Kanagawa, , Japan
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Kanagawa-Ken, , Japan
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Aguascalientes, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Huixquilucan, , Mexico
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Mexico City, , Mexico
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Zapopan, , Mexico
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Bayamón, , Puerto Rico
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Carolina, , Puerto Rico
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Loíza, , Puerto Rico
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Rio Piedras, , Puerto Rico
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Río Grande, , Puerto Rico
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San Juan, , Puerto Rico
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Toa Baja, , Puerto Rico
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Villa Fontana, , Puerto Rico
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Vsevolozhsk, , Russia
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Yaroslavl, , Russia
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Dammam, , Saudi Arabia
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Mecca, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Ta'if, , Saudi Arabia
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Daegu, , South Korea
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Daejeon, , South Korea
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Gangwon-Do, , South Korea
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Goyang-si, , South Korea
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Jeju Special Self-Governing Pr, , South Korea
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Sungnam-Si, , South Korea
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Barcelona, , Spain
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Gerena, , Spain
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La Roca del Vallès, , Spain
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Madrid, , Spain
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Seville, , Spain
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Vic, , Spain
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Ankara, , Turkey (Türkiye)
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Çanakkale, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Kırıkkale, , Turkey (Türkiye)
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Abu Dhabi, , United Arab Emirates
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Al Ain City, , United Arab Emirates
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Dubai, , United Arab Emirates
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Sharjah city, , United Arab Emirates
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Bath, Avon, United Kingdom
Site Status
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Torpoint, Cornwall, United Kingdom
Site Status
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Manchester, Greater Manchester, United Kingdom
Site Status
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Bolton, Lancashire, United Kingdom
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Doncaster, South Yorkshire, United Kingdom
Site Status
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Atherstone, Warwickshire, United Kingdom
Site Status
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Swansea, West Glamorgan, United Kingdom
Site Status
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Bradford-on-Avon, Wiltshire, United Kingdom
Site Status
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Cardiff, , United Kingdom
Site Status
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Chesterfield, , United Kingdom
Site Status
Countries
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United States
Argentina
Brazil
Canada
China
Germany
India
Israel
Italy
Japan
Mexico
Puerto Rico
Russia
Saudi Arabia
South Korea
Spain
Turkey (Türkiye)
United Arab Emirates
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
Reference Type
DERIVED
Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
Reference Type
DERIVED
Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
Reference Type
DERIVED
Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.
Reference Type
DERIVED
Other Identifiers
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F3Z-MC-B010
Identifier Type: OTHER
Identifier Source: secondary_id
14056
Identifier Type: -
Identifier Source: org_study_id
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