DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

NCT ID: NCT02226822

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1869 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-20

Study Completion Date

2019-02-12

Brief Summary

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This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.

Detailed Description

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This study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of T2DM who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. The follow-up period is 3 years. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with documented T2DM

Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Written consent obtained
2. Aged \> = 20 years
3. Diagnosed with type 2 diabetes mellitus
4. Initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class

Exclusion Criteria

1. Diagnosis of Type 1 Diabetes Mellitus
2. Current pregnancy
3. Current treatment for any cancer
4. Current dialysis treatment or renal transplantation
5. Current treatment with any oral steroids
6. Participation in any randomized control trials
7. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiyoshi Hashigami, M.D.

Role: STUDY_DIRECTOR

AstraZeneca

Iichiro Shimomura, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Metabolic Medicine (Internal Medicine), Graduate School of Medicine, Osaka University

Hirotaka Watada, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Metabolism & Endocrinology, Graduate School of Medicine, Juntendo University

Locations

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Research Site

Anjo, Aichi-ken, Japan

Site Status

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Anzai, Aichi-ken, Japan

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Komatsu, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Funabashi, Chiba, Japan

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Kisarazu, Chiba, Japan

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Tateyama, Chiba, Japan

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Matsuyama, Ehime, Japan

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Ono, Fukui, Japan

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Itoshima, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurate-gun, Fukuoka, Japan

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Oguri, Fukuoka, Japan

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Ōnojō, Fukuoka, Japan

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Iwaki, Fukushima, Japan

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Shirakawa, Fukushima, Japan

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Isesaki, Gunma, Japan

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Kanra-gun, Gunma, Japan

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Shibukawa, Gunma, Japan

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Takasaki, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Kamikawa, Hokkaido, Japan

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Muroran, Hokkaido, Japan

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Nakagawa, Hokkaido, Japan

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Otaru, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Tamba, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Koga, Ibaraki, Japan

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Ushiku, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Komatsu, Ishikawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Kanoya, Kagoshima-ken, Japan

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Chigasaki, Kanagawa, Japan

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Hiratsuka, Kanagawa, Japan

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Isehara, Kanagawa, Japan

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Kamakura, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Hitoyoshi, Kumamoto, Japan

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Tamana, Kumamoto, Japan

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Ise, Mie-ken, Japan

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Tsu, Mie-ken, Japan

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Yokkaichi, Mie-ken, Japan

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Sendai, Miyagi, Japan

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Nichinan, Miyazaki, Japan

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Iida, Nagano, Japan

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Ueda, Nagano, Japan

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Kitakatsuragi-gun, Nara, Japan

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Jōetsu, Niigata, Japan

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Tomigusuku, Okinawa, Japan

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Urazoe, Okinawa, Japan

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Ikuno-ku, Osaka, Japan

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Kashihara, Osaka, Japan

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Sennan-gun, Osaka, Japan

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Toyonaka, Osaka, Japan

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Imari, Saga-ken, Japan

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Karatsu, Saga-ken, Japan

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Nishimatuura, Saga-ken, Japan

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Kasukabe, Saitama, Japan

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Sakado, Saitama, Japan

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Kouka, Shiga, Japan

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Kōka, Shiga, Japan

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Maibara, Shiga, Japan

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Ōtsu, Shiga, Japan

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Hamamatsu, Shizuoka, Japan

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Yaizu, Shizuoka, Japan

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Nasushiobara, Tochigi, Japan

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Oyama, Tochigi, Japan

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Shimotsuga-gun, Tochigi, Japan

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Edogawa-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Kita-ku, Tokyo, Japan

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Koganei, Tokyo, Japan

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Kokubunji, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Iwade, Wakayama, Japan

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Nakami, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Kofu, Yamanashi, Japan

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Chiba, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Hiroshima, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Miyazaki, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saga, , Japan

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Shizuoka, , Japan

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Tochigi, , Japan

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Tokushima, , Japan

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Yamagata, , Japan

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Countries

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Japan

References

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Al Rubeaan K, Banah F, Alruwaily FG, Sheshah E, Alnaqeb D, AlQahtani AM, Ewais D, Al Juhani N, Hassan AH, Youssef AM. Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme. BMJ Open. 2023 Aug 30;13(8):e063586. doi: 10.1136/bmjopen-2022-063586.

Reference Type DERIVED
PMID: 37648382 (View on PubMed)

Mita T, Katakami N, Takahara M, Kawashima M, Wada F, Akiyama H, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H. Changes in Treatment Satisfaction Over 3 Years in Patients With Type 2 Diabetes After Initiating Second-line Treatment. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2424-2432. doi: 10.1210/clinem/dgac420.

Reference Type DERIVED
PMID: 35857060 (View on PubMed)

Hejjaji V, Gorgojo-Martinez JJ, Tang F, Garnelo JB, Cooper A, Medina J, Mutiozabal MS, Khunti K, Nicolucci A, Shestakova MV, Ji L, Gomes MB, Watada H, Vora J, Malik AO, Kosiborod M, Arnold SV. Factors associated with weight loss in people with overweight or obesity living with type 2 diabetes mellitus: Insights from the global DISCOVER study. Diabetes Obes Metab. 2022 Sep;24(9):1734-1740. doi: 10.1111/dom.14745. Epub 2022 May 25.

Reference Type DERIVED
PMID: 35546275 (View on PubMed)

Takahara M, Mita T, Katakami N, Wada F, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H; J-DISCOVER study group. Three-Year Glycaemic Control and Management in Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: A Prospective Observational Study, J-DISCOVER. Diabetes Ther. 2022 Feb;13(2):251-264. doi: 10.1007/s13300-021-01192-x. Epub 2021 Dec 28.

Reference Type DERIVED
PMID: 34962628 (View on PubMed)

Khunti K, Gomes MB, Kosiborod M, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Tang F, Ji L; DISCOVER Scientific Committee and all DISCOVER investigators. Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme. BMJ Open. 2020 Aug 30;10(8):e034613. doi: 10.1136/bmjopen-2019-034613.

Reference Type DERIVED
PMID: 32868349 (View on PubMed)

Katakami N, Mita T, Takahara M, Yajima T, Wada F, Kawashima M, Shimomura I, Watada H; J-DISCOVER Study Group. Baseline Characteristics of Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: Findings from the J-DISCOVER Study. Diabetes Ther. 2020 Jul;11(7):1563-1578. doi: 10.1007/s13300-020-00846-6. Epub 2020 Jun 5.

Reference Type DERIVED
PMID: 32504219 (View on PubMed)

Khunti K, Chen H, Cid-Ruzafa J, Fenici P, Gomes MB, Hammar N, Ji L, Kosiborod M, Pocock S, Shestakova MV, Shimomura I, Tang F, Watada H, Nicolucci A; DISCOVER investigators. Glycaemic control in patients with type 2 diabetes initiating second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2020 Jan;22(1):66-78. doi: 10.1111/dom.13866. Epub 2019 Oct 1.

Reference Type DERIVED
PMID: 31468637 (View on PubMed)

Nicolucci A, Charbonnel B, Gomes MB, Khunti K, Kosiborod M, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Pocock S. Treatment patterns and associated factors in 14 668 people with type 2 diabetes initiating a second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2474-2485. doi: 10.1111/dom.13830. Epub 2019 Aug 5.

Reference Type DERIVED
PMID: 31297947 (View on PubMed)

Khunti K, Ji L, Medina J, Surmont F, Kosiborod M. Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2349-2353. doi: 10.1111/dom.13817. Epub 2019 Jul 14.

Reference Type DERIVED
PMID: 31215715 (View on PubMed)

Kosiborod M, Gomes MB, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Watada H, Shimomura I, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Khunti K; DISCOVER investigators. Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program). Cardiovasc Diabetol. 2018 Nov 28;17(1):150. doi: 10.1186/s12933-018-0787-8.

Reference Type DERIVED
PMID: 30486889 (View on PubMed)

Katakami N, Mita T, Takahara M, Hashigami K, Kawashima M, Shimomura I, Watada H; J-DISCOVER study group. Rationale and Design for the J-DISCOVER Study: DISCOVERing the Treatment Reality of Type 2 Diabetes in a Real-World Setting in Japan-A Protocol. Diabetes Ther. 2018 Feb;9(1):165-175. doi: 10.1007/s13300-017-0351-7. Epub 2017 Dec 19.

Reference Type DERIVED
PMID: 29260460 (View on PubMed)

Other Identifiers

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D1692R00001

Identifier Type: -

Identifier Source: org_study_id

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