DIA_CENTRAL:T2D Treatment Pattern in Central Europe

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03807440
Collaborator
(none)
3,735
177
24.2
21.1
0.9

Study Details

Study Description

Brief Summary

This is a non-interventional study using existing data including medical chart review.

Condition or Disease Intervention/Treatment Phase
  • Drug: Empagliflozin
  • Drug: Sodium Glucose Transporter 2 inhibitor
  • Drug: Dipeptidyl-peptidase 4 inhibitor
  • Drug: Glucagon-like peptide 1 agonist

Study Design

Study Type:
Observational
Actual Enrollment :
3735 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
CORDIALLY® - CEE: Characteristics of Patients With Type 2 Diabetes Treated With Modern Antidiabetic Drugs. A Real World Data Collection of Patient Baseline Characteristics, Treatment Patterns and Comorbidities in Central Eastern European (CEE) Countries
Actual Study Start Date :
Aug 26, 2019
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Subjects with Diabetes Mellitus, Type 2

Drug: Empagliflozin
Empagliflozin
Other Names:
  • Jardiance® Synjardy® Trajenta® Jentadueto®
  • Drug: Sodium Glucose Transporter 2 inhibitor
    Sodium Glucose Transporter 2 inhibitor
    Other Names:
  • Jardiance® Synjardy® Trajenta® Jentadueto®
  • Drug: Dipeptidyl-peptidase 4 inhibitor
    Dipeptidyl-peptidase 4 inhibitor
    Other Names:
  • Jardiance® Synjardy® Trajenta® Jentadueto®
  • Drug: Glucagon-like peptide 1 agonist
    Glucagon-like peptide 1 agonist
    Other Names:
  • Jardiance® Synjardy® Trajenta® Jentadueto®
  • Outcome Measures

    Primary Outcome Measures

    1. T2D patients' baseline characteristics when initiating either empagliflozin - or other SGLT2i, DPP4i or GLP1a on top of current antidiabetic treatment by different HCP specialties in CEE countries [at baseline]

    Secondary Outcome Measures

    1. Burden of comorbidities (prevalence of cardiovascular disease (CVD), chronic kidney disease (CKD) and CVD/CKD risk factors) in this T2D patient population [up to 4 months]

    2. Actual treatment use in patients with and without established CVD [up to 4 months]

      Established CV disease defined as acute myocardial infarction (AMI), cardiology intervention, ischemic heart disease (IHD), congestive heart failure (CHF), peripheral arterial disease (PAD), or stroke

    3. Association of socioeconomic parameters with treatment decisions [up to 4 months]

    4. Discontinuation rate for GLP1a, DPP4i and SGLT2i after a follow up of approximately one year from the initial time point [up to 14 months]

    5. Reasons for discontinuation for GLP1a, DPP4i and SGLT2i after a follow up of approximately one year from the initial time point [up to 14 months]

    6. Average duration of treatment for GLP1a, DPP4i and SGLT2i after a follow up of approximately one year from the initial time point [up to 14 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Written informed consent prior to participation

    2. Female and male patients age ≥ 18 years

    3. Patients with T2D diagnosis

    4. Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)

    5. Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1

    Exclusion Criteria:
    1. Patients age < 18 years

    2. Patients with diagnosis of other types of diabetes than T2D

    3. Patients who do not provide written consent to the terms of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MHAT "Julia Verevska-Byala" EOOD, Center Nr.: 35903 Byala Bulgaria 7100
    2 MC "Diamedical 2013" OOD, Center Nr.: 35902 Dimitrovgrad Bulgaria 6400
    3 MBAL- Dobrich AD, Center Nr.: 35916 Dobrich Bulgaria 9300
    4 Dr. T. K. Bacheva - ASMP-IP-E EOOD, Center Nr.: 35904 Dupnitsa Bulgaria 2600
    5 MHAT "Medline Clinic", Center Nr.: 35911 Plovdiv Bulgaria 4000
    6 MC Kuchuk Parij OOD, Center Nr.: 35906 Plovdiv Bulgaria 4030
    7 MC Saint Elisaveta-Rakovski EOOD, Center Nr.: 35909 Rakovski Bulgaria 4150
    8 "Medical Center-Razgrad"OOD, Center Nr.: 35910 Razgrad Bulgaria 7200
    9 DCC 1 - Russe EOOD, Center Nr.: 35905 Russe Bulgaria 7000
    10 MBAL "Hadzhi Dimitar" OOD, Center Nr.: 35915 Sliven Bulgaria 8800
    11 MC Polimed AD, Center Nr.: 35907 Sofia Bulgaria 1303
    12 MC Gina - LZ SIMP EOOD, Center Nr.: 35918 Sofia Bulgaria 1463
    13 MC "Vitaclinic" EOOD, Center Nr.: 35901 Sofia Bulgaria 1680
    14 MC Kalimat EOOD, Center Nr.: 35914 Sofia Bulgaria 1680
    15 Acibadem City Clinic Medical Center Varna EOOD, Center Nr.: 35908 Varna Bulgaria 9002
    16 Michal Brada, Center Nr.: 42001 Beclav Czechia 69002
    17 Dr. Kovaová, Center Nr.: 42069 Beroun Czechia 26656
    18 Practice Dr. Alice Sýkorová, Center Nr.: 42057 Bilina Czechia 418 01
    19 MUDr. Alica Vesela, Center Nr.: 42030 Broumov Czechia 55001
    20 EUC Klinika eské Budjovice, Center Nr.: 42052 Eské Budjovice Czechia 37001
    21 Lékaský dm Géko, Center Nr.: 42059 Eské Budjovice Czechia 37011
    22 Barbara Buzová, Center Nr.: 42003 Havíov Czechia 73601
    23 Zaviatiová, Petra, Center Nr.: 42004 Havíov Czechia 73601
    24 Radana Syslová, Center Nr.: 42035 Hlušovice Czechia 78314
    25 Pavel Kasík, Center Nr.: 42046 Hoovice Czechia 268 31
    26 Practice Dr. Petr Maule, Center Nr.: 42054 Humpolec Czechia 39601
    27 Mediab Jihlava s.r.o., Center Nr.: 42066 Jihlava Czechia 58601
    28 Practice MUDr. Gita Markofová, Center Nr.: 42053 Karlovy Vary Czechia 36066
    29 Dr. Konená, Center Nr.: 42036 Karviná - Staré Msto Czechia 73301
    30 Practice Zdzislaw Wranka, Center Nr.: 42072 Karviná-Hranice Czechia 73301
    31 Pavel Tománek, Center Nr.: 42028 Kopivnice Czechia 74221
    32 DIABET HELP s.r.o., Center Nr.: 42058 Kralupy nad Vltavou Czechia 27801
    33 MUDr.Tomáš Edelsberger, Center Nr.: 42007 Krnov Czechia 79401
    34 Jitka Hasalová, Center Nr.: 42010 Kromiz Czechia 76901
    35 árka Drinková, Center Nr.: 42038 Lede Nad Sázavou Czechia 58401
    36 Martina Košková, Center Nr.: 42047 Mladá Boleslav Czechia 29350
    37 Dobromila Vykoupilová, Center Nr.: 42033 Nmice Nad Hanou Czechia 79827
    38 Karel Churavý, Center Nr.: 42005 Nový Jiín Czechia 74101
    39 árka Kubánková, Center Nr.: 42048 Nymburk Czechia 28802
    40 Agentura Science Pro spol. s.r.o., Center Nr.: 42002 Olomouc Czechia 772 00
    41 Anna Rancová, Center Nr.: 42025 Olomouc Czechia 77900
    42 Josef íný, Center Nr.: 42026 Opava Czechia 74601
    43 MUDr.Tomáš Hrdina, Center Nr.: 42015 Opono Czechia 51773
    44 Radka Nágelová, Center Nr.: 42020 Ostrava Poruba Czechia 70800
    45 Dr. Šeptáková, Center Nr.: 42074 Ostrava Czechia 700 30
    46 Practice Dr. René Turínek, Center Nr.: 42034 Ostrava Czechia 70200
    47 MUDr. Eva Raická, Center Nr.: 42024 Ostrava Czechia 71000
    48 Jitka Homolová, Center Nr.: 42012 Ostrava Czechia 72880
    49 AIDIN VK s.r.o., Center Nr.: 42017 Perov Czechia 75301
    50 Zdenk Jankovec, Center Nr.: 42044 Plze Czechia 30100
    51 Diabetologická a interní ambulance, Center Nr.: 42064 Podbrady Czechia 29001
    52 Practice Dr. Milena Peterková, Center Nr.: 42063 Praha 2 Czechia 12143
    53 MUDr.Michala Pelikánová s.r.o., Center Nr.: 42055 Praha 4 Czechia 14000
    54 Markéta Hovorková, Center Nr.: 42042 Praha 4 Czechia 14021
    55 Jakub Hron, Center Nr.: 42043 Praha 4 Czechia 14300
    56 Milan Fleka, Center Nr.: 42041 Praha 5 Czechia 15000
    57 Jií Jón, Center Nr.: 42045 Praha 5 Czechia 15030
    58 Practice Dr. Lucie Kufová, Center Nr.: 42062 Praha 5 Czechia 15030
    59 Practice Dr. Ida Reissová, Center Nr.: 42056 Praha 6 Czechia 16300
    60 Barbora Diepoltová, Center Nr.: 42037 Praha 9 Czechia 19014
    61 MUDr. Jana Houdová, Center Nr.: 42068 Praha Czechia 10000
    62 MUDr. Vra Prýmková, Center Nr.: 42070 Píbram Czechia 26101
    63 Practice Dr. Petronela Janeková, Center Nr.: 42065 Rumburk Czechia 40801
    64 Practice Dr. Miroslav Lindovský, Center Nr.: 42051 Sokolov Czechia 35601
    65 Dana Fialkoviová, Center Nr.: 42040 Strakonice Czechia 38601
    66 Marek Frydrych, Center Nr.: 42008 Tebí Czechia 674 01
    67 Marek Frydrych, Center Nr.: 42077 Tebí Czechia 674 01
    68 Diabetologická ambulance s.r.o., Center Nr.: 42076 Uherské Hradišt Czechia 68601
    69 Dr. Hrmová, Center Nr.: 42073 Vlašim Czechia 25801
    70 Lubomír Kudlej, Center Nr.: 42050 Vrchlabí Czechia 54301
    71 AdiaMed s.r.o., Center Nr.: 42009 Vsetín Czechia 75501
    72 EUC Klinika Zlín a.s., Center Nr.: 42075 Zlín Czechia 76001
    73 Robin Urbánek, Center Nr.: 42029 Zlín Czechia 76001
    74 Bajcsy-Zsilinszky Kórház és Rendelintézet, Center Nr.: 36019 Budapest Hungary 1106
    75 Jahn Ferenc Dél-pesti Kórház és Rendelintézet, Center Nr.: 36014 Budapest Hungary 1204
    76 Debreceni Egyetem Klinikai Központ, Kardiológiai Klinika, Center Nr.: 36006 Debrecen Hungary 4032
    77 Kátai Gábor Kórház, Diabetológia Szakrendelés, Center Nr.: 36007 Karcag Hungary 5300
    78 Practice Dr. Lelkesi Anita, Center Nr.: 36013 Mátészalka Hungary 4700
    79 Nagyatádi Kórház, Center Nr.: 36021 Nagyatád Hungary 7500
    80 Nyírségi Diabetes Centrum, Center Nr.: 36024 Nyíregyháza Hungary 4400
    81 Dr. Wagner Zoltán, Center Nr.: 36020 Pécs Hungary 7625
    82 Siófoki Kórház Rendelintézet, Center Nr.: 36004 Siófok Hungary 8600
    83 Soproni Gyógyközpont, Center Nr.: 36018 Sopron Hungary 9400
    84 Gabinet Diabetologiczno- Internistyczny Katarzyna Wasilewska, Center Nr.: 48011 Biaystok Poland 15-591
    85 NZOZ DIAMED Sp. z o.o., Center Nr.: 48061 Czechowice-Dziedzice Poland 43-502
    86 Prywatny Gabinet Lekarski dr n. med. Joanna Sawer-Szewczyk, Center Nr.: 48055 Czyca Poland 99-100
    87 Zespó Opieki Zdrowotnej w czycy, Center Nr.: 48054 Czyca Poland 99-100
    88 NZOZ Sal Med, Center Nr.: 48047 Dzieroniów Poland 58-200
    89 Poradnia Diabetologiczna, Center Nr.: 48028 Gorlice Poland 38-300
    90 Indywidualna Specjalistyczna Praktyka Lekarska Piotr Piskozub Specjalista Diabetolog, Center Nr.: 48042 Jelenia Góra Poland 58-506
    91 NZOZ Poradnia Diabetologiczna, Center Nr.: 48038 Konin Poland 62-504
    92 Zakad Opieki Medycznej Sanatio; Sp. Z. o.o., Center Nr.: 48030 Kraków Poland 31-548
    93 Prywatny Gabinet Lekarski Tomasz Wierzykowski, Center Nr.: 48053 Kutno Poland 99-300
    94 Indywidualna Specjalistyczna Praktyka Lekarska Magorzata Poskoska-Lemaska, Center Nr.: 48035 Kwidzyn Poland 82-500
    95 Indywidualna Specjalistyczna Praktyka Lekarska Barbara Soróbka, Center Nr.: 48001 Legnica Poland 59-220
    96 Poradnia Cukrzycowa SP ZOZ w Lesku, Center Nr.: 48024 Lesko Poland 38-600
    97 Lumed Sp. z o.o., Center Nr.: 48032 Lubaczów Poland 37-600
    98 DIABETA-CARE Sp.z o.o., Center Nr.: 48008 Lubin Poland 59-300
    99 Poradnia Diabetologiczna Dr. mudziska, Center Nr.: 48013 Nako Nad Noteci Poland 89-100
    100 Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Center Nr.: 48007 Nowy Scz Poland 33-300
    101 Poradnia Diabetologiczna Dr. Adamczyk-Gajda, Center Nr.: 48031 Olenica Poland 56-400
    102 MED-ART Sp. z o.o., Center Nr.: 48052 Orzesze Poland 43-180
    103 Indywidualna Specjalistyczna Praktyka Lekarska Wiesawa Fischer, Center Nr.: 48020 Ostrów Wielkopolski Poland 63-400
    104 Prywatny Gabinet Lekarski azuka, Center Nr.: 48026 Parczew Poland 21-200
    105 Powiatowy Szpital Specjalistyczny w Stalowej Woli, Center Nr.: 48056 Stalowa Wola Poland 37-450
    106 Prywatny Gabinet Lekarski dr n. med. Piotr Gryglas, Center Nr.: 48059 Warszawa Poland 03-922
    107 Poradnia Diabetologiczna Szpitala Powiatowego w Wicborku, Center Nr.: 48003 Wicbork Poland 89-410
    108 Orodek Praktyka Lekarska Konrad Strzelczyk, Center Nr.: 48012 Woomin Poland 05-200
    109 Poradnia Diabetologiczna SPZZOZ w Wyszkowie, Center Nr.: 48067 Wyszków Poland 07-200
    110 Wojewódzka Poradnia dla Chorych na Cukrzyc, Center Nr.: 48025 Zabrze Poland 41-800
    111 Cardiomed, Center Nr.: 48019 Zielona Góra Poland 65-001
    112 Anturium, Center Nr.: 70036 Barnaul Russian Federation 656043
    113 Central city hospital, Center Nr.: 70073 Batajsk Russian Federation 346880
    114 Chelyabinsk regional clinical hospital, Center Nr.: 70069 Chelyabinsk Russian Federation 454076
    115 Limited Liability Company "Uralsky Medical Center", Center Nr.: 70063 Ekaterinburg Russian Federation 620102
    116 Scientific and Practical Center of Specialized Types of Medical Care "Uralskij Institute of Cardiology", Center Nr.: 70079 Ekaterinburg Russian Federation 620144
    117 Russian Medical Academy of Continuing Professional Education, Center Nr.: 70058 Irkutsk Russian Federation 664049
    118 The First Republican Clinical Hospital of the Ministry of Health of the Udmurt Republic, Center Nr.: 70037 Izhevsk Russian Federation 426039
    119 Central City Hospital No. 18, Center Nr.: 70051 Kazan Russian Federation 420073
    120 Kemerovo regional clinical hospital named S.V. Belyaev, Center Nr.: 70008 Kemerovo Russian Federation 50066
    121 City Polyclinic No. 16, Center Nr.: 70067 Khabarovsk Russian Federation 680045
    122 Kirov Clinical Hospital No. 7 named after V.I. Yurlova, Center Nr.: 70089 Kirov Russian Federation 610020
    123 Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo, Center Nr.: 70049 Krasnodar Russian Federation 350086
    124 Lipetsk Regional Hospital, Center Nr.: 70046 Lipetsk Russian Federation 398902
    125 SBIH Center for Speech Pathology and Neurorehabilitation MDH, Center Nr.: 70080 Moscow Russian Federation 109240
    126 Clinical Hospital No. 85 of trhe Federal Biomedical Agency, Center Nr.: 70042 Moscow Russian Federation 115409
    127 City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70043 Moscow Russian Federation 117218
    128 City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70045 Moscow Russian Federation 117218
    129 City Polyclinic No 107 of the Moscow City Healthcare Department, Center Nr.: 70082 Moscow Russian Federation 127273
    130 National Medical Research Center for Endocrinology, Center Nr.: 70025 Moskau Russian Federation 117036
    131 Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70032 Moskau Russian Federation 119034
    132 Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70041 Moskau Russian Federation 119034
    133 Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70081 Moskau Russian Federation 119034
    134 Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70084 Moskau Russian Federation 119034
    135 Vessel Clinic, Center Nr.: 70011 Moskau Russian Federation 125252
    136 City Clinical Hospital named after V.V. Veresaeva of the Moscow Department of Health, Center Nr.: 70003 Moskau Russian Federation 127644
    137 City Polyclinic No. 1, Center Nr.: 70074 Nalchik Russian Federation 360051
    138 City clinical hospital #12 of Sormovskiy district of Nizhniy Novgorod, Center Nr.: 70018 Nizhniy Novgorod Russian Federation 603003
    139 Privolzhsky Research Medical University, Center Nr.: 70085 Nizhny Novgorod Russian Federation 603005
    140 Novokuznetsk City Clinical Hospital No. 1, Center Nr.: 70050 Novokuznetsk Russian Federation 654027
    141 AVICENNA, Center Nr.: 70065 Novosibirsk Russian Federation 630007
    142 City Clinical Polyclinic #16, Center Nr.: 70056 Novosibirsk Russian Federation 630078
    143 Novosibirsk State Medical University, Center Nr.: 70059 Novosibirsk Russian Federation 6300911
    144 AVICENNA, Center Nr.: 70064 Novosibirsk Russian Federation 630099
    145 Penza regional clinical hospital named after N.N. Burdenko, Center Nr.: 70095 Penza Russian Federation 440026
    146 Private Clinic Salon Roden, Center Nr.: 70086 Perm Russian Federation 614000
    147 City clinical hospital 5, Center Nr.: 70057 Perm Russian Federation 614010
    148 City clinical hospital 5, Center Nr.: 70070 Perm Russian Federation 614010
    149 City polyclinic #16 of the City Rostov-on-Don, Center Nr.: 70027 Rostov-on-Don Russian Federation 344092
    150 North-West State Medical University named after II. Mechnikov, Center Nr.: 70053 Saint Petersbug Russian Federation 191015
    151 North-West State Medical University named after II. Mechnikov, Center Nr.: 70077 Saint Petersbug Russian Federation 191015
    152 Medilux-TM, Center Nr.: 70005 Saint Petersburg Russian Federation 197227
    153 City Pokrovskaya Hospital, Center Nr.: 70022 Saint Petersburg Russian Federation 199106
    154 First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70024 Saint-Petersburg Russian Federation 197022
    155 First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70087 Saint-Petersburg Russian Federation 197022
    156 Samara city polyclinic Nr. 9 of Oktyabrskiy district, Center Nr.: 70028 Samara Russian Federation 443110
    157 Samara city consulting and diagnostic polyclinic nr. 14, Center Nr.: 70029 Samara Russian Federation 443111
    158 Clinical Hospital of the Saratov city, Center Nr.: 70090 Saratov Russian Federation 410004
    159 LLC clinic "Family Doctor", Center Nr.: 70093 Saratov Russian Federation 410012
    160 Multifunctional Medical Clinic "Sova", Center Nr.: 70030 Saratov Russian Federation 410056
    161 V.A. Almazov National Medical Research Center, Center Nr.: 70071 St. Petersburg Russian Federation 197341
    162 AntMed, Center Nr.: 70034 St. Petersburg Russian Federation 197349
    163 Dr. Tsiberkin, Center Nr.: 70048 St. Petersburg Russian Federation 197349
    164 Zabotlivyi Doktor, Center Nr.: 70016 St. Petersburg Russian Federation 966550
    165 Regional Endocrinological Dispensary, Center Nr.: 70078 Stavropol Russian Federation 355045
    166 Tyumen State Medical University, Center Nr.: 70066 Tyumen Russian Federation 625023
    167 City clinical hospital, Center Nr.: 70019 Ufa Russian Federation 450014
    168 City Polyclinic No.2, Center Nr.: 70062 Ulan-Ude Russian Federation 670031
    169 Limited Liability Company "CENTER", Center Nr.: 70060 Vladivostok Russian Federation 690017
    170 Regional Clinical Hospital No. 2, Center Nr.: 70092 Vladivostok Russian Federation 690035
    171 Regional Clinical Hospital No. 2, Center Nr.: 70068 Vladivostok Russian Federation 690105
    172 Volgograd Regional Clinical Hospital No. 3, Center Nr.: 70076 Volgograd Russian Federation 400001
    173 Clinical Polyclinic No.28, Center Nr.: 70040 Volgograd Russian Federation 400117
    174 Voronezh City Clinical Hospital #11, Center Nr.: 70035 Voronezh Russian Federation 394042
    175 State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70017 Voronezh Russian Federation 394077
    176 State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70033 Voronezh Russian Federation 394077
    177 State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70055 Voronezh Russian Federation 394077

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    • Study Chair: Alexey Medvedchikov, +43180105-7896, Alexey.Medvedchikov@Boehringer-Ingelheim.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT03807440
    Other Study ID Numbers:
    • 1245-0187
    First Posted:
    Jan 17, 2019
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2022