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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

30 сентября 2015 г. обновлено: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

915

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Аргентина
      • Buenos Aires, Аргентина, 1431
        • Local Institution
      • Cordoba, Аргентина, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Аргентина, 1034
        • Local Institution
      • Capital Federal, Buenos Aires, Аргентина, 1429
        • Local Institution
      • Capital Federal, Buenos Aires, Аргентина, C1056ABJ
        • Local Institution
      • Capital Federal, Buenos Aires, Аргентина, C1425AGC
        • Local Institution
      • Ciudad Auton, Buenos Aires, Аргентина, C1408INH
        • Local Institution
      • Ciudad Auton., Buenos Aires, Аргентина, C1505CWB
        • Local Institution
      • Mar Del Plata, Buenos Aires, Аргентина, 7600
        • Local Institution
      • Zarate, Buenos Aires, Аргентина, 2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz, Cordoba, Аргентина, 5152
        • Local Institution
  • Бразилия
      • Rio De Janeiro, Бразилия, 20211
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Бразилия, 60021
        • Local Institution
    • Minas Gerais
      • Itajuba, Minas Gerais, Бразилия, 37502
        • Local Institution
    • Para
      • Belem, Para, Бразилия, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Бразилия, 95070
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Бразилия, 90020090
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Бразилия, 90035
        • Local Institution
    • Sao Paulo
      • Marilia, Sao Paulo, Бразилия, 17519
        • Local Institution
  • Канада
    • Alberta
      • Calgary, Alberta, Канада, T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Канада, V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Канада, E2A 4X7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Канада, A1N 1W7
        • Local Institution
      • St-John, Newfoundland and Labrador, Канада, A1E 2E2
        • Local Institution
    • Ontario
      • Sarnia, Ontario, Канада, N7T 4X3
        • Local Institution
      • Thornhill, Ontario, Канада, L4J 8L7
        • Local Institution
      • Toronto, Ontario, Канада, M4R 2G4
        • Local Institution
      • Toronto, Ontario, Канада, M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Канада, C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Канада, J2B 7T1
        • Local Institution
      • Granby, Quebec, Канада, J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette, Quebec, Канада, G2E 2X1
        • Local Institution
      • Mirabel, Quebec, Канада, J7J 2K8
        • Local Institution
      • St-Leonard, Quebec, Канада, H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Канада, S7K 3H3
        • Local Institution
      • Saskatoon, Saskatchewan, Канада, S7K 7H9
        • Local Institution
  • Мексика
      • Durango, Мексика, 64710
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Мексика, 11800
        • Local Institution
      • Guadalajara, Distrito Federal, Мексика, 44670
        • Local Institution
      • Zapopan, Distrito Federal, Мексика, 45150
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Мексика, 44650
        • Local Institution
      • Guadalajara, Jalisco, Мексика, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Мексика, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Мексика, 64460
        • Local Institution
      • Monterrrey, Nuevo Leon, Мексика, 64700
        • Local Institution
    • Tamaulipas
      • Tampico, Tamaulipas, Мексика, 89109
        • Local Institution
  • Соединенные Штаты
    • Arizona
      • Tempe, Arizona, Соединенные Штаты, 85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino, California, Соединенные Штаты, 91436
        • Medical Group of Encino
      • Fresno, California, Соединенные Штаты, 93720
        • Valley Research
      • Los Angeles, California, Соединенные Штаты, 90023
        • Randall Shue, D.O.
      • Northridge, California, Соединенные Штаты, 91325
        • Diabetes Medical Center Of California
      • San Diego, California, Соединенные Штаты, 92117
        • Ritchken & First M.D.'S
      • Spring Valley, California, Соединенные Штаты, 91978
        • Encompass Clinical Research
      • Torrance, California, Соединенные Штаты, 90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs, Colorado, Соединенные Штаты, 80909
        • Express Care Clinical Res
      • Denver, Colorado, Соединенные Штаты, 80209
        • Denver Internal Medicine
      • Golden, Colorado, Соединенные Штаты, 80401
        • New West Physicians
    • Florida
      • Altamonte Springs, Florida, Соединенные Штаты, 32701
        • Central Florida Clinical Trials, Inc.
      • Chipley, Florida, Соединенные Штаты, 32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты, 56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield, Missouri, Соединенные Штаты, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, Соединенные Штаты, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City, North Carolina, Соединенные Штаты, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark, Ohio, Соединенные Штаты, 43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle, Pennsylvania, Соединенные Штаты, 17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville, South Carolina, Соединенные Штаты, 29485
        • Palmetto Clinical Research
      • Taylors, South Carolina, Соединенные Штаты, 29687
        • Southeastern Research Assoc
    • Texas
      • Houston, Texas, Соединенные Штаты, 77081
        • Texas Center For Drug Development, P.A.
      • San Antonio, Texas, Соединенные Штаты, 78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio, Texas, Соединенные Штаты, 78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84102
        • Optimum Clinical Research
    • Washington
      • Spokane, Washington, Соединенные Штаты, 99216
        • Office Of Dr. Gray

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 77 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Key Inclusion Criteria

  • Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
  • Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
  • C-peptide ≥1.0 ng/mL
  • Body mass index ≤45.0 kg/m^2
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

  • Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
  • Serum total bilirubin level >2 mg/dL
  • Creatinine kinase level >3 times upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Лекарство: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Лекарство: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Экспериментальный: Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Лекарство: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Лекарство: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Другие имена:
  • БМС-512148
Экспериментальный: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Лекарство: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Лекарство: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Другие имена:
  • БМС-512148
Экспериментальный: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Лекарство: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Лекарство: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Лекарство: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Другие имена:
  • БМС-512148

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Скорректированное среднее изменение гемоглобина A1C (HbA1c) по сравнению с исходным уровнем на 24-й неделе (перенос последнего наблюдения [LOCF])
Временное ограничение: От исходного уровня до 24 недели
HbA1c измерялся в процентах от гемоглобина центральной лабораторией. Данные после медикаментозного лечения были исключены из этого анализа. Исходный уровень определяли как последнюю оценку перед датой и временем начала приема первой дозы двойного слепого исследуемого препарата. В тех случаях, когда время первой дозы или время оценки были недоступны, исходный уровень определялся как последняя оценка на дату или до даты первой дозы двойного слепого исследуемого препарата. Измерения HbA1c были получены во время квалификационного и вводного периодов, а также в день 1 и недели 4, 8, 12, 16, 20 и 24 двойного слепого периода.
От исходного уровня до 24 недели

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 1
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
Временное ограничение: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
Временное ограничение: From Baseline to end of Long-term Period (Week 102)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
Временное ограничение: Day 1 to Week 102
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
Временное ограничение: Baseline to Week 102
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
Baseline to Week 102
Mean Changes From Baseline in Seated Systolic Blood Pressure
Временное ограничение: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Mean Changes From Baseline in Seated Diastolic Blood Pressure
Временное ограничение: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
From Baseline to Week 102
Number of Participants With Orthostatic Hypotension
Временное ограничение: From Baseline to Week 102
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
From Baseline to Week 102

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Соавторы

Bristol-Myers Squibb

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 сентября 2007 г.

Первичное завершение (Действительный)

1 ноября 2008 г.

Завершение исследования (Действительный)

1 мая 2010 г.

Даты регистрации исследования

Первый отправленный

11 сентября 2007 г.

Впервые представлено, что соответствует критериям контроля качества

11 сентября 2007 г.

Первый опубликованный (Оценивать)

12 сентября 2007 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

20 октября 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 сентября 2015 г.

Последняя проверка

1 сентября 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • MB102-014 LT
  • MB102-014 (Другой идентификатор: Other Study ID Numbers:)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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