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AstraZeneca and Bristol-Myers Squibb to Present New Data at American Diabetes Association 73rd Scientific Sessions®

  AstraZeneca and Bristol-Myers Squibb to Present New Data at American
  Diabetes Association 73rd Scientific Sessions®

  *33 abstracts have been accepted for presentation, including data from four
    different classes of diabetes agents
  *Breadth of data underscores Alliance commitment to advancing research in
    type 1 and type 2 diabetes

Business Wire

PRINCETON, N.J. & WILMINGTON, Del. -- June 14, 2013

AstraZeneca(NYSE: AZN) and Bristol-Myers Squibb Company(NYSE: BMY) announced
today that 33 abstracts on the companies’ research in diabetes have been
accepted for presentation at the 73rd Scientific Sessions^® of the American
Diabetes Association (ADA) in Chicago, June 21-25. The data include studies
from five marketed products as well as dapagliflozin, an investigational
compound in the U.S., currently approved for use in the European Union,
Australia, New Zealand and Mexico. In addition to blood glucose control,
studies presented at the meeting examine impact on cardiovascular risk factors
such as weight and blood pressure, which are important to overall disease
management in people with diabetes.

“The AstraZeneca and Bristol-Myers Squibb Alliance will present data on a
broad, versatile portfolio including Onglyza, Kombiglyze XR, Symlin, Byetta
and Bydureon, as well as the investigational compound dapagliflozin,” said
John Yee, MD, MPH, vice president, head of Medical Affairs,
AstraZeneca/Bristol-Myers Squibb U.S. Diabetes Alliance. “The diversity of
data reflects our joint commitment to researching and delivering innovative
medicines and treatment options to help patients overcome the burdens of
diabetes.”

Key presentations include:

  *The first presentation of Phase IIa pilot data exploring the use of
    dapagliflozin in adult patients with type 1 diabetes (late-breaking
    poster, 70-LB)
  *Four-year data examining the durability of dapagliflozin vs. glipizide as
    add-on therapies in patients with type 2 diabetes inadequately controlled
    on metformin (late-breaking poster, 62-LB)
  *Study evaluating the efficacy and tolerability of saxagliptin in patients
    with type 2 diabetes and a history of cardiovascular disease (poster
    1174-P)
  *Three-year data from a study examining the effect of exenatide once weekly
    on sustained glycemic control and weight compared with insulin glargine
    (oral presentation, 67-OR)
  *Phase IV study examining glycemic control, weight, and hypoglycemia with
    exenatide compared to mealtime administration of rapid-acting analog
    insulin (oral presentation, 70-OR)

The complete list of AstraZeneca and Bristol-Myers Squibb data presentations
is below and can also be accessed on the ADA website.

                                                                        
                                                    Date/Time
Presentations                                    
                                                    All times are CDT
Bydureon^® (exenatide extended-release for injectable suspension) and
Byetta^® (exenatide)  Clinical Data
                                                 
Exenatide Once Weekly: Data on Glycemic Control     June 22, 8:30 a.m. –
and Weight Through 3 Years Compared with          8:45 a.m.
Insulin Glargine (oral presentation, 67-OR)
Exenatide BID vs Insulin Lispro TID Added to
Titrated Insulin Glargine QD in                     June 22, 9:15 a.m –
Metformin-Treated T2DM Patients Impact on         9:30 a.m.
Glycemic Control, Weight and Hypoglycemia: the
4B Study (oral presentation, 70-OR)
Efficacy and Tolerability of Exenatide Twice        June 22, 11:30 a.m. –
Daily in Asian vs White Patients with T2DM        1:30 p.m
(poster 1035-P)
Quantification of the Benefit-Risk Relationship
Between Glycemic Control and Hypoglycemia: A      June 22, 11:30 a.m. –
Comparison of Exenatide Once Weekly with            1:30 p.m
Titrated Insulin Glargine (poster 1034-P)
Affect of Relative β-cell Function on A1C and       June 22, 11:30 a.m. –
Fasting Glucose with Exenatide in T2DM Patients   1:30 p.m
(poster 1023-P)
Add-on Treatment with Exenatide Once Weekly vs      June 22, 11:30 a.m. –
Daily Basal Insulin in Patients with A1C ≥8.5%    1:30 p.m
(poster 1018-P)
Exenatide Once Weekly: Association Between          June 23, 1 – 2 p.m.
Weight Response, Glycemic Control, and Markers    (Guided poster tour)
of Cardiovascular Risk (poster 1182-P)
Onglyza^® (saxagliptin) ^  and Kombiglyze™ XR  (saxagliptin and metformin
HCl extended-release tablets) Clinical Data
Saxagliptin (SAXA) as Add-on to Metformin (MET)
+ Sulfonylurea (SU): Outcomes Stratified by       June 23, Noon – 2 p.m.
Baseline A1C and Patient Characteristics
(poster 1134-P)
Efficacy and Tolerability of Saxagliptin (SAXA)
in Patients With Type 2 Diabetes Mellitus         June 23, Noon – 2 p.m.
(T2DM) and a History of Cardiovascular Disease
(CVD) (poster 1174-P)
Efficacy and Safety of Saxagliptin (SAXA) in
Patients With Type 2 Diabetes (T2DM) and High     June 23, Noon – 2 p.m.
Framingham 10-Year Cardiovascular (CV) Risk
(poster 1135-P)
Early Onset of Increased Hypoglycemic Incidence
With Glipizide (GLIP) vs Saxagliptin (SAXA) in    June 23, Noon – 2 p.m.
Type 2 Diabetes Patients on Metformin (poster
1151-P)
Efficacy and Safety of Saxagliptin (SAXA) in
Patients With Type 2 Diabetes Receiving           June 23, Noon – 2 p.m.
Concomitant Statin Therapy (poster 1133-P)
Efficacy and Safety of Saxagliptin (SAXA) in
Adult Diabetes Patients With GAD Antibodies       June 23, Noon – 2 p.m.
(poster 1107-P)
Symlin^® (pramlintide acetate) Injection Clinical Data
Effects of Pramlintide on A1C, Weight, and
Hypoglycemia in Patients with Type 1 or Type 2    June 22, 11:30 a.m. –
Diabetes: Subgroup Analysis by Duration of          1:30 p.m.
Diabetes (poster 1036-P)
Health Economics Outcomes Research Data
Long-Term Cardiovascular Outcomes with
Exenatide Twice Daily Compared to Insulin: A      June 23, Noon – 2 p.m.
Retrospective Observational Study (poster
1420-P)
Functional Status of Patients with Type 2
Diabetes Mellitus: Is it the Diagnosis or         June 23, Noon – 2 p.m.
Underlying Risk Factors Promoting Ill Health?
(poster 1481-P)
Association of ≥5% Weight Loss and
Self-Reported Adherence with 6-month Glycemic     June 23, Noon – 2 p.m.
Control in Type 2 Diabetes Mellitus (T2DM): the
DELTA Study (poster 1227-P)
Quality of Care for Type 2 Diabetes Mellitus
Patients in Dubai: A Retrospective Cohort Study   June 23, Noon – 2 p.m.
(poster 1286-P)
Understanding Clinical Inertia: Are Patient or      June 22, 12:30 p.m. –
Provider Characteristics Predictive of Glycemic   1:30 p.m. (Guided
Control? (poster 1222-P)                            poster tour)
Real-World Cardiovascular Event Rates among
High-risk Adults with Type 2 Diabetes Mellitus    June 23, Noon – 2 p.m.
(poster 1408-P)
High Mortality and Cardiovascular Event Rates
within Type 2 Diabetes Mellitus (T2DM) Patients
with Established Cardiovascular Disease (CVD)     June 23, Noon – 2 p.m.
or CVD Risk Factors in a Large US Database
(poster 1426-P)
Cardiovascular Event Rates in a Type 2 Diabetes
Population in a Real-World UK Setting: A Large
Database Study Using the Clinical Practice        June 23, Noon – 2 p.m.
Research Datalink (CPRD) and Hospital Episode
Statistics (HES) (poster 1414-P)
Resource Use of Type 2 Diabetes Mellitus
Patients Following Initiation with Saxagliptin    June 23, Noon – 2 p.m.
or Sitagliptin (poster 1260-P)
Combination Therapy With Metformin Plus
Sulfonylureas Versus Metformin Plus DPP-4         June 23, Noon – 2 p.m.
Inhibitors and Risk of All-Cause Mortality
(late-breaking poster, 112-LB)
Investigational Dapagliflozin Clinical Data
Exploring the Potential of Dapagliflozin in
Type 1 Diabetes: Phase 2a Pilot Study             June 23, Noon – 2 p.m.
(late-breaking poster, 70-LB)
Durability of Dapagliflozin vs Glipizide as
Add-on Therapies in T2DM Inadequately             June 23, Noon – 2 p.m.
Controlled on Metformin: 4-year Data
(late-breaking poster, 62-LB)
Perspectives on T2DM from Clinicians and from       June 22, 11:30 a.m. –
People with T2DM in China: the EXPLORE Global     1:30 p.m.
Survey (poster 849-P)
Dapagliflozin Effects on the Lipid Profile of       June 23, Noon – 1 p.m.
Patients with Type 2 Diabetes Mellitus (poster    (Guided poster tour)
1188-P)
Efficacy and Safety of Dapagliflozin
Monotherapy in Japanese Patients with Type 2      June 23, Noon – 2 p.m.
Diabetes Inadequately Controlled with Diet and
Exercise (poster 1163-P)
Effect of Dapagliflozin as Part of Triple
Combination Therapy on HbA1c and Body Weight in   June 23, Noon – 2 p.m.
Patients with Type 2 Diabetes (poster 1176-P)
Dapagliflozin as Monotherapy in Drug-Naïve
Asian Patients with T2DM Inadequately             June 23, Noon – 2 p.m.
Controlled on Diet and Exercise (poster 1105-P)
Response to Dapagliflozin by Baseline HbA1c in    June 23, Noon – 2 p.m.
Head-to-Head Comparisons (poster 1116-P)
Effect of Add-On Dapagliflozin on Frequency of
Combined HbA1c and Weight Reduction Versus          June 23, 4:30 p.m. –
Add-On Glipizide in Patients with Type 2          6:30 p.m.
Diabetes Inadequately Controlled on Metformin
(oral presentation, 236-OR)
                                                 

INDICATION and IMPORTANT SAFETY INFORMATION for BYDUREON^®
(exenatide extended-release for injectable suspension)

Indication and Important Limitations of Use for BYDUREON:

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in multiple clinical settings.

• Because of the uncertain relevance of the rat thyroid C-cell tumor findings
to humans, prescribe only to patients for whom potential benefits are
considered to outweigh potential risk.

• Not recommended as first-line therapy for patients who have inadequate
glycemic control on diet and exercise.

• Not a substitute for insulin, should not be used in patients with type 1
diabetes or diabetic ketoacidosis, and cannot be recommended for use with
insulin.

• BYDUREON and BYETTA^® (exenatide) injection both contain the same active
ingredient, exenatide, and should not be used together.

• Exenatide has been associated with acute pancreatitis, including fatal and
non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing
data. It is unknown whether patients with a history of pancreatitis are at
increased risk for pancreatitis while using BYDUREON; consider other
antidiabetic therapies for these patients.

Important Safety Information for BYDUREON:

BOXED WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes an increased incidence in thyroid C-cell
tumors at clinically relevant exposures in rats compared to controls. It is
unknown whether BYDUREON causes thyroid C-cell tumors, including medullary
thyroid carcinoma (MTC), in humans, as human relevance could not be determined
by clinical or nonclinical studies. BYDUREON is contraindicated in patients
with a personal or family history of MTC and in patients with Multiple
Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or
thyroid ultrasound monitoring is of uncertain value in patients treated with
BYDUREON. Patients should be counseled regarding the risk and symptoms of
thyroid tumors.

Contraindications

  *Patients with a personal or family history of MTC and in patients with
    Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  *Patients with prior serious hypersensitivity reactions to exenatide or to
    any of the product components.

Warnings and Precautions

  *Pancreatitis: Based on postmarketing data, exenatide has been associated
    with acute pancreatitis, including fatal and non-fatal hemorrhagic or
    necrotizing pancreatitis. After initiation of BYDUREON, observe patients
    carefully for pancreatitis (persistent severe abdominal pain, sometimes
    radiating to the back, with or without vomiting). If pancreatitis is
    suspected, BYDUREON should be discontinued promptly and should not be
    restarted if pancreatitis is confirmed.
  *Hypoglycemia: Increased risk of hypoglycemia when used in combination with
    a sulfonylurea (SFU). Clinicians may consider reducing the SFU dose to
    minimize risk of hypoglycemia. It is possible that use of BYDUREON with
    other glucose-independent insulin secretagogues (eg, meglitinides) could
    increase the risk of hypoglycemia.
  *Renal Impairment: Should not be used in patients with severe renal
    impairment or end-stage renal disease. Use with caution in patients with
    renal transplantation or moderate renal failure. Postmarketing reports of
    altered renal function with exenatide, including increased serum
    creatinine, renal impairment, worsened chronic renal failure, and acute
    renal failure, sometimes requiring hemodialysis and kidney
    transplantation.
  *Gastrointestinal Disease: Because exenatide is commonly associated with
    gastrointestinal adverse reactions, BYDUREON is not recommended in
    patients with severe gastrointestinal disease (eg, gastroparesis).
  *Immunogenicity: Patients may develop antibodies to exenatide. In 5
    registration trials, attenuated glycemic response was associated in 6% of
    BYDUREON-treated patients with antibody formation. If worsening of or
    failure to achieve adequate glycemic control occurs, consider alternative
    antidiabetic therapy.
  *Hypersensitivity: Postmarketing reports of serious hypersensitivity
    reactions (eg, anaphylaxis and angioedema). If this occurs, patients
    should discontinue BYDUREON and other suspect medications and promptly
    seek medical advice.
  *Macrovascular Outcomes: No clinical studies establishing conclusive
    evidence of macrovascular risk reduction with BYDUREON or any other
    antidiabetic drug.

Withdrawals

  *In 5 comparator-controlled, 24- to 30-week BYDUREON trials, the incidence
    of withdrawal due to adverse events was 4.9% for BYDUREON, 4.9% for
    BYETTA, and 2.0% for other comparators. The most common adverse reactions
    leading to withdrawal for BYDUREON, BYETTA, and comparators respectively
    were nausea (0.5%, 1.5%, 0.3%), injection-site nodule (0.5%, 0.0%, 0.0%),
    diarrhea (0.3%, 0.4%, 0.3%), injection-site reaction (0.2%, 0.0%, 0.0%),
    and headache (0.2%, 0.0%, 0.0%). One percent of BYDUREON patients withdrew
    due to injection-site adverse reactions.

Most Common Adverse Reactions (≥5%)

  *BYDUREON vs BYETTA:

       *24-week trial: nausea (14% vs 35%), diarrhea (9.3% vs 4.1%),
         injection-site erythema (5.4% vs 2.4%).
       *30-week trial: nausea (27% vs 33.8%), diarrhea (16.2% vs 12.4%),
         vomiting (10.8% vs 18.6%), injection-site pruritus (18.2% vs 1.4%),
         constipation (10.1% vs 6.2%), gastroenteritis viral (8.8% vs 5.5%),
         gastroesophageal reflux disease (7.4% vs 4.1%), dyspepsia (7.4% vs
         2.1%), injection-site erythema (7.4% vs 0.0%), fatigue (6.1% vs
         3.4%), headache (6.1% vs 4.8%), injection-site hematoma (5.4% vs
         11.0%).

  *BYDUREON vs titrated insulin glargine: nausea (12.9% vs 1.3%), headache
    (9.9% vs 7.6%), diarrhea (9.4% vs 4.0%), injection-site nodule (6.0% vs
    0.0%).
  *Combination trial vs sitagliptin and pioglitazone: nausea (24.4% vs 9.6%
    and 4.8%), diarrhea (20.0% vs 9.6% and 7.3%), vomiting (11.3% vs 2.4% and
    3.0%), headache (9.4% vs 9.0% and 5.5%), constipation (6.3% vs 3.6% and
    1.2%), fatigue (5.6% vs 0.6% and 3.0%), dyspepsia (5.0% vs 3.6% and 2.4%),
    decreased appetite (5.0% vs 1.2% and 0.0%), injection-site pruritus (5.0%
    vs 4.8% and 1.2%).
  *Monotherapy trial vs sitagliptin, pioglitazone, and metformin: nausea
    (11.3% vs 3.7%, 4.3%, and 6.9%), diarrhea (10.9% vs 5.5%, 3.7%, and
    12.6%), injection-site nodule (10.5% vs 6.7%, 3.7%, and 10.2%),
    constipation (8.5% vs 2.5%, 1.8%, and 3.3%), headache (8.1% vs 9.2%, 8.0%,
    and 12.2%), dyspepsia (7.3% vs 1.8%, 4.9%, and 3.3%).
  *Hypoglycemia: No major hypoglycemia was reported for BYDUREON- or
    comparator-treated patients in five 24- to 30-week trials. Minor
    hypoglycemia incidences for BYDUREON vs comparator-treated patients were
    as follows: 24-week trial vs BYETTA: with SFU, 12.5% vs 11.8%; without
    SFU, 0.0% for both; 30-week trial vs BYETTA: with SFU, 14.5% vs 15.4%;
    without SFU, 0.0% vs 1.1%; monotherapy trial vs sitagliptin, pioglitazone,
    and metformin: 2.0% vs 0.0% (all comparators); combination trial vs
    sitagliptin and pioglitazone: 1.3% vs 3.0% and 1.2%; vs titrated insulin
    glargine, with SFU, 20.0% vs 43.9%; without SFU, 3.7% vs 19.1%.
  *Injection-site reactions were observed more frequently in BYDUREON-treated
    patients (17.1%) vs patients treated with BYETTA (12.7%), titrated insulin
    glargine (1.8%), or placebo injection (6.4%-13.0%). Injection-site
    reactions were observed in 14.2% of antibody-positive patients vs 3.1% of
    antibody-negative patients, with higher incidence in those with
    higher-titer antibodies. BYETTA-treated patients had similar incidence
    between antibody-positive and antibody-negative patients (5.8% vs 7.0%).
    Small, asymptomatic, subcutaneous injection-site nodules are seen with the
    use of BYDUREON.

Drug Interactions

  *Oral Medications: BYDUREON slows gastric emptying and can reduce the rate
    of absorption of orally administered drugs. Use with caution with oral
    medications.
  *Warfarin: Postmarketing reports with exenatide of increased international
    normalized ratio (INR) sometimes associated with bleeding with concomitant
    use of warfarin. Monitor INR frequently until stable upon initiation or
    alteration of BYDUREON.

Use in Specific Populations

  *Pregnant and Nursing Women: Based on animal data, BYDUREON may cause fetal
    harm and should be used during pregnancy only if the potential benefit
    justifies the potential risk to the fetus. To report drug exposure during
    pregnancy call 1-800-633-9081. When administered to a nursing woman, a
    decision should be made whether to discontinue nursing or to discontinue
    BYDUREON.
  *Pediatric Patients: Use in pediatric patients is not recommended as safety
    and effectiveness have not been established.

Please click here for US Full Prescribing Information for BYDUREON (exenatide
extended-release for injectable suspension) 2mg, including Boxed WARNING
regarding risk of thyroid C-cell tumors, and click here for Medication Guide.

INDICATION and IMPORTANT SAFETY INFORMATION for BYETTA^® (exenatide) Injection

Indication and Important Limitations of Use for BYETTA:

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.

  *Not a substitute for insulin and should not be used in patients with type
    1 diabetes or diabetic ketoacidosis.
  *Concurrent use with prandial insulin has not been studied and cannot be
    recommended.
  *BYETTA has been associated with acute pancreatitis, including fatal and
    non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing
    data. It is unknown whether patients with a history of pancreatitis are at
    increased risk for pancreatitis while using BYETTA; consider other
    antidiabetic therapies for these patients.

Important Safety Information for BYETTA:

Contraindications

  *BYETTA is contraindicated in patients with prior severe hypersensitivity
    reactions to exenatide or to any of the product components.

Warnings and Precautions

  *Pancreatitis: Based on postmarketing data BYETTA has been associated with
    acute pancreatitis, including fatal and non-fatal hemorrhagic or
    necrotizing pancreatitis. After initiation and dose increases of BYETTA,
    observe patients carefully for pancreatitis (including persistent severe
    abdominal pain, sometimes radiating to the back, with or without
    vomiting). If pancreatitis is suspected, BYETTA should be discontinued
    promptly and should not be restarted if pancreatitis is confirmed.
  *Hypoglycemia: Increased risk of hypoglycemia when used in combination with
    a sulfonylurea (SU) or when used with a glucose-independent insulin
    secretagogues (eg, meglitinides). Clinicians may consider reducing the SU
    dose in patients receiving BYETTA to reduce the risk of hypoglycemia. When
    used with insulin, evaluate and consider reducing the insulin dose in
    patients at increased risk of hypoglycemia.
  *Renal Impairment: Should not be used in patients with severe renal
    impairment or end-stage renal disease. Use with caution in patients with
    renal transplantation or when initiating or escalating the dose in
    patients with moderate renal failure. Postmarketing reports of altered
    renal function, including increased serum creatinine, renal impairment,
    worsened chronic renal failure, and acute renal failure, sometimes
    requiring hemodialysis and kidney transplantation.
  *Gastrointestinal Disease: Because exenatide is commonly associated with
    gastrointestinal adverse reactions, BYETTA is not recommended in patients
    with severe gastrointestinal disease (eg, gastroparesis).
  *Immunogenicity: Patients may develop antibodies to exenatide. In 3
    registration trials, antibody levels were measured in 90% of patients,
    with up to 4% of patients having high-titer antibodies and attenuated
    glycemic response. If worsening of or failure to achieve adequate glycemic
    control occurs, consider alternative antidiabetic therapy.
  *Hypersensitivity: Postmarketing reports of serious hypersensitivity
    reactions (eg, anaphylaxis and angioedema). If this occurs, patients
    should discontinue BYETTA and other suspect medications and promptly seek
    medical advice.
  *Macrovascular Outcomes: No clinical studies establishing conclusive
    evidence of macrovascular risk reduction with BYETTA or any other
    antidiabetic drug.

Most Common Adverse Reactions (≥5%)

  *24-week monotherapy trial vs placebo (PBO): nausea (8% vs 0%).
  *Three 30-week combination trials of BYETTA added to metformin (MET) and/or
    SU vs PBO: nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs
    6%), feeling jittery (9% vs 4%), dizziness (9% vs 6%), headache (9% vs
    6%), dyspepsia (6% vs 3%).
  *16-week trial of BYETTA added to thiazolidinedione (TZD) ± MET vs PBO:
    nausea (40% vs 15%), vomiting (13% vs 1%), dyspepsia (7% vs 1%), diarrhea
    (6% vs 3%).
  *30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO:
    nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%), headache
    (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%), asthenia (5%
    vs 1%).
  *Hypoglycemia: BYETTA as monotherapy vs PBO, 3.8% (10 mcg) and 5.2% (5 mcg)
    vs 1.3%; BYETTA vs PBO, with metformin (MET): 5.3% (10 mcg) and 4.5% (5
    mcg) vs 5.3%; with SU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with MET
    + SU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10 mcg)
    vs 7.1%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
  *Withdrawals: monotherapy trial: 2 of 155 BYETTA patients withdrew due to
    headache and nausea vs 0 PBO-treated patients. Three 30-week combination
    trials of BYETTA added to MET and/or SU vs PBO: nausea (3% vs <1%),
    vomiting (1% vs 0). 16-week trial of BYETTA added to TZD ± MET vs PBO:
    nausea (9%) and vomiting (5%), with <1% PBO patients withdrawing due to
    nausea. 30-week trial of BYETTA added to insulin glargine ± MET and/or TZD
    vs PBO: nausea (5.1% vs 0), vomiting (2.9% vs 0).

Drug Interactions

  *Oral Medications: BYETTA slows gastric emptying and can reduce the extent
    and rate of absorption of orally administered drugs. Use with caution with
    medications that have a narrow therapeutic index or require rapid
    gastrointestinal absorption. Oral medications dependent on threshold
    concentrations for efficacy, such as contraceptives or antibiotics, should
    be taken at least 1 hour before BYETTA.
  *Warfarin: Postmarketing reports of increased international normalized
    ratio (INR) sometimes associated with bleeding with concomitant use of
    warfarin. Monitor INR frequently until stable upon initiation or
    alteration of BYETTA.

Use in Specific Populations

  *Pregnant and Nursing Women: Based on animal data, BYETTA may cause fetal
    harm and should be used during pregnancy only if the potential benefit
    justifies the potential risk to the fetus. To report drug exposure during
    pregnancy call 1-800-633-9081. When administered to a nursing woman, a
    decision should be made whether to discontinue nursing or discontinue
    BYETTA.
  *Pediatric Patients: Use in pediatric patients is not recommended as safety
    and effectiveness have not been established.

Please click here for the US full Prescribing Information for BYETTA^®
(exenatide) injection 5 mcg and 10 mcg, and click here for the Medication
Guide.

INDICATION and IMPORTANT SAFETY INFORMATION for ONGLYZA^® (saxagliptin)

Indication and Limitations of Use for ONGLYZA:

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in multiple clinical settings.

ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or
diabetic ketoacidosis.

ONGLYZA has not been studied in patients with a history of pancreatitis.

Important Safety Information for ONGLYZA:

Contraindications

  *History of a serious hypersensitivity reaction to ONGLYZA (eg,
    anaphylaxis, angioedema, or exfoliative skin conditions)

Warnings and Precautions

  *Pancreatitis: There have been postmarketing reports of acute pancreatitis
    in patients taking ONGLYZA. After initiating ONGLYZA, observe patients
    carefully for signs and symptoms of pancreatitis. If pancreatitis is
    suspected, promptly discontinue ONGLYZA and initiate appropriate
    management. It is unknown whether patients with a history of pancreatitis
    are at increased risk of developing pancreatitis while using ONGLYZA.
  *Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin: When ONGLYZA
    was used in combination with a sulfonylurea or with insulin, medications
    known to cause hypoglycemia, the incidence of confirmed hypoglycemia was
    increased over that of placebo used in combination with a sulfonylurea or
    with insulin. Therefore, a lower dose of the insulin secretagogue or
    insulin may be required to minimize the risk of hypoglycemia when used in
    combination with ONGLYZA.
  *Hypersensitivity Reactions: There have been postmarketing reports of
    serious hypersensitivity reactions in patients treated with ONGLYZA,
    including anaphylaxis, angioedema, and exfoliative skin conditions. Onset
    of these reactions occurred within the first 3 months after initiation of
    treatment with ONGLYZA, with some reports occurring after the first dose.
    If a serious hypersensitivity reaction is suspected, discontinue ONGLYZA,
    assess for other potential causes for the event, and institute alternative
    treatment for diabetes. Use caution in patients with a history of
    angioedema to another DPP-4 inhibitor as it is unknown whether they will
    be predisposed to angioedema with ONGLYZA.
  *Macrovascular Outcomes: There have been no clinical studies establishing
    conclusive evidence of macrovascular risk reduction with ONGLYZA or any
    other antidiabetic drug.

Most Common Adverse Reactions

  *Most common adverse reactions reported in ≥5% of patients treated with
    ONGLYZA and more commonly than in patients treated with control were upper
    respiratory tract infection (7.7%, 7.6%), headache (7.5%, 5.2%),
    nasopharyngitis (6.9%, 4.0%) and urinary tract infection (6.8%, 6.1%).
  *When used as add-on combination therapy with a thiazolidinedione, the
    incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was
    3.1%, 8.1% and 4.3%, respectively.
  *Confirmed hypoglycemia was reported more commonly in patients treated with
    ONGLYZA 2.5 mg and ONGLYZA 5 mg compared to placebo in the add-on to
    glyburide trial (2.4%, 0.8% and 0.7%, respectively), with ONGLYZA 5 mg
    compared to placebo in the add-on to insulin (with or without metformin)
    trial (5.3% and 3.3%, respectively), with ONGLYZA 2.5 mg compared to
    placebo in the renal impairment trial (4.7% and 3.5%, respectively), and
    with ONGLYZA 5 mg compared to placebo in the add-on to metformin plus
    sulfonylurea trial (1.6% and 0.0%, respectively).

Drug Interactions

Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin
exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered
with a strong CYP3A4/5 inhibitor (eg, atazanavir, clarithromycin, indinavir,
itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and
telithromycin).

Use in Specific Populations

  *Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily
    for patients with moderate or severe renal impairment, or with end-stage
    renal disease requiring hemodialysis (creatinine clearance [CrCl] ≤50
    mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA
    has not been studied in patients undergoing peritoneal dialysis.
    Assessment of renal function is recommended prior to initiation of ONGLYZA
    and periodically thereafter.
  *Pregnant and Nursing Women: There are no adequate and well-controlled
    studies in pregnant women. ONGLYZA, like other antidiabetic medications,
    should be used during pregnancy only if clearly needed. It is not known
    whether saxagliptin is secreted in human milk. Because many drugs are
    secreted in human milk, caution should be exercised when ONGLYZA is
    administered to a nursing woman.
  *Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric
    patients have not been established.

Please click here for US Full Prescribing Information for Onglyza (5 mg
tablets), and click here for Medication Guide.

INDICATION and IMPORTANT SAFETY INFORMATION for KOMBIGLYZE™ XR (saxagliptin
and metformin HCl extended-release) tablets

Indication and Limitations of Use for KOMBIGLYZE XR:

KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus when treatment with
both saxagliptin and metformin is appropriate.

KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus
or diabetic ketoacidosis.

KOMBIGLYZE XR has not been studied in patients with a history of pancreatitis.

Important Safety Information for KOMBIGLYZE XR:

BOXED WARNING: LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to
metformin accumulation. The risk increases with conditions such as sepsis,
dehydration, excess alcohol intake, hepatic impairment, renal impairment, and
acute congestive heart failure.

The onset of lactic acidosis is often subtle, accompanied only by nonspecific
symptoms such as malaise, myalgias, respiratory distress, increasing
somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated
blood lactate.

If acidosis is suspected, KOMBIGLYZE XR should be discontinued and the patient
hospitalized immediately. [See Warnings and Precautions]

Contraindications

  *Renal impairment (eg, serum creatinine levels ≥1.5 mg/dL for men, ≥1.4
    mg/dL for women, or abnormal creatinine clearance)
  *Hypersensitivity to metformin hydrochloride
  *Acute or chronic metabolic acidosis, including diabetic ketoacidosis
  *History of a serious hypersensitivity reaction to KOMBIGLYZE XR or
    saxagliptin (eg, anaphylaxis, angioedema, or exfoliative skin conditions)

Warnings and Precautions

  *The reported incidence of lactic acidosis in patients receiving metformin
    is very low (approximately 0.03 cases/1000 patient-years). When it occurs,
    it is fatal in approximately 50% of cases. Reported cases of lactic
    acidosis have occurred primarily in diabetic patients with significant
    renal insufficiency.
  *Patients with congestive heart failure requiring pharmacologic management,
    in particular those with unstable or acute congestive heart failure who
    are at risk of hypoperfusion and hypoxemia, are at increased risk of
    lactic acidosis.
  *Lactic acidosis risk increases with the degree of renal dysfunction and
    patient age. The risk may be significantly decreased by use of minimum
    effective dose of metformin and regular monitoring of renal function.
    Careful renal monitoring is particularly important in the elderly.
    KOMBIGLYZE XR should not be initiated in patients ≥80 years of age unless
    measurement of creatinine clearance demonstrates that renal function is
    not reduced.
  *Withhold KOMBIGLYZE XR in the presence of any condition associated with
    hypoxemia, dehydration, or sepsis.
  *There have been postmarketing reports of acute pancreatitis in patients
    taking saxagliptin. After initiating KOMBIGLYZE XR, observe patients
    carefully for signs and symptoms of pancreatitis. If pancreatitis is
    suspected, promptly discontinue KOMBIGLYZE XR and initiate appropriate
    management. It is unknown whether patients with a history of pancreatitis
    are at increased risk of developing pancreatitis while using KOMBIGLYZE
    XR.
  *Before initiation of KOMBIGLYZE XR, and at least annually thereafter,
    renal function should be assessed and verified as normal.
  *KOMBIGLYZE XR is not recommended in patients with hepatic impairment.
  *Metformin may lower vitamin B12 levels. Measure hematological parameters
    annually.
  *Warn patients against excessive alcohol intake.
  *KOMBIGLYZE XR should be suspended for any surgical procedure (except minor
    procedures not associated with restricted intake of food and fluids), and
    should not be restarted until patient’s oral intake has resumed and renal
    function is normal.
  *Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin

       *Saxagliptin: When saxagliptin was used in combination with a
         sulfonylurea or with insulin, medications known to cause
         hypoglycemia, the incidence of confirmed hypoglycemia was increased
         over that of placebo used in combination with a sulfonylurea or with
         insulin. Therefore, a lower dose of the insulin secretagogue or
         insulin may be required to minimize the risk of hypoglycemia when
         used in combination with KOMBIGLYZE XR.
       *Metformin: Hypoglycemia does not occur in patients receiving
         metformin alone under usual circumstances of use, but could occur
         when caloric intake is deficient, when strenuous exercise is not
         compensated by caloric supplementation, during concomitant use with
         other glucose-lowering agents (such as sulfonylureas or insulin), or
         with use of ethanol. Elderly, debilitated, or malnourished patients
         and those with adrenal or pituitary insufficiency or alcohol
         intoxication are particularly susceptible to hypoglycemic effects.

  *Intravascular contrast studies with iodinated materials can lead to acute
    alteration of renal function and have been associated with lactic acidosis
    in patients receiving metformin. KOMBIGLYZE XR should be temporarily
    discontinued at the time of or prior to the procedure, and withheld for 48
    hours after the procedure and reinstituted only after renal function is
    normal.
  *There have been postmarketing reports of serious hypersensitivity
    reactions in patients treated with saxagliptin, including anaphylaxis,
    angioedema, and exfoliative skin conditions. Onset of these reactions
    occurred within the first 3 months after initiation of treatment with
    saxagliptin, with some reports occurring after the first dose. If a
    serious hypersensitivity reaction is suspected, discontinue KOMBIGLYZE XR,
    assess for other potential causes for the event, and institute alternative
    treatment for diabetes. Use caution in patients with a history of
    angioedema to another DPP-4 inhibitor as it is unknown whether they will
    be predisposed to angioedema with KOMBIGLYZE XR.
  *There have been no clinical studies establishing conclusive evidence of
    macrovascular risk reduction with KOMBIGLYZE XR or any other anti-diabetic
    drug.

Adverse Reactions

  *Adverse reactions reported in >5% of patients treated with metformin
    extended-release and more commonly than in patients treated with placebo
    were: diarrhea (9.6% vs 2.6%) and nausea/vomiting (6.5% vs 1.5%).
  *Adverse reactions reported in ≥5% of patients treated with saxagliptin and
    more commonly than in patients treated with placebo were: upper
    respiratory tract infection (7.7% vs 7.6%), urinary tract infection (6.8%
    vs 6.1%), and headache (6.5% vs 5.9%).
  *Adverse reactions reported in ≥5% of treatment-naive patients treated with
    coadministered saxagliptin and metformin immediate-release (IR) and more
    commonly than in patients treated with metformin IR alone were: headache
    (7.5% vs 5.2%) and nasopharyngitis (6.9% vs 4.0%).
  *Confirmed hypoglycemia was reported more commonly in patients treated with
    saxagliptin 5 mg compared to placebo in the add-on to insulin (with or
    without metformin) trial (5.3% and 3.3%, respectively). Among the patients
    using insulin with metformin, the incidence of confirmed hypoglycemia was
    4.8% with saxagliptin vs 1.9% with placebo. Confirmed hypoglycemia was
    reported more commonly with saxagliptin 5 mg compared to placebo in the
    add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively).

Drug Interactions

Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin
exposure, limit KOMBIGLYZE XR to 2.5 mg/1000 mg once daily when coadministered
with a strong CYP3A4/5 inhibitor (eg, atazanavir, clarithromycin, indinavir,
itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and
telithromycin).

Use in Specific Populations

  *Pregnant and Nursing Women: There are no adequate and well-controlled
    studies in pregnant women. KOMBIGLYZE XR should be used during pregnancy
    only if clearly needed. It is not known whether saxagliptin or metformin
    are secreted in human milk. Because many drugs are secreted in human milk,
    caution should be exercised when KOMBIGLYZE XR is administered to a
    nursing woman.
  *Pediatric Patients: Safety and effectiveness of KOMBIGLYZE XR in pediatric
    patients have not been established.

Please click here for US Full Prescribing Information for KOMBIGLYZE XR
(5/500*5/1000*2.5/1000 mg tablets), including Boxed WARNING about lactic
acidosis, and click here for Medication Guide.

INDICATIONS and IMPORTANT SAFETY INFORMATION for Symlin^® (pramlintide
acetate) Injection

Indications:

Symlin^® (pramlintide acetate) is indicated as adjunct treatment in adults
with type 1 or type 2 diabetes who use mealtime insulin therapy and who have
failed to achieve desired glucose control despite optimal insulin therapy
(with or without a concurrent sulfonylurea agent and/or metformin in type 2
diabetes).

Important Safety Information:

BOXED WARNING: SEVERE HYPOGLYCEMIA

SYMLIN is used with insulin and has been associated with an increased risk of
insulin induced severe hypoglycemia, particularly in patients with type 1
diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is
seen within 3 hours following a SYMLIN injection. If severe hypoglycemia
occurs while operating a motor vehicle, heavy machinery, or while engaging in
other high-risk activities, serious injuries may occur. Appropriate patient
selection, careful patient instruction, and insulin dose adjustments are
critical elements for reducing this risk.

Contraindications

  *Known hypersensitivity to SYMLIN or any of its components, including
    metacresol
  *Confirmed diagnosis of gastroparesis
  *Hypoglycemia unawareness

Warnings

Proper patient selection is critical to safe and effective use of SYMLIN:
Review HbA1c, recent blood glucose monitoring data, history of insulin-induced
hypoglycemia, current insulin regimen, and body weight before initiation of
therapy. Only consider SYMLIN for patients with insulin-using type 2 or type 1
diabetes who fulfill the following criteria:

  *have failed to achieve adequate glycemic control despite individualized
    insulin management
  *are receiving ongoing care under the guidance of a healthcare professional
    skilled in insulin-use and supported by a diabetes educator

Do NOT consider SYMLIN for patients meeting any of the following criteria:

  *poor compliance with current insulin regimen
  *poor compliance with prescribed self-blood glucose monitoring
  *HbA1c >9%
  *recurrent severe hypoglycemia requiring assistance during the past 6
    months
  *presence of hypoglycemia unawareness
  *confirmed diagnosis of gastroparesis
  *require the use of drugs that stimulate gastrointestinal motility
  *pediatric patients

Hypoglycemia: SYMLIN alone does not cause hypoglycemia. However, SYMLIN is
indicated to be co-administered with insulin therapy and in this setting
SYMLIN increases the risk of insulin-induced severe hypoglycemia, particularly
in patients with type 1 diabetes. Severe hypoglycemia associated with SYMLIN
occurs within the first 3 hours following a SYMLIN injection. Serious injuries
may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy
machinery, or while engaging in other high-risk activities. Therefore, when
introducing SYMLIN therapy, appropriate precautions need to be taken to avoid
increasing the risk for insulin-induced severe hypoglycemia. These precautions
include frequent pre- and post-meal glucose monitoring combined with an
initial 50% reduction in pre-meal doses of short-acting insulin. The addition
of any antihyperglycemic agent such as SYMLIN to an existing regimen of one or
more antihyperglycemic agents (e.g., insulin, sulfonylurea), or other agents
that can increase the risk of hypoglycemia may necessitate further insulin
dose adjustments; closely monitor blood glucose.

Precautions

Never mix Symlin and insulin: Administer as separate injections. Mixing can
alter the pharmacokinetics of both products.

Allergy: Local allergies such as redness, swelling, or itching at the site of
injection may occur. The incidence of systemic allergic reactions was 5% for
SYMLIN plus insulin vs. 4%-5% for placebo plus insulin.

Drug Interactions: SYMLIN slows gastric emptying. Do not administer with drugs
that alter gastrointestinal motility (e.g., anticholinergic agents such as
atropine) or that slow the intestinal absorption of nutrients (e.g.,
α-glucosidase inhibitors). SYMLIN has the potential to delay the absorption of
concomitantly administered oral medications; if rapid onset is a critical
determinant of effectiveness (such as analgesics), the agent should be
administered at least 1 hour prior to or 2 hours after SYMLIN injection.

Pregnant and Nursing Women: No adequate and well controlled studies have been
conducted in pregnant women. It is unknown whether SYMLIN is excreted in human
milk. SYMLIN should only be used in pregnancy or while nursing if the
potential benefit justifies the potential risk.

Adverse Reactions

Most common adverse events reported in ≥ 5% of patients treated with SYMLIN
plus insulin and with greater incidence than in patients treated with placebo
plus insulin were:

  *Type 2 Diabetes: nausea (28% vs. 12%), headache (13% vs. 7%), anorexia (9%
    vs. 2%), vomiting (8% vs. 4%), abdominal pain (8% vs. 7%), fatigue (7% vs.
    4%), dizziness (6% vs. 4%), coughing (6% vs. 4%), pharyngitis (5% vs. 2%).
  *Type 1 Diabetes: nausea (48% vs. 17%), anorexia (17% vs. 2%), inflicted
    injury (14% vs. 10%), vomiting (11% vs. 7%), arthralgia (7% vs. 5%),
    fatigue (7% vs. 4%), allergic reaction (6% vs. 5%), dizziness (5% vs. 4%).

The incidence for severe hypoglycemic adverse events in placebo-controlled
trials with SYMLIN plus insulin vs. placebo plus insulin and with greater
incidence than in patients treated with placebo plus insulin were:

  *Type 2 Diabetes: Patient-ascertained severe hypoglycemia at 0-3 months
    (8.2% vs. 2.1%) and at >3-6 months (4.7% vs. 2.4%). Medically assisted
    severe hypoglycemia at 0-3 months (1.7% vs. 0.7%).
  *Type 1 Diabetes: Patient-ascertained severe hypoglycemia at 0-3 months
    (16.8% vs. 10.8%) and at >3-6 months (11.1% vs. 8.7%). Medically assisted
    severe hypoglycemia at 0-3 months (7.3% vs. 3.3%) and at >3-6 months (5.2%
    vs. 4.3%).

Please click here for US Full Prescribing Information for Symlin (pramlintide
acetate) 60mcg and 120mcg injection, including Boxed WARNING for severe
hypoglycemia, and click here for the Medication Guide.

About Diabetes

In 2012, diabetes was estimated to affect more than 370 million people
worldwide. The prevalence of diabetes is projected to reach more than 550
million by 2030. Type 1 diabetes is more often diagnosed in children and young
adults and occurs when the body does not produce insulin. Type 2 diabetes
accounts for approximately 90% to 95% of all cases of diagnosed diabetes in
adults. Type 2 diabetes is a chronic disease characterized by insulin
resistance and dysfunction of beta cells in the pancreas, leading to elevated
glucose levels. Over time, this sustained hyperglycemia contributes to further
progression of the disease. Significant unmet needs still exist, as many
patients remain inadequately controlled on their current glucose-lowering
regimen.

AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing
individualized patient care, AstraZeneca and Bristol-Myers Squibb are working
in collaboration to research, develop and commercialize a versatile portfolio
of innovative treatment options for diabetes and related metabolic disorders
that aim to provide treatment effects beyond glucose control. Find out more
about the Alliance and our commitment to meeting the needs of health care
professionals and people with diabetes at www.astrazeneca.com or www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialization of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to
discover, develop and deliver innovative medicines that help patients prevail
over serious diseases. For more information about Bristol-Myers Squibb, visit
www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

AstraZeneca Forward-Looking Statement

The statements contained herein include forward-looking statements. Although
we believe our expectations are based on reasonable assumptions, any
forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual
outcomes and results to be materially different from those predicted. The
forward-looking statements reflect knowledge and information available at the
date of the preparation of this press release and the Company undertakes no
obligation to update these forward-looking statements. Important factors that
could cause actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond our control, include,
among other things, those risk factors identified in the Company's Annual
Report and Form 20-F Information 2011. Nothing contained herein should be
construed as a profit forecast.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995 regarding
product development. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties, including factors
that could delay, divert or change any of them, and could cause actual
outcomes and results to differ materially from current expectations. No
forward-looking statement can be guaranteed. Among other risks, there can be
no guarantee that dapagliflozin will receive regulatory approval in the U.S.
or, if approved, that it will become commercially successful. There is also no
guarantee that the additional studies of currently-approved products described
in this release will lead to additional approved indications for such
products. Forward-looking statements in this press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended
December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current
Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events or otherwise.

Contact:

Media:
Shelly Mittendorf, Bristol-Myers Squibb, 609-252-5799,
shelly.mittendorf@bms.com
Kristin Rogers, AstraZeneca, 302-559-5290, kristin.rogers@astrazeneca.com
or
Investors:
John Elicker, Bristol-Myers Squibb, 609-252-4611, john.elicker@bms.com
Karl Hard, AstraZeneca, 44-20-7604-8123, karl.j.hard@astrazeneca.com
 
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