TRILOGY ACS: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00699998
Collaborator
Daiichi Sankyo Co., Ltd. (Industry), Duke Clinical Research Institute (Other)
9,326
688
2
46
13.6
0.3

Study Details

Study Description

Brief Summary

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
9326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prasugrel

Prasugrel and Low-dose Commercially-available Aspirin

Drug: Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
Other Names:
  • LY640315
  • Effient
  • Efient
  • CS-747
  • Drug: Commercially-available Aspirin
    Low-dose aspirin, oral, as prescribed by physician through end of study

    Active Comparator: Clopidogrel

    Clopidogrel and Low-Dose Commercially-available Aspirin

    Drug: Clopidogrel
    300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

    Drug: Commercially-available Aspirin
    Low-dose aspirin, oral, as prescribed by physician through end of study

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke [Randomization through end of study (30-month visit)]

      The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    Secondary Outcome Measures

    1. Percentage of Participants With a Composite Endpoint of CV Death and MI [Randomization through end of study (30-month visit)]

      The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    2. Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) [Randomization through end of study (30-month visit)]

      The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.

    3. Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke [Randomization through end of study (30-month visit)]

      The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    4. Platelet Aggregation Measures [Day 30 and 12 Months]

      Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.

    5. Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) [Day 30 and 6 Months]

      Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

    6. Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) [Day 30 and Month 6]

      C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.

    7. Genotyping Related to Drug Metabolism [Baseline]

      Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.

    8. Economic and Quality of Life Outcomes [Baseline and follow-up (24 months)]

      Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.

    9. Summary of All Deaths [Randomization through end of study (30-month visit)]

      All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization

    • Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event

    • Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

    Key Exclusion Criteria:
    • Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.

    • Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)

    • Previous or planned PCI or CABG as treatment for the index event

    • PCI/CABG within previous 30 days

    • ST-segment elevation myocardial infarction (STEMI) as the index event

    • Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours

    • History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm

    • History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence

    • Hemodialysis or peritoneal dialysis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham Alabama United States 35233
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Huntsville Alabama United States 35801
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Glendale Arizona United States 85306
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tucson Arizona United States 85724
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Smith Arkansas United States 72917
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anaheim California United States 92801
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Banning California United States 92220
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bellflower California United States 90706
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Healdsburg California United States 95448
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lancaster California United States 93534
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Long Beach California United States 90822
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90027
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mather California United States 95655
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport Beach California United States 92663
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Palo Alto California United States 94304
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sacramento California United States 95817
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California United States 92123
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sylmar California United States 91342
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Yuba City California United States 95991
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Colorado Springs Colorado United States 80909
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Denver Colorado United States 80218
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Loveland Colorado United States 80538
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wheat Ridge Colorado United States 80033
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Washington District of Columbia United States 20422
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Atlantis Florida United States 33462
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aventura Florida United States 33180
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Boynton Beach Florida United States 33472
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brandon Florida United States 33511
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Deerfield Beach Florida United States 33442
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hudson Florida United States 34667
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lakeland Florida United States 33805
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Melbourne Florida United States 32901
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Florida United States 33176
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orlando Florida United States 32803
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ormond Beach Florida United States 32174
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Panama City Florida United States 32401
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pensacola Florida United States 32501
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Port Charlotte Florida United States 33952
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sarasota Florida United States 34232
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tallahassee Florida United States 32308
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tampa Florida United States 33613
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trinity Florida United States 34655
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. West Palm Beach Florida United States 33401
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Atlanta Georgia United States 30342
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Covington Georgia United States 30014
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Decatur Georgia United States 30033
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Riverdale Georgia United States 30274
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Savannah Georgia United States 31405
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Melrose Park Illinois United States 60160
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Peoria Illinois United States 61614
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rock Island Illinois United States 61201
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anderson Indiana United States 46011
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Elkhart Indiana United States 46514
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hammond Indiana United States 46320
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46250
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Muncie Indiana United States 47303
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valparaiso Indiana United States 46383
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ames Iowa United States 50010
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Louisville Kentucky United States 40207
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alexandria Louisiana United States 71301
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baton Rouge Louisiana United States 70808
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Covington Louisiana United States 70433
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lake Charles Louisiana United States 70601
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Natchitoches Louisiana United States 71457
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Orleans Louisiana United States 70112
    66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baltimore Maryland United States 21287
    67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salisbury Maryland United States 21804
    68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Boston Massachusetts United States 02135
    69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fall River Massachusetts United States 02720
    70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bay City Michigan United States 48706
    71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Flint Michigan United States 48532
    72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minneapolis Minnesota United States 55417
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    279 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Xian China 710061
    280 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Xuzhou China 221006
    281 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zhengzhou China 450003
    282 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Armenia-Quindio Colombia
    283 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barranquilla Colombia
    284 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bogota Colombia
    285 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cali Colombia
    286 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Floridablanca Colombia
    287 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Medellin Colombia
    288 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Jose Costa Rica
    289 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dubrovnik Croatia 20000
    290 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Karlovac Croatia 47000
    291 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Koprivnica Croatia 48000
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    293 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rijeka Croatia 51 000
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    295 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Split Croatia 21000
    296 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Varazdin Croatia 42 000
    297 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zadar Croatia 23000
    298 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zagreb Croatia 10000
    299 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Decin Czech Republic 405 99
    300 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frydek-Mistek Czech Republic 738 18
    301 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hradec Kralove Czech Republic 500 05
    302 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Karlovy Vary Czech Republic 360 66
    303 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kromeriz Czech Republic 767 55
    304 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Liberec Czech Republic 460 03
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    306 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pardubice Czech Republic 532 03
    307 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prague Czech Republic 140 21
    308 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zlin Czech Republic 76275
    309 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Copenhagen Denmark 2300
    310 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hellerup Denmark 2900
    311 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kobenhavn Denmark 2400
    312 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alexandria Egypt 21131
    313 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beni Sweif Egypt
    314 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cairo Egypt
    315 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ismailia Egypt
    316 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Menoufiya Egypt
    317 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jyvaskyla Finland 40620
    318 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Angers France 49933
    319 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arras France 62000
    320 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Besancon France 25030
    321 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cambrai France 59407
    322 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chartres Cedex France 28018
    323 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dijon France 21079
    324 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Douai France 59507
    325 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Roche Sur Yon France 85025
    326 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lagny Sur Marne France 77405
    327 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nantes France 44277
    328 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nice France 06002
    329 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Paris France 75015
    330 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pessac France 33604
    331 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poitiers France 86021
    332 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Strasbourg France 67091
    333 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toulouse France 31059
    334 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valenciennes France 59322
    335 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vandoeuvre Les Nancy France 54511
    336 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bad Nauheim Germany 61231
    337 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Darmstadt Germany 64283
    338 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dortmund Germany 44137
    339 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frankfurt Germany 65929
    340 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Halle Germany 06120
    341 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Idar-Oberstein Germany 55743
    342 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Köln Germany 50968
    343 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leipzig Germany 04289
    344 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mainz Germany 55131
    345 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mannheim Germany 68167
    346 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stuttgart Germany 70376
    347 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tuebingen Germany 72076
    348 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Athens Greece 16673
    349 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Haidari/Athens Greece 12462
    350 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kallithea Greece 17674
    351 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Magoula Greece 19600
    352 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Patras Greece 26504
    353 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rhodos Greece 85100
    354 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trikala Greece 42100
    355 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baja Hungary 6500
    356 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bekescsaba Hungary 5601
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    358 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kalocsa Hungary 6300
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    362 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Satoraljaujhely Hungary H-3980
    363 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sopron Hungary 9400
    364 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Szekszard Hungary 7100
    365 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zalaegerszeg Hungary 8900
    366 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ahmedabad India 382 428
    367 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anand India 388325
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    370 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baramati India 413102
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    372 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Calicut India 673004
    373 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chidambaram India 608002
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    375 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coimbatore India 641004
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    377 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guntur India 522001
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    380 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indore India 452018
    381 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jaipur India 302017
    382 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jalandhar India 144008
    383 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kolkata India 700091
    384 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kottayam India 686016
    385 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lucknow India 226003
    386 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madurai India 625020
    387 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mumbai India 400012
    388 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mysore India 570004
    389 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nagpur India 440033
    390 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashik India 422005
    391 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Delhi India 110015
    392 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Patiala India 147001
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    395 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Secunderabad India 500 003
    396 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shivamogga India 577201
    397 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Solapur India 413003
    398 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Surat India 395007
    399 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Thrissur India 680002
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    402 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vadodara India 390015
    403 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vijayawada India 520008
    404 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Visakhapatnam India 530 003
    405 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dublin Ireland
    406 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Galway Ireland
    407 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Afula Israel 18101
    408 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ashkelon Israel 78278
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    416 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rehovot Israel 76100
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    418 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tel Hashomer Israel 52621
    419 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tiberias Israel 15208
    420 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tzfat Israel 13100
    421 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Albano Laziale Italy 00041
    422 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ascoli Piceno Italy 63100
    423 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bari Italy 70124
    424 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bergamo Italy 24128
    425 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brescia Italy 25127
    426 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Caserta Italy 81100
    427 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Forli Italy 47100
    428 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lecco Italy 23900
    429 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Legnago Italy 37045
    430 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Legnano Italy 20025
    431 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Milano Italy 20162
    432 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Novara Italy 28100
    433 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parma Italy 43100
    434 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Perugia Italy 06156
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    436 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Reggio Emilia Italy 42100
    437 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rimini Italy 47900
    438 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rome Italy 00161
    439 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Daniele Del Friuli Italy 33038
    440 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santa Maria Capua Vetere Italy 81055
    441 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saronno Italy 21047
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    444 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trieste Italy 34142
    445 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Busan Korea, Republic of 614-735
    446 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daegu Korea, Republic of 705-718
    447 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daejeon Korea, Republic of 302-718
    448 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gangwon-Do Korea, Republic of 220-701
    449 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gwangju Korea, Republic of 501-757
    450 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Incheon Korea, Republic of 405-760
    451 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jeon Ju-City Korea, Republic of 561-712
    452 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jin-Ju-Si Korea, Republic of 660-702
    453 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of 120-752
    454 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ulsan-Si Korea, Republic of 682-714
    455 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kaunas Lithuania LT-50009
    456 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Klaipeda Lithuania 92288
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    458 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vilnius Lithuania LT-08661
    459 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cheras, Kuala Lumpur Malaysia 56000
    460 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Johor Bahru Malaysia 80100
    461 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kelantan Malaysia 16150
    462 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kuala Lumpur Malaysia 59100
    463 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kuantan Pahang Malaysia 25100
    464 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Perak Malaysia 30990
    465 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sarawak Malaysia 93586
    466 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Selangor Malaysia 43300
    467 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taiping Perak Malaysia 34000
    468 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gozo Malta VCT102
    469 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Msida Malta 2090
    470 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aguascalientes Mexico 20230
    471 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Culiacan Mexico 80270
    472 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durango Mexico 340000
    473 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jalisco Mexico 44210
    474 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leon Mexico 37660
    475 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Monterrey Mexico 64020
    476 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Puebla Mexico 72490
    477 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Queretaro Mexico 76180
    478 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Luis Potosi Mexico 78240
    479 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tijuana Mexico 22500
    480 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alkmaar Netherlands 1815 JD
    481 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Almelo Netherlands 7609 PP
    482 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Amsterdam Netherlands 1091AC
    483 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Apeldoorn Netherlands 7334 DZ
    484 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beverwijk Netherlands 1942 LE
    485 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Blaricum Netherlands 1261 AN
    486 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Delft Netherlands 2625AD
    487 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ede Netherlands 6716 RP
    488 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Eindhoven Netherlands 5623 EJ
    489 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gouda Netherlands 2803 HH
    490 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hoorn Netherlands 1625 HV
    491 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leeuwarden Netherlands 8934 AD
    492 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leiden Netherlands 2334 CK
    493 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leiderdorp Netherlands 2353 GA
    494 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Meppel Netherlands 7943 KA
    495 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oss Netherlands 5342 BT
    496 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Roosendaal Netherlands 4708 AE
    497 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Venlo Netherlands 5912 BL
    498 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Auckland New Zealand 0622
    499 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Christchurch New Zealand 8011
    500 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nelson New Zealand 7010
    501 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wellington New Zealand 6022
    502 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cocle Panama
    503 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. David Panama
    504 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Panama Panama
    505 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arequipa Peru
    506 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Callao Peru
    507 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cuzco Peru
    508 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lima Peru Lima 29
    509 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cagayan De De Oro Philippines 9000
    510 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cavite City Philippines 4114
    511 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Davao City Philippines 8000
    512 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Iloilo City Philippines 5000
    513 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Manila Philippines 1000
    514 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marikina City Philippines
    515 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Metro Manila Philippines 1503
    516 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pasig City Philippines 1605
    517 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Quezon City Philippines 1102
    518 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Quezon City Philippines 1110
    519 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bydgoszcz Poland 85-826
    520 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Elblag Poland 02-300
    521 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gdansk Poland 80-345
    522 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Katowice Poland 40-635
    523 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Koszalin Poland 75-581
    524 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Krakow Poland 31-501
    525 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kutno Poland 99-300
    526 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lodz Poland 94-255
    527 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lubin Poland 59-301
    528 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lublin Poland 20-954
    529 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Myslenice Poland 32-400
    530 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nowy Sacz Poland 33-300
    531 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Olawa Poland 55-200
    532 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Piotrkow Trybunalski Poland 97-300
    533 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pulawy Poland 24-100
    534 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ruda Slaska Poland 41-703
    535 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Skierniewice Poland 96-100
    536 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Szczecin Poland 71-531
    537 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Walbrzych Poland 58-309
    538 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warsaw Poland 04-439
    539 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wejherowo Poland 84-200
    540 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wroclaw Poland 51-124
    541 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aveiro Portugal 3814-501
    542 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Carnaxide Portugal 2790-134
    543 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coimbra Portugal 3000-075
    544 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leiria Portugal 2410-197
    545 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ponta Delgada Portugal 9500-370
    546 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santarem Portugal 2005-177
    547 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Setubal Portugal 2910-446
    548 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vila Franca De Xira Portugal 5000-508
    549 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Caguas Puerto Rico 00725
    550 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mayaguez Puerto Rico 00680
    551 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Juan Puerto Rico 00921-3201
    552 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bacau Romania 600114
    553 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baia Mare Romania 430110
    554 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Braila Romania 810249
    555 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brasov Romania 500326
    556 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bucharest Romania
    557 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Buzau Romania 120144
    558 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cluj-Napoca Romania 400006
    559 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Focsani Romania 620034
    560 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pitesti Romania 110084
    561 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Suceava Romania 7202237
    562 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Targoviste Romania 130083
    563 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arkhangelsk Russian Federation 163045
    564 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gatchina Russian Federation 188300
    565 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kazan Russian Federation 420029
    566 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kemerovo Russian Federation 650002
    567 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Krasnoyarsk Russian Federation 660062
    568 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Moscow Russian Federation 127644
    569 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nizhny Novgorod Russian Federation 603005
    570 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Novokuznetsk Russian Federation 654057
    571 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Novosibirsk Russian Federation 630090
    572 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Omsk Russian Federation 644018
    573 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rostov-On-Don Russian Federation 344068
    574 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Russian Federation 197110
    575 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saratov Russian Federation 410028
    576 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tomsk Russian Federation 634012
    577 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tyumen Russian Federation 625000
    578 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belgrade Serbia 11040
    579 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kragujevac Serbia 34000
    580 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Niska Banja Serbia 18205
    581 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nis Serbia 18000
    582 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zemun Serbia 11080
    583 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Singapore Singapore 119074
    584 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bratislava Slovakia 83348
    585 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Levice Slovakia 934 01
    586 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Martin Slovakia 03601
    587 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nitra Slovakia 95001
    588 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nove Zamky Slovakia 94034
    589 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Presov Slovakia 08181
    590 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ruzomberok Slovakia 03426
    591 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zilina Slovakia 010 01
    592 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alberton South Africa 1449
    593 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bloemfontein South Africa 9301
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    595 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durban South Africa 4071
    596 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. George South Africa 6529
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    598 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parktown West South Africa 2193
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    621 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Udon Thani Thailand 41000
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    623 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Menzel Bourguiba Tunisia 7050
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    626 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sousse Tunisia 4054
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    635 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Isparta Turkey 32100
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    637 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kocaeli Turkey 41380
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    639 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kırıkkale Turkey 71100
    640 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Samsun Turkey 55139
    641 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trabzon Turkey 61080
    642 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cherkasy Ukraine 18009
    643 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dnipropetrovsk Ukraine 49006
    644 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Donetsk Ukraine 83114
    645 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ivano-Frankivsk Ukraine 76018
    646 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kharkiv Ukraine 61176
    647 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kiev Ukraine 02660
    648 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kryvyy Rig Ukraine 50031
    649 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kyiv Ukraine 3115
    650 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lugansk Ukraine 91045
    651 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lutsk Ukraine 43024
    652 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lviv Ukraine 79015
    653 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mykolayiv Ukraine 54003
    654 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Odesa Ukraine 65025
    655 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poltava Ukraine 36038
    656 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Simferopol Ukraine 95026
    657 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vinnytsya Ukraine 21029
    658 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zaporozhye Ukraine 69000
    659 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stockton-On-Tees Cleveland United Kingdom TS19 8PE
    660 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Torquay Cnwll United Kingdom TQ2 7AA
    661 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durham County Durham United Kingdom DH1 5TW
    662 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chesterfield Derbyshire United Kingdom S44 5BL
    663 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plymouth Devon United Kingdom PL6 8DH
    664 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brighton East Sussex United Kingdom BN2 5BE
    665 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cottingham East Yorkshire United Kingdom HU16 5JQ
    666 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Colchester Essex United Kingdom C04 5JL
    667 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Romford Essex United Kingdom RM7 0AG
    668 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. London Greater London United Kingdom SE13 6LH
    669 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Southall Greater London United Kingdom UB1 3HW
    670 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport Gwent United Kingdom NP20 2UB
    671 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portsmouth Hampshire United Kingdom P06 3LY
    672 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orpington Kent United Kingdom BR6 8ND
    673 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lincoln Lincolnshire United Kingdom LN2 5QY
    674 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wirral Merseyside United Kingdom CH49 5PE
    675 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. York North Yorkshire United Kingdom YO31 8HE
    676 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nottingham Nottinghamshire United Kingdom NG5 1PD
    677 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Yeovil Somerset United Kingdom BA21 4AT
    678 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dundee Tays United Kingdom DD1 9SY
    679 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nuneaton Warwickshire United Kingdom CV10 7BL
    680 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warwick Warwickshire United Kingdom CV34 5BW
    681 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Livingston West Lothian United Kingdom EH54 6PP
    682 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham West Midlands United Kingdom B75 7RR
    683 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dudley West Midlands United Kingdom DY1 2HQ
    684 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. West Bromwich West Midlands United Kingdom B71 4HJ
    685 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wolverhampton West Midlands United Kingdom WV10 0QP
    686 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bradford West Yorkshire United Kingdom BD9 6RJ
    687 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Northampton United Kingdom NN1 5BD
    688 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sunderland United Kingdom SR4 7TP

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Daiichi Sankyo Co., Ltd.
    • Duke Clinical Research Institute

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00699998
    Other Study ID Numbers:
    • 11058
    • H7T-MC-TABY(b)
    First Posted:
    Jun 18, 2008
    Last Update Posted:
    May 7, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Period Title: Overall Study
    STARTED 3620 1043 3623 1040
    Received at Least 1 Dose of Study Drug 3590 1033 3590 1027
    COMPLETED 3421 957 3417 958
    NOT COMPLETED 199 86 206 82

    Baseline Characteristics

    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older Total
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Total of all reporting groups
    Overall Participants 3620 1043 3623 1040 9326
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.4
    (8.55)
    80.3
    (4.29)
    61.5
    (8.38)
    80.3
    (4.39)
    65.7
    (11.02)
    Sex: Female, Male (Count of Participants)
    Female
    1309
    36.2%
    520
    49.9%
    1290
    35.6%
    531
    51.1%
    3650
    39.1%
    Male
    2311
    63.8%
    523
    50.1%
    2333
    64.4%
    509
    48.9%
    5676
    60.9%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    2362
    65.2%
    767
    73.5%
    2374
    65.5%
    773
    74.3%
    6276
    67.3%
    African
    87
    2.4%
    14
    1.3%
    72
    2%
    12
    1.2%
    185
    2%
    Hispanic
    321
    8.9%
    109
    10.5%
    346
    9.6%
    86
    8.3%
    862
    9.2%
    Asian
    821
    22.7%
    147
    14.1%
    800
    22.1%
    164
    15.8%
    1932
    20.7%
    Other
    29
    0.8%
    6
    0.6%
    30
    0.8%
    5
    0.5%
    70
    0.8%
    Unknown
    0
    0%
    0
    0%
    1
    0%
    0
    0%
    1
    0%
    Region of Enrollment (participants) [Number]
    Portugal
    18
    0.5%
    11
    1.1%
    14
    0.4%
    11
    1.1%
    54
    0.6%
    Philippines
    58
    1.6%
    7
    0.7%
    48
    1.3%
    14
    1.3%
    127
    1.4%
    Taiwan
    6
    0.2%
    6
    0.6%
    4
    0.1%
    9
    0.9%
    25
    0.3%
    Slovakia
    62
    1.7%
    20
    1.9%
    60
    1.7%
    20
    1.9%
    162
    1.7%
    Greece
    14
    0.4%
    8
    0.8%
    10
    0.3%
    11
    1.1%
    43
    0.5%
    Costa Rica
    5
    0.1%
    1
    0.1%
    2
    0.1%
    2
    0.2%
    10
    0.1%
    Thailand
    30
    0.8%
    17
    1.6%
    36
    1%
    10
    1%
    93
    1%
    Ukraine
    326
    9%
    28
    2.7%
    311
    8.6%
    42
    4%
    707
    7.6%
    Chile
    28
    0.8%
    15
    1.4%
    33
    0.9%
    13
    1.3%
    89
    1%
    Italy
    71
    2%
    44
    4.2%
    70
    1.9%
    47
    4.5%
    232
    2.5%
    India
    513
    14.2%
    56
    5.4%
    508
    14%
    64
    6.2%
    1141
    12.2%
    France
    29
    0.8%
    22
    2.1%
    29
    0.8%
    19
    1.8%
    99
    1.1%
    Denmark
    21
    0.6%
    7
    0.7%
    17
    0.5%
    10
    1%
    55
    0.6%
    Korea, Republic of
    35
    1%
    7
    0.7%
    33
    0.9%
    7
    0.7%
    82
    0.9%
    Panama
    29
    0.8%
    7
    0.7%
    24
    0.7%
    10
    1%
    70
    0.8%
    Turkey
    76
    2.1%
    24
    2.3%
    81
    2.2%
    19
    1.8%
    200
    2.1%
    Czech Republic
    37
    1%
    31
    3%
    32
    0.9%
    38
    3.7%
    138
    1.5%
    Mexico
    38
    1%
    15
    1.4%
    40
    1.1%
    16
    1.5%
    109
    1.2%
    Canada
    58
    1.6%
    14
    1.3%
    61
    1.7%
    13
    1.3%
    146
    1.6%
    Brazil
    154
    4.3%
    27
    2.6%
    147
    4.1%
    34
    3.3%
    362
    3.9%
    Romania
    103
    2.8%
    26
    2.5%
    105
    2.9%
    23
    2.2%
    257
    2.8%
    Croatia
    63
    1.7%
    28
    2.7%
    60
    1.7%
    31
    3%
    182
    2%
    Sweden
    4
    0.1%
    3
    0.3%
    6
    0.2%
    1
    0.1%
    14
    0.2%
    United States
    430
    11.9%
    133
    12.8%
    446
    12.3%
    116
    11.2%
    1125
    12.1%
    Serbia
    42
    1.2%
    4
    0.4%
    40
    1.1%
    5
    0.5%
    91
    1%
    Spain
    13
    0.4%
    8
    0.8%
    10
    0.3%
    12
    1.2%
    43
    0.5%
    Ireland
    5
    0.1%
    4
    0.4%
    6
    0.2%
    3
    0.3%
    18
    0.2%
    Israel
    75
    2.1%
    33
    3.2%
    85
    2.3%
    21
    2%
    214
    2.3%
    Russian Federation
    128
    3.5%
    22
    2.1%
    135
    3.7%
    14
    1.3%
    299
    3.2%
    Colombia
    40
    1.1%
    21
    2%
    45
    1.2%
    17
    1.6%
    123
    1.3%
    Switzerland
    6
    0.2%
    4
    0.4%
    4
    0.1%
    6
    0.6%
    20
    0.2%
    Malaysia
    35
    1%
    7
    0.7%
    33
    0.9%
    9
    0.9%
    84
    0.9%
    Peru
    58
    1.6%
    19
    1.8%
    67
    1.8%
    12
    1.2%
    156
    1.7%
    Australia
    13
    0.4%
    6
    0.6%
    15
    0.4%
    7
    0.7%
    41
    0.4%
    South Africa
    27
    0.7%
    11
    1.1%
    27
    0.7%
    12
    1.2%
    77
    0.8%
    Netherlands
    55
    1.5%
    23
    2.2%
    53
    1.5%
    24
    2.3%
    155
    1.7%
    Tunisia
    20
    0.6%
    3
    0.3%
    20
    0.6%
    4
    0.4%
    47
    0.5%
    China
    126
    3.5%
    38
    3.6%
    120
    3.3%
    44
    4.2%
    328
    3.5%
    Finland
    3
    0.1%
    3
    0.3%
    5
    0.1%
    2
    0.2%
    13
    0.1%
    Lithuania
    29
    0.8%
    8
    0.8%
    32
    0.9%
    4
    0.4%
    73
    0.8%
    Austria
    6
    0.2%
    6
    0.6%
    6
    0.2%
    5
    0.5%
    23
    0.2%
    Malta
    9
    0.2%
    1
    0.1%
    10
    0.3%
    2
    0.2%
    22
    0.2%
    United Kingdom
    33
    0.9%
    21
    2%
    40
    1.1%
    12
    1.2%
    106
    1.1%
    Egypt
    65
    1.8%
    1
    0.1%
    62
    1.7%
    4
    0.4%
    132
    1.4%
    Hungary
    86
    2.4%
    43
    4.1%
    87
    2.4%
    44
    4.2%
    260
    2.8%
    Argentina
    120
    3.3%
    58
    5.6%
    138
    3.8%
    41
    3.9%
    357
    3.8%
    Poland
    137
    3.8%
    59
    5.7%
    129
    3.6%
    68
    6.5%
    393
    4.2%
    Belgium
    7
    0.2%
    7
    0.7%
    7
    0.2%
    8
    0.8%
    29
    0.3%
    Singapore
    2
    0.1%
    5
    0.5%
    5
    0.1%
    1
    0.1%
    13
    0.1%
    Bulgaria
    216
    6%
    48
    4.6%
    209
    5.8%
    55
    5.3%
    528
    5.7%
    Germany
    46
    1.3%
    20
    1.9%
    46
    1.3%
    21
    2%
    133
    1.4%
    New Zealand
    10
    0.3%
    3
    0.3%
    10
    0.3%
    3
    0.3%
    26
    0.3%
    History of Diabetes (participants) [Number]
    Yes
    1393
    38.5%
    363
    34.8%
    1418
    39.1%
    365
    35.1%
    3539
    37.9%
    No
    2221
    61.4%
    678
    65%
    2193
    60.5%
    675
    64.9%
    5767
    61.8%
    Unknown
    6
    0.2%
    2
    0.2%
    12
    0.3%
    0
    0%
    20
    0.2%
    History of Myocardial Infarction (MI) (participants) [Number]
    Yes
    1556
    43%
    426
    40.8%
    1612
    44.5%
    393
    37.8%
    3987
    42.8%
    No
    2035
    56.2%
    603
    57.8%
    1988
    54.9%
    633
    60.9%
    5259
    56.4%
    Unknown
    29
    0.8%
    14
    1.3%
    23
    0.6%
    14
    1.3%
    80
    0.9%
    History of Coronary Revascularization (PCI or CABG) (participants) [Number]
    Yes
    1279
    35.3%
    330
    31.6%
    1365
    37.7%
    299
    28.8%
    3273
    35.1%
    No
    2332
    64.4%
    703
    67.4%
    2239
    61.8%
    734
    70.6%
    6008
    64.4%
    Unknown
    9
    0.2%
    10
    1%
    19
    0.5%
    7
    0.7%
    45
    0.5%
    Clinical Presentation of UA or NSTEMI (participants) [Number]
    Unstable Angina
    963
    26.6%
    166
    15.9%
    981
    27.1%
    192
    18.5%
    2302
    24.7%
    Non-ST-segment Elevation Myocardial Infarction
    2453
    67.8%
    829
    79.5%
    2434
    67.2%
    804
    77.3%
    6520
    69.9%
    Unknown/Did not meet criteria
    204
    5.6%
    48
    4.6%
    208
    5.7%
    44
    4.2%
    504
    5.4%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
    Description The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame Randomization through end of study (30-month visit)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 3620 1043 3623 1040
    Number [percentage of participants with an event]
    10.06
    0.3%
    24.64
    2.4%
    10.96
    0.3%
    24.13
    2.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.210
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.915
    Confidence Interval (2-Sided) 95%
    0.793 to 1.055
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.731
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.029
    Confidence Interval (2-Sided) 95%
    0.865 to 1.225
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    2. Secondary Outcome
    Title Percentage of Participants With a Composite Endpoint of CV Death and MI
    Description The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame Randomization through end of study (30-month visit)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 3620 1043 3623 1040
    Number [percentage of participants with an event]
    9.61
    0.3%
    22.53
    2.2%
    10.21
    0.3%
    22.69
    2.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.388
    Comments
    Method Log Rank
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.940
    Confidence Interval (2-Sided) 95%
    0.812 to 1.088
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.990
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.998
    Confidence Interval (2-Sided) 95%
    0.833 to 1.195
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    3. Secondary Outcome
    Title Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
    Description The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.
    Time Frame Randomization through end of study (30-month visit)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 3620 1043 3623 1040
    Number [percentage of participants with an event]
    12.13
    0.3%
    26.27
    2.5%
    12.83
    0.4%
    25.67
    2.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.353
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.941
    Confidence Interval (2-Sided) 95%
    0.826 to 1.073
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.719
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.029
    Confidence Interval (2-Sided) 95%
    0.869 to 1.218
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    4. Secondary Outcome
    Title Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
    Description The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame Randomization through end of study (30-month visit)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 3620 1043 3623 1040
    Number [percentage of participants with an event]
    10.61
    0.3%
    27.04
    2.6%
    11.12
    0.3%
    26.83
    2.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.270
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.928
    Confidence Interval (2-Sided) 95%
    0.810 to 1.063
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.831
    Comments Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.017
    Confidence Interval (2-Sided) 95%
    0.862 to 1.200
    Parameter Dispersion Type:
    Value:
    Estimation Comments HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.
    5. Secondary Outcome
    Title Platelet Aggregation Measures
    Description Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.
    Time Frame Day 30 and 12 Months

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 720 158 683 179
    Day 30
    93.280
    (3.804)
    151.872
    (8.148)
    193.489
    (3.780)
    200.285
    (8.238)
    Month 12 (n=386, 76, 400, 103)
    94.529
    (5.706)
    135.096
    (14.631)
    199.003
    (5.663)
    181.360
    (14.380)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -100.208
    Confidence Interval (2-Sided) 95%
    -107.872 to -92.545
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated Mean Difference (Final Values) for Day 30 comparison
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -104.475
    Confidence Interval (2-Sided) 95%
    -115.383 to -93.566
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated Mean Difference (Final Values) for 12 month comparison.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -48.413
    Confidence Interval (2-Sided) 95%
    -63.718 to -33.108
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated Mean Difference (Final Values) is for the 30 day comparison.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -46.264
    Confidence Interval (2-Sided) 95%
    -69.061 to -23.468
    Parameter Dispersion Type:
    Value:
    Estimation Comments Estimated Mean Difference (Final Values) is for the 12 month comparison.
    6. Secondary Outcome
    Title Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
    Description Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
    Time Frame Day 30 and 6 Months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 859 196 840 224
    Day 30
    313.494
    (1.039)
    1082.396
    (1.093)
    319.345
    (1.039)
    951.359
    (1.092)
    6 Months (n=725, 125, 701, 174)
    253.434
    (1.049)
    770.132
    (1.135)
    250.982
    (1.049)
    722.750
    (1.130)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.631
    Comments p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 0.982
    Confidence Interval (2-Sided) 95%
    0.910 to 1.059
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 30 day comparison.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.844
    Comments p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.010
    Confidence Interval (2-Sided) 95%
    0.916 to 1.113
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 6 month comparison.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.098
    Comments p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.138
    Confidence Interval (2-Sided) 95%
    0.977 to 1.325
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 30 day comparison.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.545
    Comments p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.066
    Confidence Interval (2-Sided) 95%
    0.867 to 1.310
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 6 month comparison.
    7. Secondary Outcome
    Title Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
    Description C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
    Time Frame Day 30 and Month 6

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 888 209 863 226
    Day 30
    2.330
    (1.053)
    2.441
    (1.150)
    2.287
    (1.053)
    2.226
    (1.150)
    6 Months (n=755, 143, 745, 178)
    2.272
    (1.060)
    1.593
    (1.173)
    2.149
    (1.059)
    1.543
    (1.170)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.727
    Comments p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.018
    Confidence Interval (2-Sided) 95%
    0.919 to 1.129
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 30 day comparison.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Clopidogrel: <75 Years of Age
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.346
    Comments p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.057
    Confidence Interval (2-Sided) 95%
    0.942 to 1.187
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 6 month comparison.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.458
    Comments p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.096
    Confidence Interval (2-Sided) 95%
    0.859 to 1.399
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 30 day comparison.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Prasugrel: 75 Years of Age or Older, Clopidogrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.802
    Comments p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Geometric Ratio Estimate
    Estimated Value 1.033
    Confidence Interval (2-Sided) 95%
    0.803 to 1.329
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric Ratio Estimate is for the 6 month comparison.
    8. Secondary Outcome
    Title Genotyping Related to Drug Metabolism
    Description Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who provided a DNA sample.
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 2210 639 2237 650
    UM, *1/*17
    24.0
    0.7%
    25.0
    2.4%
    25.1
    0.7%
    21.8
    2.1%
    UM, *17/*17
    5.1
    0.1%
    3.6
    0.3%
    5.4
    0.1%
    4.3
    0.4%
    EM (non-UM), *1/*1
    38.8
    1.1%
    42.1
    4%
    35.7
    1%
    41.2
    4%
    IM, *1/*2
    18.6
    0.5%
    18.3
    1.8%
    19.8
    0.5%
    19.7
    1.9%
    IM, *1/*3
    0.8
    0%
    0.6
    0.1%
    0.5
    0%
    0.6
    0.1%
    IM, *1/*4
    0.4
    0%
    0.0
    0%
    0.1
    0%
    0.3
    0%
    IM, *1/*6
    0.0
    0%
    0.2
    0%
    0.0
    0%
    0.2
    0%
    IM, *1/*8
    0.1
    0%
    0.5
    0%
    0.4
    0%
    0.3
    0%
    PM, *2/*2
    3.9
    0.1%
    2.2
    0.2%
    4.3
    0.1%
    3.8
    0.4%
    PM, *2/*3
    0.3
    0%
    0.2
    0%
    0.3
    0%
    0.3
    0%
    PM, *2/*4
    0.0
    0%
    0.2
    0%
    0.2
    0%
    0.2
    0%
    PM, *2/*6
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    PM, *2/*8
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    PM, *3/*3
    0.0
    0%
    0.0
    0%
    0.2
    0%
    0.0
    0%
    UNK, *1/*10
    0.0
    0%
    0.0
    0%
    0.1
    0%
    0.0
    0%
    UNK, *1/*13
    0.0
    0%
    0.2
    0%
    0.0
    0%
    0.0
    0%
    UNK, *1/*9
    0.1
    0%
    0.2
    0%
    0.0
    0%
    0.0
    0%
    UNK, *1/*9, *9/*17
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    UNK, *13/*17
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    UNK, *2/*13
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    UNK, *2/*17
    6.3
    0.2%
    6.1
    0.6%
    6.8
    0.2%
    6.2
    0.6%
    UNK, *2/*9
    0.0
    0%
    0.0
    0%
    0.1
    0%
    0.0
    0%
    UNK, *3/*17
    0.1
    0%
    0.0
    0%
    0.0
    0%
    0.3
    0%
    UNK, *4/*17
    0.2
    0%
    0.2
    0%
    0.2
    0%
    0.0
    0%
    UNK, *4/*9
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    UNK, *6/*17
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.2
    0%
    UNK, *8/*17
    0.2
    0%
    0.0
    0%
    0.1
    0%
    0.0
    0%
    UNK, *9/*17
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    UNK, Undefined genotype
    0.7
    0%
    0.6
    0.1%
    0.5
    0%
    0.6
    0.1%
    9. Secondary Outcome
    Title Economic and Quality of Life Outcomes
    Description Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.
    Time Frame Baseline and follow-up (24 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants (combined <75 years and 75 years and older) with SAQ data.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 1506 1506
    Baseline, physical limitations
    67.8
    (26.1)
    67.0
    (26.5)
    Baseline, angina frequency
    73.6
    (22.9)
    73.1
    (23.5)
    24 Months, physical limitations (n=420, 412)
    75.1
    (24.4)
    74.5
    (25.7)
    24 Months, angina frequency (n=420, 412)
    89.7
    (20.0)
    89.5
    (19.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Prasugrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5
    Comments p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.
    Method ANCOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Prasugrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.72
    Comments p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.
    Method ANCOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Prasugrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.63
    Comments p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.
    Method ANCOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Prasugrel: <75 Years of Age, Prasugrel: 75 Years of Age or Older
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.53
    Comments p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.
    Method ANCOVA
    Comments
    10. Secondary Outcome
    Title Summary of All Deaths
    Description All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.
    Time Frame Randomization through end of study (30-month visit)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Prasugrel: <75 Years of Age Prasugrel: 75 Years of Age or Older Clopidogrel: <75 Years of Age Clopidogrel: 75 Years of Age or Older
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    Measure Participants 3620 1043 3623 1040
    Congestive Heart Failure
    10
    0.3%
    21
    2%
    13
    0.4%
    23
    2.2%
    Cardiogenic Shock
    8
    0.2%
    4
    0.4%
    10
    0.3%
    9
    0.9%
    Cardiac Rupture
    0
    0%
    1
    0.1%
    0
    0%
    0
    0%
    Myocardial Infarction
    16
    0.4%
    24
    2.3%
    24
    0.7%
    21
    2%
    Dysrhythmia
    5
    0.1%
    2
    0.2%
    6
    0.2%
    3
    0.3%
    Stent Thrombosis
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Directly Related to Revascularization-CABG or PCI
    1
    0%
    1
    0.1%
    1
    0%
    1
    0.1%
    Intracranial Hemorrhage
    2
    0.1%
    1
    0.1%
    4
    0.1%
    1
    0.1%
    Non-Hemorrhagic Stroke
    4
    0.1%
    4
    0.4%
    4
    0.1%
    3
    0.3%
    Sudden death due to cardiovascular event
    75
    2.1%
    39
    3.7%
    70
    1.9%
    43
    4.1%
    Pulmonary Embolism
    0
    0%
    1
    0.1%
    2
    0.1%
    1
    0.1%
    Stroke, unknown type
    0
    0%
    1
    0.1%
    0
    0%
    0
    0%
    Other Cardiovascular Event
    6
    0.2%
    1
    0.1%
    0
    0%
    1
    0.1%
    Cardiovascular event, unknown type
    40
    1.1%
    41
    3.9%
    45
    1.2%
    45
    4.3%
    Accidental
    1
    0%
    0
    0%
    1
    0%
    1
    0.1%
    Trauma
    2
    0.1%
    3
    0.3%
    0
    0%
    1
    0.1%
    Hemorrhage, not intracranial
    1
    0%
    1
    0.1%
    0
    0%
    4
    0.4%
    Infection
    14
    0.4%
    21
    2%
    16
    0.4%
    17
    1.6%
    Malignancy
    14
    0.4%
    7
    0.7%
    14
    0.4%
    11
    1.1%
    Suicide
    1
    0%
    0
    0%
    0
    0%
    0
    0%
    Other Non-Cardiovascular event
    8
    0.2%
    4
    0.4%
    8
    0.2%
    6
    0.6%
    Cause unknown (nonadjudicated event)
    0
    0%
    1
    0.1%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
    Arm/Group Title Prasugrel Clopidogrel
    Arm/Group Description Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study. Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
    All Cause Mortality
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1573/4623 (34%) 1594/4617 (34.5%)
    Blood and lymphatic system disorders
    Anaemia 23/4623 (0.5%) 23 23/4617 (0.5%) 23
    Anaemia haemolytic autoimmune 1/4623 (0%) 1 0/4617 (0%) 0
    Autoimmune thrombocytopenia 0/4623 (0%) 0 1/4617 (0%) 1
    Bicytopenia 1/4623 (0%) 1 0/4617 (0%) 0
    Coagulopathy 0/4623 (0%) 0 2/4617 (0%) 2
    Haemorrhagic anaemia 1/4623 (0%) 1 0/4617 (0%) 0
    Hypochromic anaemia 1/4623 (0%) 1 0/4617 (0%) 0
    Iron deficiency anaemia 3/4623 (0.1%) 3 5/4617 (0.1%) 5
    Microcytic anaemia 1/4623 (0%) 1 1/4617 (0%) 1
    Normochromic normocytic anaemia 0/4623 (0%) 0 1/4617 (0%) 1
    Pancytopenia 0/4623 (0%) 0 1/4617 (0%) 1
    Red blood cell abnormality 1/4623 (0%) 1 0/4617 (0%) 0
    Splenic infarction 1/4623 (0%) 1 1/4617 (0%) 1
    Thrombocytopenia 1/4623 (0%) 1 1/4617 (0%) 1
    Cardiac disorders
    Acute coronary syndrome 17/4623 (0.4%) 17 19/4617 (0.4%) 24
    Acute left ventricular failure 8/4623 (0.2%) 11 9/4617 (0.2%) 10
    Acute myocardial infarction 194/4623 (4.2%) 241 194/4617 (4.2%) 244
    Angina pectoris 115/4623 (2.5%) 125 129/4617 (2.8%) 139
    Angina unstable 290/4623 (6.3%) 351 310/4617 (6.7%) 374
    Aortic valve disease 1/4623 (0%) 1 1/4617 (0%) 1
    Aortic valve incompetence 2/4623 (0%) 2 2/4617 (0%) 2
    Aortic valve stenosis 2/4623 (0%) 2 1/4617 (0%) 1
    Arrhythmia 7/4623 (0.2%) 7 2/4617 (0%) 2
    Arrhythmia supraventricular 0/4623 (0%) 0 1/4617 (0%) 1
    Arteriosclerosis coronary artery 4/4623 (0.1%) 4 4/4617 (0.1%) 4
    Arteriospasm coronary 0/4623 (0%) 0 1/4617 (0%) 1
    Atrial fibrillation 82/4623 (1.8%) 88 69/4617 (1.5%) 71
    Atrial flutter 12/4623 (0.3%) 12 4/4617 (0.1%) 5
    Atrial tachycardia 2/4623 (0%) 2 3/4617 (0.1%) 3
    Atrial thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Atrioventricular block 3/4623 (0.1%) 3 6/4617 (0.1%) 7
    Atrioventricular block complete 2/4623 (0%) 2 5/4617 (0.1%) 5
    Atrioventricular block second degree 0/4623 (0%) 0 2/4617 (0%) 2
    Bradyarrhythmia 1/4623 (0%) 1 1/4617 (0%) 1
    Bradycardia 7/4623 (0.2%) 8 14/4617 (0.3%) 14
    Bundle branch block left 1/4623 (0%) 1 0/4617 (0%) 0
    Bundle branch block right 1/4623 (0%) 1 0/4617 (0%) 0
    Cardiac arrest 29/4623 (0.6%) 30 28/4617 (0.6%) 28
    Cardiac disorder 0/4623 (0%) 0 1/4617 (0%) 1
    Cardiac failure 68/4623 (1.5%) 75 67/4617 (1.5%) 81
    Cardiac failure acute 12/4623 (0.3%) 12 19/4617 (0.4%) 19
    Cardiac failure chronic 36/4623 (0.8%) 36 41/4617 (0.9%) 41
    Cardiac failure congestive 83/4623 (1.8%) 96 104/4617 (2.3%) 111
    Cardiac flutter 0/4623 (0%) 0 1/4617 (0%) 1
    Cardiac tamponade 1/4623 (0%) 1 0/4617 (0%) 0
    Cardiac valve disease 1/4623 (0%) 1 0/4617 (0%) 0
    Cardio-respiratory arrest 8/4623 (0.2%) 8 14/4617 (0.3%) 14
    Cardiogenic shock 15/4623 (0.3%) 15 23/4617 (0.5%) 23
    Cardiomegaly 0/4623 (0%) 0 1/4617 (0%) 1
    Cardiomyopathy 3/4623 (0.1%) 3 1/4617 (0%) 1
    Cardiopulmonary failure 5/4623 (0.1%) 5 3/4617 (0.1%) 3
    Cardiovascular insufficiency 0/4623 (0%) 0 1/4617 (0%) 1
    Congestive cardiomyopathy 2/4623 (0%) 2 1/4617 (0%) 2
    Cor pulmonale 0/4623 (0%) 0 1/4617 (0%) 1
    Coronary artery disease 43/4623 (0.9%) 43 39/4617 (0.8%) 39
    Coronary artery dissection 0/4623 (0%) 0 1/4617 (0%) 1
    Coronary artery occlusion 0/4623 (0%) 0 1/4617 (0%) 1
    Coronary artery perforation 0/4623 (0%) 0 1/4617 (0%) 1
    Coronary artery stenosis 8/4623 (0.2%) 8 7/4617 (0.2%) 7
    Coronary artery thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Diastolic dysfunction 1/4623 (0%) 1 0/4617 (0%) 0
    Ischaemic cardiomyopathy 4/4623 (0.1%) 4 3/4617 (0.1%) 3
    Left ventricular dysfunction 1/4623 (0%) 1 2/4617 (0%) 2
    Left ventricular failure 4/4623 (0.1%) 4 8/4617 (0.2%) 8
    Low cardiac output syndrome 1/4623 (0%) 1 0/4617 (0%) 0
    Mitral valve disease 1/4623 (0%) 1 1/4617 (0%) 1
    Mitral valve incompetence 2/4623 (0%) 2 1/4617 (0%) 1
    Myocardial fibrosis 1/4623 (0%) 1 0/4617 (0%) 0
    Myocardial infarction 142/4623 (3.1%) 166 143/4617 (3.1%) 166
    Myocardial ischaemia 31/4623 (0.7%) 31 41/4617 (0.9%) 41
    Palpitations 2/4623 (0%) 2 3/4617 (0.1%) 3
    Pericardial effusion 2/4623 (0%) 2 0/4617 (0%) 0
    Pericarditis 2/4623 (0%) 2 0/4617 (0%) 0
    Postinfarction angina 5/4623 (0.1%) 5 4/4617 (0.1%) 4
    Prinzmetal angina 2/4623 (0%) 2 0/4617 (0%) 0
    Sick sinus syndrome 1/4623 (0%) 1 3/4617 (0.1%) 3
    Sinus arrest 1/4623 (0%) 1 0/4617 (0%) 0
    Sinus bradycardia 2/4623 (0%) 2 1/4617 (0%) 1
    Stress cardiomyopathy 0/4623 (0%) 0 1/4617 (0%) 1
    Supraventricular tachycardia 4/4623 (0.1%) 4 8/4617 (0.2%) 8
    Tachycardia 1/4623 (0%) 1 3/4617 (0.1%) 3
    Ventricle rupture 0/4623 (0%) 0 1/4617 (0%) 1
    Ventricular arrhythmia 4/4623 (0.1%) 4 0/4617 (0%) 0
    Ventricular extrasystoles 2/4623 (0%) 2 5/4617 (0.1%) 5
    Ventricular fibrillation 3/4623 (0.1%) 3 15/4617 (0.3%) 17
    Ventricular tachycardia 15/4623 (0.3%) 17 20/4617 (0.4%) 23
    Congenital, familial and genetic disorders
    Branchial cyst 1/4623 (0%) 1 0/4617 (0%) 0
    Gastrointestinal angiodysplasia 0/4623 (0%) 0 1/4617 (0%) 1
    Glucose-6-phosphate dehydrogenase deficiency 1/4623 (0%) 1 0/4617 (0%) 0
    Hydrocele 1/4623 (0%) 1 0/4617 (0%) 0
    Phimosis 1/4623 (0%) 1 0/4617 (0%) 0
    Ear and labyrinth disorders
    Deafness unilateral 0/4623 (0%) 0 1/4617 (0%) 1
    Vertigo 5/4623 (0.1%) 5 4/4617 (0.1%) 4
    Vertigo positional 1/4623 (0%) 1 2/4617 (0%) 2
    Endocrine disorders
    Goitre 1/4623 (0%) 1 1/4617 (0%) 1
    Hyperthyroidism 1/4623 (0%) 1 0/4617 (0%) 0
    Primary hyperaldosteronism 1/4623 (0%) 1 0/4617 (0%) 0
    Primary hypothyroidism 1/4623 (0%) 1 0/4617 (0%) 0
    Eye disorders
    Amaurosis 0/4623 (0%) 0 1/4617 (0%) 1
    Cataract 8/4623 (0.2%) 9 4/4617 (0.1%) 5
    Conjunctival haemorrhage 1/4623 (0%) 1 1/4617 (0%) 1
    Corneal oedema 0/4623 (0%) 0 1/4617 (0%) 1
    Diabetic retinopathy 0/4623 (0%) 0 1/4617 (0%) 2
    Diplopia 0/4623 (0%) 0 1/4617 (0%) 1
    Eye haemorrhage 1/4623 (0%) 1 1/4617 (0%) 1
    Glaucoma 0/4623 (0%) 0 2/4617 (0%) 2
    Open angle glaucoma 1/4623 (0%) 1 0/4617 (0%) 0
    Ophthalmoplegia 0/4623 (0%) 0 1/4617 (0%) 1
    Retinal artery occlusion 1/4623 (0%) 1 0/4617 (0%) 0
    Retinal detachment 0/4623 (0%) 0 2/4617 (0%) 3
    Retinal haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Retinal vein thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Vision blurred 1/4623 (0%) 1 0/4617 (0%) 0
    Vitreous haemorrhage 1/4623 (0%) 1 2/4617 (0%) 2
    Gastrointestinal disorders
    Abdominal adhesions 0/4623 (0%) 0 1/4617 (0%) 1
    Abdominal hernia 2/4623 (0%) 2 2/4617 (0%) 2
    Abdominal hernia obstructive 1/4623 (0%) 1 0/4617 (0%) 0
    Abdominal pain 6/4623 (0.1%) 6 6/4617 (0.1%) 6
    Abdominal pain lower 1/4623 (0%) 1 0/4617 (0%) 0
    Abdominal pain upper 3/4623 (0.1%) 3 4/4617 (0.1%) 4
    Abdominal wall haematoma 0/4623 (0%) 0 1/4617 (0%) 1
    Acute abdomen 2/4623 (0%) 2 0/4617 (0%) 0
    Anal fissure 0/4623 (0%) 0 1/4617 (0%) 1
    Anal fistula 1/4623 (0%) 1 0/4617 (0%) 0
    Ascites 1/4623 (0%) 1 0/4617 (0%) 0
    Colitis 1/4623 (0%) 1 1/4617 (0%) 1
    Colitis ischaemic 1/4623 (0%) 1 2/4617 (0%) 2
    Colonic polyp 3/4623 (0.1%) 3 2/4617 (0%) 2
    Constipation 2/4623 (0%) 2 3/4617 (0.1%) 3
    Dental caries 0/4623 (0%) 0 1/4617 (0%) 1
    Diarrhoea 1/4623 (0%) 1 4/4617 (0.1%) 4
    Diarrhoea haemorrhagic 1/4623 (0%) 1 0/4617 (0%) 0
    Diverticulum 1/4623 (0%) 1 2/4617 (0%) 2
    Diverticulum intestinal 0/4623 (0%) 0 1/4617 (0%) 1
    Diverticulum intestinal haemorrhagic 0/4623 (0%) 0 1/4617 (0%) 1
    Duodenal polyp 0/4623 (0%) 0 1/4617 (0%) 1
    Duodenal ulcer 6/4623 (0.1%) 6 4/4617 (0.1%) 4
    Duodenal ulcer haemorrhage 4/4623 (0.1%) 4 2/4617 (0%) 2
    Duodenitis 1/4623 (0%) 1 0/4617 (0%) 0
    Dyspepsia 5/4623 (0.1%) 5 2/4617 (0%) 2
    Dysphagia 3/4623 (0.1%) 3 4/4617 (0.1%) 4
    Enteritis 0/4623 (0%) 0 1/4617 (0%) 1
    Epigastric discomfort 0/4623 (0%) 0 1/4617 (0%) 1
    Erosive duodenitis 2/4623 (0%) 2 0/4617 (0%) 0
    Faecaloma 1/4623 (0%) 1 0/4617 (0%) 0
    Femoral hernia 0/4623 (0%) 0 1/4617 (0%) 1
    Gastric disorder 0/4623 (0%) 0 1/4617 (0%) 1
    Gastric haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Gastric ulcer 3/4623 (0.1%) 3 1/4617 (0%) 1
    Gastric ulcer haemorrhage 3/4623 (0.1%) 3 2/4617 (0%) 2
    Gastric ulcer, obstructive 1/4623 (0%) 1 0/4617 (0%) 0
    Gastritis 11/4623 (0.2%) 11 4/4617 (0.1%) 4
    Gastritis erosive 2/4623 (0%) 2 3/4617 (0.1%) 3
    Gastritis haemorrhagic 0/4623 (0%) 0 2/4617 (0%) 2
    Gastrointestinal disorder 2/4623 (0%) 2 1/4617 (0%) 1
    Gastrointestinal haemorrhage 39/4623 (0.8%) 39 22/4617 (0.5%) 22
    Gastrointestinal inflammation 0/4623 (0%) 0 1/4617 (0%) 1
    Gastrointestinal pain 0/4623 (0%) 0 1/4617 (0%) 1
    Gastrointestinal ulcer haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Gastrooesophageal reflux disease 6/4623 (0.1%) 6 3/4617 (0.1%) 3
    Gingival bleeding 1/4623 (0%) 1 1/4617 (0%) 1
    Haematemesis 6/4623 (0.1%) 6 0/4617 (0%) 0
    Haematochezia 2/4623 (0%) 2 2/4617 (0%) 2
    Haemorrhagic erosive gastritis 1/4623 (0%) 1 0/4617 (0%) 0
    Haemorrhoidal haemorrhage 1/4623 (0%) 1 3/4617 (0.1%) 3
    Haemorrhoids 1/4623 (0%) 1 0/4617 (0%) 0
    Hiatus hernia 1/4623 (0%) 1 0/4617 (0%) 0
    Ileus 1/4623 (0%) 1 1/4617 (0%) 1
    Ileus paralytic 1/4623 (0%) 1 1/4617 (0%) 1
    Impaired gastric emptying 0/4623 (0%) 0 1/4617 (0%) 1
    Inguinal hernia 2/4623 (0%) 3 6/4617 (0.1%) 6
    Inguinal hernia strangulated 1/4623 (0%) 1 0/4617 (0%) 0
    Inguinal hernia, obstructive 1/4623 (0%) 1 2/4617 (0%) 2
    Intestinal angina 1/4623 (0%) 1 0/4617 (0%) 0
    Intestinal fistula 0/4623 (0%) 0 1/4617 (0%) 1
    Intestinal haemorrhage 1/4623 (0%) 1 2/4617 (0%) 2
    Intestinal ischaemia 0/4623 (0%) 0 1/4617 (0%) 1
    Intestinal mass 0/4623 (0%) 0 1/4617 (0%) 1
    Intestinal obstruction 1/4623 (0%) 1 3/4617 (0.1%) 3
    Irritable bowel syndrome 0/4623 (0%) 0 1/4617 (0%) 1
    Localised intraabdominal fluid collection 0/4623 (0%) 0 1/4617 (0%) 1
    Lower gastrointestinal haemorrhage 8/4623 (0.2%) 8 3/4617 (0.1%) 3
    Mallory-weiss syndrome 0/4623 (0%) 0 1/4617 (0%) 1
    Melaena 4/4623 (0.1%) 4 1/4617 (0%) 1
    Mesenteric artery embolism 1/4623 (0%) 1 0/4617 (0%) 0
    Nausea 1/4623 (0%) 1 2/4617 (0%) 2
    Oesophageal ulcer 1/4623 (0%) 1 0/4617 (0%) 0
    Oesophageal ulcer haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Oesophagitis 1/4623 (0%) 1 1/4617 (0%) 1
    Palatal oedema 1/4623 (0%) 1 0/4617 (0%) 0
    Pancreatitis 1/4623 (0%) 1 5/4617 (0.1%) 6
    Pancreatitis acute 2/4623 (0%) 2 5/4617 (0.1%) 5
    Pancreatitis chronic 1/4623 (0%) 1 0/4617 (0%) 0
    Pancreatitis haemorrhagic 0/4623 (0%) 0 1/4617 (0%) 1
    Pancreatitis relapsing 0/4623 (0%) 0 1/4617 (0%) 1
    Peptic ulcer 0/4623 (0%) 0 1/4617 (0%) 1
    Rectal haemorrhage 11/4623 (0.2%) 12 4/4617 (0.1%) 4
    Retroperitoneal haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Sigmoiditis 0/4623 (0%) 0 1/4617 (0%) 1
    Small intestinal obstruction 3/4623 (0.1%) 5 3/4617 (0.1%) 4
    Small intestinal perforation 0/4623 (0%) 0 1/4617 (0%) 1
    Subileus 0/4623 (0%) 0 1/4617 (0%) 1
    Umbilical hernia 1/4623 (0%) 1 1/4617 (0%) 1
    Upper gastrointestinal haemorrhage 20/4623 (0.4%) 21 15/4617 (0.3%) 15
    Varices oesophageal 0/4623 (0%) 0 1/4617 (0%) 1
    Vomiting 2/4623 (0%) 2 1/4617 (0%) 1
    General disorders
    Adverse drug reaction 0/4623 (0%) 0 1/4617 (0%) 1
    Asthenia 8/4623 (0.2%) 8 3/4617 (0.1%) 3
    Cardiac death 2/4623 (0%) 2 1/4617 (0%) 1
    Chest discomfort 3/4623 (0.1%) 3 4/4617 (0.1%) 4
    Chest pain 13/4623 (0.3%) 14 5/4617 (0.1%) 6
    Chills 1/4623 (0%) 1 0/4617 (0%) 0
    Death 34/4623 (0.7%) 34 40/4617 (0.9%) 40
    Device malfunction 1/4623 (0%) 1 1/4617 (0%) 1
    Euthanasia 0/4623 (0%) 0 1/4617 (0%) 1
    Generalised oedema 0/4623 (0%) 0 1/4617 (0%) 1
    Hernia 1/4623 (0%) 1 0/4617 (0%) 0
    Impaired healing 0/4623 (0%) 0 1/4617 (0%) 1
    Malaise 2/4623 (0%) 2 0/4617 (0%) 0
    Medical device complication 0/4623 (0%) 0 1/4617 (0%) 1
    Multi-organ failure 3/4623 (0.1%) 3 5/4617 (0.1%) 5
    Necrosis 1/4623 (0%) 1 0/4617 (0%) 0
    Non-cardiac chest pain 66/4623 (1.4%) 71 65/4617 (1.4%) 78
    Oedema peripheral 0/4623 (0%) 0 1/4617 (0%) 1
    Pyrexia 3/4623 (0.1%) 3 3/4617 (0.1%) 3
    Sudden cardiac death 12/4623 (0.3%) 12 16/4617 (0.3%) 16
    Sudden death 45/4623 (1%) 45 46/4617 (1%) 46
    Thrombosis in device 12/4623 (0.3%) 13 23/4617 (0.5%) 24
    Ulcer haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Hepatobiliary disorders
    Bile duct obstruction 1/4623 (0%) 1 0/4617 (0%) 0
    Bile duct stone 0/4623 (0%) 0 1/4617 (0%) 1
    Biliary tract disorder 0/4623 (0%) 0 1/4617 (0%) 1
    Cholecystitis 6/4623 (0.1%) 6 4/4617 (0.1%) 4
    Cholecystitis acute 9/4623 (0.2%) 10 8/4617 (0.2%) 9
    Cholecystitis chronic 1/4623 (0%) 1 3/4617 (0.1%) 3
    Cholelithiasis 4/4623 (0.1%) 4 10/4617 (0.2%) 10
    Cholestasis 0/4623 (0%) 0 1/4617 (0%) 1
    Hepatic cirrhosis 4/4623 (0.1%) 4 0/4617 (0%) 0
    Hepatic failure 0/4623 (0%) 0 1/4617 (0%) 1
    Hepatitis 0/4623 (0%) 0 2/4617 (0%) 2
    Hyperplastic cholecystopathy 1/4623 (0%) 1 0/4617 (0%) 0
    Portal vein thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Immune system disorders
    Atopy 0/4623 (0%) 0 1/4617 (0%) 1
    Drug hypersensitivity 1/4623 (0%) 1 1/4617 (0%) 1
    Hypersensitivity 0/4623 (0%) 0 1/4617 (0%) 1
    Immunosuppression 0/4623 (0%) 0 1/4617 (0%) 1
    Kidney transplant rejection 0/4623 (0%) 0 1/4617 (0%) 2
    Infections and infestations
    Abdominal abscess 1/4623 (0%) 1 0/4617 (0%) 0
    Abdominal sepsis 1/4623 (0%) 1 1/4617 (0%) 1
    Abdominal wall abscess 1/4623 (0%) 1 0/4617 (0%) 0
    Abscess limb 2/4623 (0%) 2 1/4617 (0%) 1
    Abscess neck 0/4623 (0%) 0 1/4617 (0%) 2
    Acute sinusitis 0/4623 (0%) 0 1/4617 (0%) 1
    Anal abscess 1/4623 (0%) 1 2/4617 (0%) 2
    Appendiceal abscess 0/4623 (0%) 0 1/4617 (0%) 1
    Appendicitis 1/4623 (0%) 1 3/4617 (0.1%) 3
    Appendicitis perforated 0/4623 (0%) 0 1/4617 (0%) 1
    Bacteraemia 1/4623 (0%) 1 0/4617 (0%) 0
    Bronchitis 11/4623 (0.2%) 12 15/4617 (0.3%) 15
    Bronchitis bacterial 0/4623 (0%) 0 2/4617 (0%) 2
    Bronchopneumonia 8/4623 (0.2%) 8 8/4617 (0.2%) 10
    Bronchopulmonary aspergillosis 0/4623 (0%) 0 1/4617 (0%) 1
    Burkholderia cepacia complex infection 0/4623 (0%) 0 1/4617 (0%) 1
    Burkholderia pseudomallei infection 0/4623 (0%) 0 1/4617 (0%) 1
    Cellulitis 9/4623 (0.2%) 9 11/4617 (0.2%) 12
    Cholecystitis infective 1/4623 (0%) 1 0/4617 (0%) 0
    Cystitis 1/4623 (0%) 1 1/4617 (0%) 1
    Cytomegalovirus colitis 0/4623 (0%) 0 1/4617 (0%) 1
    Device related infection 2/4623 (0%) 2 0/4617 (0%) 0
    Diabetic gangrene 0/4623 (0%) 0 1/4617 (0%) 1
    Diarrhoea infectious 0/4623 (0%) 0 1/4617 (0%) 1
    Disseminated tuberculosis 0/4623 (0%) 0 1/4617 (0%) 1
    Diverticulitis 3/4623 (0.1%) 3 1/4617 (0%) 1
    Ear infection 1/4623 (0%) 1 0/4617 (0%) 0
    Eczema infected 0/4623 (0%) 0 1/4617 (0%) 1
    Enterocolitis bacterial 0/4623 (0%) 0 1/4617 (0%) 1
    Erysipelas 2/4623 (0%) 2 5/4617 (0.1%) 5
    Escherichia urinary tract infection 0/4623 (0%) 0 1/4617 (0%) 1
    Fungal infection 0/4623 (0%) 0 1/4617 (0%) 1
    Furuncle 1/4623 (0%) 1 0/4617 (0%) 0
    Gangrene 4/4623 (0.1%) 4 1/4617 (0%) 1
    Gastroenteritis 7/4623 (0.2%) 7 7/4617 (0.2%) 7
    Gastroenteritis norovirus 0/4623 (0%) 0 1/4617 (0%) 1
    Gastroenteritis viral 0/4623 (0%) 0 1/4617 (0%) 1
    Gastrointestinal viral infection 1/4623 (0%) 1 0/4617 (0%) 0
    Groin abscess 1/4623 (0%) 1 0/4617 (0%) 0
    Haematoma infection 0/4623 (0%) 0 1/4617 (0%) 1
    Helicobacter gastritis 1/4623 (0%) 1 0/4617 (0%) 0
    Hepatitis b 0/4623 (0%) 0 1/4617 (0%) 1
    Hepatitis c 0/4623 (0%) 0 1/4617 (0%) 1
    Herpes zoster 2/4623 (0%) 2 0/4617 (0%) 0
    Herpes zoster ophthalmic 0/4623 (0%) 0 1/4617 (0%) 1
    Infection 1/4623 (0%) 1 0/4617 (0%) 0
    Infectious peritonitis 1/4623 (0%) 1 1/4617 (0%) 1
    Infective exacerbation of chronic obstructive airways disease 1/4623 (0%) 1 0/4617 (0%) 0
    Labyrinthitis 2/4623 (0%) 2 1/4617 (0%) 1
    Lobar pneumonia 2/4623 (0%) 2 1/4617 (0%) 1
    Localised infection 1/4623 (0%) 1 0/4617 (0%) 0
    Lower respiratory tract infection 0/4623 (0%) 0 1/4617 (0%) 1
    Lower respiratory tract infection viral 0/4623 (0%) 0 1/4617 (0%) 1
    Lung abscess 1/4623 (0%) 1 0/4617 (0%) 0
    Lung infection 0/4623 (0%) 0 2/4617 (0%) 2
    Lymphangitis 1/4623 (0%) 1 0/4617 (0%) 0
    Malaria 2/4623 (0%) 2 0/4617 (0%) 0
    Mediastinitis 0/4623 (0%) 0 1/4617 (0%) 1
    Meningitis tuberculous 1/4623 (0%) 1 0/4617 (0%) 0
    Muscle abscess 1/4623 (0%) 1 0/4617 (0%) 0
    Onychomycosis 0/4623 (0%) 0 1/4617 (0%) 1
    Orchitis 1/4623 (0%) 1 0/4617 (0%) 0
    Osteomyelitis 5/4623 (0.1%) 5 4/4617 (0.1%) 4
    Osteomyelitis chronic 1/4623 (0%) 1 1/4617 (0%) 1
    Parametritis 0/4623 (0%) 0 1/4617 (0%) 1
    Paronychia 1/4623 (0%) 1 0/4617 (0%) 0
    Peridiverticular abscess 2/4623 (0%) 2 0/4617 (0%) 0
    Perirectal abscess 0/4623 (0%) 0 1/4617 (0%) 1
    Pneumonia 74/4623 (1.6%) 86 76/4617 (1.6%) 79
    Pneumonia bacterial 2/4623 (0%) 2 0/4617 (0%) 0
    Pneumonia haemophilus 1/4623 (0%) 1 0/4617 (0%) 0
    Pneumonia mycoplasmal 1/4623 (0%) 1 0/4617 (0%) 0
    Pneumonia staphylococcal 1/4623 (0%) 1 1/4617 (0%) 1
    Pneumonia viral 0/4623 (0%) 0 1/4617 (0%) 1
    Post procedural infection 1/4623 (0%) 1 0/4617 (0%) 0
    Postoperative wound infection 2/4623 (0%) 2 1/4617 (0%) 1
    Pulmonary tuberculosis 1/4623 (0%) 1 1/4617 (0%) 1
    Pyelonephritis 1/4623 (0%) 1 2/4617 (0%) 2
    Pyelonephritis acute 2/4623 (0%) 2 2/4617 (0%) 2
    Pyelonephritis chronic 1/4623 (0%) 1 0/4617 (0%) 0
    Pyonephrosis 1/4623 (0%) 1 0/4617 (0%) 0
    Rectal abscess 0/4623 (0%) 0 1/4617 (0%) 1
    Renal abscess 0/4623 (0%) 0 1/4617 (0%) 1
    Respiratory tract infection 3/4623 (0.1%) 3 7/4617 (0.2%) 7
    Salmonellosis 0/4623 (0%) 0 1/4617 (0%) 1
    Scrotal abscess 0/4623 (0%) 0 1/4617 (0%) 1
    Sepsis 11/4623 (0.2%) 11 12/4617 (0.3%) 12
    Septic shock 6/4623 (0.1%) 6 8/4617 (0.2%) 8
    Sinusitis 1/4623 (0%) 1 0/4617 (0%) 0
    Skin infection 0/4623 (0%) 0 1/4617 (0%) 1
    Staphylococcal bacteraemia 1/4623 (0%) 1 1/4617 (0%) 1
    Staphylococcal infection 0/4623 (0%) 0 1/4617 (0%) 1
    Staphylococcal sepsis 1/4623 (0%) 1 0/4617 (0%) 0
    Subcutaneous abscess 2/4623 (0%) 2 0/4617 (0%) 0
    Tracheobronchitis 2/4623 (0%) 2 2/4617 (0%) 2
    Tuberculosis 1/4623 (0%) 1 0/4617 (0%) 0
    Upper respiratory tract infection 2/4623 (0%) 2 2/4617 (0%) 2
    Urinary tract infection 33/4623 (0.7%) 34 19/4617 (0.4%) 20
    Urosepsis 4/4623 (0.1%) 4 3/4617 (0.1%) 3
    Viral diarrhoea 0/4623 (0%) 0 1/4617 (0%) 1
    Viral infection 0/4623 (0%) 0 1/4617 (0%) 1
    Viral upper respiratory tract infection 1/4623 (0%) 1 0/4617 (0%) 0
    Wound infection 1/4623 (0%) 1 2/4617 (0%) 2
    Injury, poisoning and procedural complications
    Accidental overdose 0/4623 (0%) 0 1/4617 (0%) 1
    Alcohol poisoning 0/4623 (0%) 0 1/4617 (0%) 1
    Ankle fracture 2/4623 (0%) 2 4/4617 (0.1%) 4
    Arteriovenous fistula site haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Brain contusion 1/4623 (0%) 1 0/4617 (0%) 0
    Chemical burns of eye 1/4623 (0%) 1 0/4617 (0%) 0
    Concussion 0/4623 (0%) 0 1/4617 (0%) 1
    Confusion postoperative 0/4623 (0%) 0 1/4617 (0%) 1
    Contusion 1/4623 (0%) 1 3/4617 (0.1%) 3
    Coronary artery restenosis 0/4623 (0%) 0 1/4617 (0%) 1
    Face injury 1/4623 (0%) 1 0/4617 (0%) 0
    Facial bones fracture 1/4623 (0%) 1 0/4617 (0%) 0
    Fall 5/4623 (0.1%) 5 1/4617 (0%) 1
    Femoral neck fracture 1/4623 (0%) 1 3/4617 (0.1%) 3
    Femur fracture 7/4623 (0.2%) 7 7/4617 (0.2%) 7
    Fibula fracture 0/4623 (0%) 0 2/4617 (0%) 2
    Foot fracture 0/4623 (0%) 0 1/4617 (0%) 1
    Gun shot wound 1/4623 (0%) 1 2/4617 (0%) 2
    Haematuria traumatic 1/4623 (0%) 1 0/4617 (0%) 0
    Hand fracture 2/4623 (0%) 2 1/4617 (0%) 1
    Head injury 2/4623 (0%) 2 1/4617 (0%) 1
    Hip fracture 6/4623 (0.1%) 6 6/4617 (0.1%) 6
    Humerus fracture 1/4623 (0%) 1 1/4617 (0%) 1
    In-stent coronary artery restenosis 3/4623 (0.1%) 3 7/4617 (0.2%) 7
    Incisional hernia, obstructive 0/4623 (0%) 0 1/4617 (0%) 1
    Joint dislocation 1/4623 (0%) 1 1/4617 (0%) 1
    Limb injury 0/4623 (0%) 0 1/4617 (0%) 1
    Lower limb fracture 1/4623 (0%) 1 0/4617 (0%) 0
    Lumbar vertebral fracture 0/4623 (0%) 0 1/4617 (0%) 1
    Multiple drug overdose 0/4623 (0%) 0 1/4617 (0%) 1
    Muscle rupture 0/4623 (0%) 0 1/4617 (0%) 1
    Operative haemorrhage 0/4623 (0%) 0 2/4617 (0%) 2
    Overdose 0/4623 (0%) 0 1/4617 (0%) 1
    Pelvic fracture 1/4623 (0%) 1 1/4617 (0%) 1
    Periorbital haematoma 1/4623 (0%) 1 0/4617 (0%) 0
    Periorbital haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Poisoning 0/4623 (0%) 0 1/4617 (0%) 1
    Post procedural haematoma 1/4623 (0%) 1 0/4617 (0%) 0
    Post procedural haemorrhage 5/4623 (0.1%) 5 4/4617 (0.1%) 4
    Post procedural myocardial infarction 0/4623 (0%) 0 1/4617 (0%) 1
    Postoperative fever 1/4623 (0%) 1 0/4617 (0%) 0
    Postoperative thrombosis 1/4623 (0%) 1 0/4617 (0%) 0
    Postoperative wound complication 0/4623 (0%) 0 1/4617 (0%) 1
    Pubis fracture 0/4623 (0%) 0 1/4617 (0%) 1
    Rib fracture 3/4623 (0.1%) 3 2/4617 (0%) 2
    Road traffic accident 4/4623 (0.1%) 4 1/4617 (0%) 1
    Scapula fracture 1/4623 (0%) 1 0/4617 (0%) 0
    Skeletal injury 1/4623 (0%) 1 0/4617 (0%) 0
    Skull fractured base 1/4623 (0%) 1 0/4617 (0%) 0
    Soft tissue injury 1/4623 (0%) 1 0/4617 (0%) 0
    Spinal column injury 0/4623 (0%) 0 1/4617 (0%) 1
    Spinal compression fracture 0/4623 (0%) 0 2/4617 (0%) 2
    Spinal fracture 1/4623 (0%) 1 0/4617 (0%) 0
    Splenic rupture 0/4623 (0%) 0 2/4617 (0%) 2
    Stab wound 1/4623 (0%) 1 0/4617 (0%) 0
    Sternal fracture 0/4623 (0%) 0 1/4617 (0%) 1
    Subcutaneous haematoma 0/4623 (0%) 0 1/4617 (0%) 1
    Subdural haematoma 7/4623 (0.2%) 8 7/4617 (0.2%) 7
    Subdural haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Tendon rupture 0/4623 (0%) 0 1/4617 (0%) 1
    Thermal burn 1/4623 (0%) 1 3/4617 (0.1%) 3
    Tibia fracture 1/4623 (0%) 1 2/4617 (0%) 2
    Tooth fracture 0/4623 (0%) 0 1/4617 (0%) 1
    Toxicity to various agents 1/4623 (0%) 1 0/4617 (0%) 0
    Traumatic haematoma 0/4623 (0%) 0 1/4617 (0%) 1
    Traumatic intracranial haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Vascular graft occlusion 0/4623 (0%) 0 1/4617 (0%) 1
    Vascular pseudoaneurysm 3/4623 (0.1%) 3 2/4617 (0%) 2
    Weaning failure 1/4623 (0%) 1 0/4617 (0%) 0
    Wound 2/4623 (0%) 2 0/4617 (0%) 0
    Wound dehiscence 0/4623 (0%) 0 1/4617 (0%) 1
    Wound haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Wound secretion 0/4623 (0%) 0 1/4617 (0%) 1
    Investigations
    Acinetobacter test positive 0/4623 (0%) 0 1/4617 (0%) 1
    Alanine aminotransferase increased 0/4623 (0%) 0 1/4617 (0%) 1
    Angiogram 1/4623 (0%) 1 0/4617 (0%) 0
    Aspartate aminotransferase increased 0/4623 (0%) 0 1/4617 (0%) 1
    Blood glucose fluctuation 1/4623 (0%) 1 0/4617 (0%) 0
    Blood glucose increased 2/4623 (0%) 2 0/4617 (0%) 0
    Blood pressure increased 0/4623 (0%) 0 1/4617 (0%) 1
    Catheterisation cardiac 1/4623 (0%) 1 0/4617 (0%) 0
    Coagulation time prolonged 1/4623 (0%) 1 0/4617 (0%) 0
    Ejection fraction decreased 1/4623 (0%) 1 0/4617 (0%) 0
    Electrocardiogram qt prolonged 1/4623 (0%) 1 0/4617 (0%) 0
    Electrocardiogram st segment elevation 1/4623 (0%) 1 0/4617 (0%) 0
    Haematocrit decreased 1/4623 (0%) 1 0/4617 (0%) 0
    Haemoglobin decreased 2/4623 (0%) 2 1/4617 (0%) 1
    Hepatic enzyme increased 0/4623 (0%) 0 1/4617 (0%) 1
    Occult blood 1/4623 (0%) 1 1/4617 (0%) 1
    Prostatic specific antigen increased 1/4623 (0%) 1 0/4617 (0%) 0
    Metabolism and nutrition disorders
    Acidosis 1/4623 (0%) 1 0/4617 (0%) 0
    Cachexia 1/4623 (0%) 1 0/4617 (0%) 0
    Dehydration 4/4623 (0.1%) 4 5/4617 (0.1%) 5
    Diabetes mellitus 13/4623 (0.3%) 13 9/4617 (0.2%) 9
    Diabetes mellitus inadequate control 0/4623 (0%) 0 1/4617 (0%) 1
    Diabetic foot 5/4623 (0.1%) 5 3/4617 (0.1%) 3
    Diabetic ketoacidosis 3/4623 (0.1%) 4 5/4617 (0.1%) 5
    Electrolyte imbalance 1/4623 (0%) 1 0/4617 (0%) 0
    Failure to thrive 1/4623 (0%) 1 1/4617 (0%) 1
    Fluid overload 2/4623 (0%) 2 0/4617 (0%) 0
    Gout 1/4623 (0%) 1 1/4617 (0%) 1
    Hyperglycaemia 6/4623 (0.1%) 7 5/4617 (0.1%) 6
    Hyperkalaemia 3/4623 (0.1%) 3 8/4617 (0.2%) 8
    Hypoglycaemia 10/4623 (0.2%) 11 13/4617 (0.3%) 14
    Hypokalaemia 1/4623 (0%) 1 3/4617 (0.1%) 3
    Hyponatraemia 6/4623 (0.1%) 6 4/4617 (0.1%) 4
    Hypovolaemia 0/4623 (0%) 0 1/4617 (0%) 1
    Metabolic acidosis 0/4623 (0%) 0 1/4617 (0%) 1
    Obesity 1/4623 (0%) 1 0/4617 (0%) 0
    Shock hypoglycaemic 1/4623 (0%) 1 1/4617 (0%) 1
    Type 2 diabetes mellitus 0/4623 (0%) 0 2/4617 (0%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/4623 (0%) 0 1/4617 (0%) 1
    Arthritis 0/4623 (0%) 0 2/4617 (0%) 2
    Back pain 5/4623 (0.1%) 5 5/4617 (0.1%) 5
    Bursitis 0/4623 (0%) 0 1/4617 (0%) 1
    Cervical spinal stenosis 1/4623 (0%) 1 1/4617 (0%) 1
    Costochondritis 2/4623 (0%) 2 4/4617 (0.1%) 4
    Dupuytren's contracture 1/4623 (0%) 1 0/4617 (0%) 0
    Gouty arthritis 1/4623 (0%) 1 2/4617 (0%) 2
    Haemarthrosis 0/4623 (0%) 0 1/4617 (0%) 1
    Intervertebral disc degeneration 1/4623 (0%) 1 0/4617 (0%) 0
    Intervertebral disc disorder 2/4623 (0%) 2 0/4617 (0%) 0
    Intervertebral disc protrusion 5/4623 (0.1%) 5 2/4617 (0%) 3
    Joint effusion 0/4623 (0%) 0 1/4617 (0%) 1
    Musculoskeletal chest pain 5/4623 (0.1%) 5 5/4617 (0.1%) 5
    Musculoskeletal pain 5/4623 (0.1%) 5 1/4617 (0%) 1
    Myalgia 1/4623 (0%) 1 0/4617 (0%) 0
    Myopathy 1/4623 (0%) 1 0/4617 (0%) 0
    Osteoarthritis 6/4623 (0.1%) 6 11/4617 (0.2%) 11
    Osteochondritis 1/4623 (0%) 1 1/4617 (0%) 1
    Osteoporosis 0/4623 (0%) 0 1/4617 (0%) 1
    Pain in extremity 1/4623 (0%) 1 1/4617 (0%) 1
    Periarthritis 1/4623 (0%) 1 0/4617 (0%) 0
    Psoriatic arthropathy 0/4623 (0%) 0 1/4617 (0%) 1
    Rhabdomyolysis 1/4623 (0%) 1 2/4617 (0%) 2
    Rheumatoid arthritis 2/4623 (0%) 2 1/4617 (0%) 1
    Spinal column stenosis 0/4623 (0%) 0 1/4617 (0%) 1
    Spinal osteoarthritis 1/4623 (0%) 1 4/4617 (0.1%) 4
    Spondylitis 0/4623 (0%) 0 1/4617 (0%) 1
    Synovial cyst 1/4623 (0%) 1 0/4617 (0%) 0
    Synovitis 1/4623 (0%) 1 0/4617 (0%) 0
    Tenosynovitis 1/4623 (0%) 1 0/4617 (0%) 0
    Vertebral foraminal stenosis 0/4623 (0%) 0 1/4617 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign laryngeal neoplasm 1/4623 (0%) 1 0/4617 (0%) 0
    Benign ovarian tumour 1/4623 (0%) 1 0/4617 (0%) 0
    Benign renal neoplasm 1/4623 (0%) 1 0/4617 (0%) 0
    Benign small intestinal neoplasm 1/4623 (0%) 1 0/4617 (0%) 0
    Colon adenoma 0/4623 (0%) 0 1/4617 (0%) 1
    Lipoma 1/4623 (0%) 1 0/4617 (0%) 0
    Phaeochromocytoma 1/4623 (0%) 1 0/4617 (0%) 0
    Prostatic adenoma 0/4623 (0%) 0 1/4617 (0%) 1
    Uterine leiomyoma 2/4623 (0%) 2 2/4617 (0%) 2
    Nervous system disorders
    Aphasia 1/4623 (0%) 1 1/4617 (0%) 1
    Autonomic neuropathy 0/4623 (0%) 0 1/4617 (0%) 1
    Basal ganglia haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Brain oedema 1/4623 (0%) 1 1/4617 (0%) 1
    Brain stem stroke 1/4623 (0%) 1 1/4617 (0%) 1
    Carotid arteriosclerosis 0/4623 (0%) 0 1/4617 (0%) 1
    Carotid artery aneurysm 1/4623 (0%) 1 0/4617 (0%) 0
    Carotid artery disease 0/4623 (0%) 0 2/4617 (0%) 2
    Carotid artery occlusion 2/4623 (0%) 2 0/4617 (0%) 0
    Carotid artery stenosis 4/4623 (0.1%) 4 6/4617 (0.1%) 6
    Carotid sinus syndrome 1/4623 (0%) 1 0/4617 (0%) 0
    Cerebellar infarction 0/4623 (0%) 0 1/4617 (0%) 1
    Cerebral haematoma 0/4623 (0%) 0 2/4617 (0%) 2
    Cerebral haemorrhage 0/4623 (0%) 0 1/4617 (0%) 1
    Cerebral hypoperfusion 1/4623 (0%) 1 0/4617 (0%) 0
    Cerebral infarction 5/4623 (0.1%) 5 3/4617 (0.1%) 3
    Cerebrovascular accident 33/4623 (0.7%) 34 19/4617 (0.4%) 19
    Cervical root pain 0/4623 (0%) 0 1/4617 (0%) 1
    Cervicobrachial syndrome 0/4623 (0%) 0 2/4617 (0%) 2
    Cluster headache 1/4623 (0%) 1 0/4617 (0%) 0
    Coma 1/4623 (0%) 1 0/4617 (0%) 0
    Convulsion 3/4623 (0.1%) 3 2/4617 (0%) 2
    Diabetic neuropathy 0/4623 (0%) 0 3/4617 (0.1%) 3
    Dizziness 5/4623 (0.1%) 5 5/4617 (0.1%) 5
    Encephalopathy 2/4623 (0%) 3 2/4617 (0%) 2
    Epilepsy 2/4623 (0%) 2 0/4617 (0%) 0
    Grand mal convulsion 0/4623 (0%) 0 1/4617 (0%) 1
    Haemorrhage intracranial 0/4623 (0%) 0 1/4617 (0%) 1
    Haemorrhagic stroke 3/4623 (0.1%) 3 5/4617 (0.1%) 5
    Headache 1/4623 (0%) 1 2/4617 (0%) 2
    Hemiparesis 1/4623 (0%) 1 0/4617 (0%) 0
    Hydrocephalus 0/4623 (0%) 0 1/4617 (0%) 1
    Hypoaesthesia 1/4623 (0%) 1 0/4617 (0%) 0
    Hypoxic-ischaemic encephalopathy 1/4623 (0%) 1 3/4617 (0.1%) 3
    Iiird nerve paresis 0/4623 (0%) 0 1/4617 (0%) 1
    Intracranial aneurysm 2/4623 (0%) 2 0/4617 (0%) 0
    Intracranial hypotension 1/4623 (0%) 1 0/4617 (0%) 0
    Ischaemic cerebral infarction 0/4623 (0%) 0 1/4617 (0%) 1
    Ischaemic stroke 24/4623 (0.5%) 24 30/4617 (0.6%) 31
    Lacunar infarction 1/4623 (0%) 1 1/4617 (0%) 1
    Metabolic encephalopathy 0/4623 (0%) 0 1/4617 (0%) 1
    Migraine 2/4623 (0%) 2 0/4617 (0%) 0
    Neuralgia 0/4623 (0%) 0 1/4617 (0%) 1
    Normal pressure hydrocephalus 1/4623 (0%) 1 0/4617 (0%) 0
    Occipital neuralgia 0/4623 (0%) 0 1/4617 (0%) 1
    Paraesthesia 0/4623 (0%) 0 1/4617 (0%) 1
    Partial seizures 1/4623 (0%) 1 0/4617 (0%) 0
    Pneumocephalus 1/4623 (0%) 1 0/4617 (0%) 0
    Polyneuropathy 1/4623 (0%) 1 0/4617 (0%) 0
    Post-traumatic epilepsy 0/4623 (0%) 0 1/4617 (0%) 1
    Presyncope 5/4623 (0.1%) 5 9/4617 (0.2%) 9
    Radiculitis lumbosacral 0/4623 (0%) 0 1/4617 (0%) 1
    Sciatica 0/4623 (0%) 0 1/4617 (0%) 1
    Spinal cord herniation 1/4623 (0%) 1 0/4617 (0%) 0
    Spinal cord infarction 0/4623 (0%) 0 1/4617 (0%) 1
    Subarachnoid haemorrhage 4/4623 (0.1%) 4 2/4617 (0%) 2
    Syncope 28/4623 (0.6%) 30 27/4617 (0.6%) 29
    Transient ischaemic attack 9/4623 (0.2%) 9 11/4617 (0.2%) 12
    Tremor 1/4623 (0%) 1 0/4617 (0%) 0
    Vertebrobasilar insufficiency 0/4623 (0%) 0 1/4617 (0%) 1
    Viith nerve paralysis 1/4623 (0%) 1 0/4617 (0%) 0
    Psychiatric disorders
    Abnormal behaviour 1/4623 (0%) 1 0/4617 (0%) 0
    Affective disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Agitation 1/4623 (0%) 1 0/4617 (0%) 0
    Alcohol abuse 1/4623 (0%) 1 0/4617 (0%) 0
    Anxiety 2/4623 (0%) 2 2/4617 (0%) 2
    Anxiety disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Bipolar disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Confusional state 1/4623 (0%) 1 1/4617 (0%) 1
    Delirium 1/4623 (0%) 1 1/4617 (0%) 1
    Depression 7/4623 (0.2%) 7 2/4617 (0%) 2
    Mental disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Mental status changes 4/4623 (0.1%) 4 3/4617 (0.1%) 3
    Panic attack 1/4623 (0%) 1 1/4617 (0%) 2
    Psychosomatic disease 1/4623 (0%) 1 0/4617 (0%) 0
    Psychotic disorder due to a general medical condition 0/4623 (0%) 0 1/4617 (0%) 1
    Suicidal ideation 1/4623 (0%) 1 1/4617 (0%) 1
    Suicide attempt 2/4623 (0%) 2 2/4617 (0%) 2
    Renal and urinary disorders
    Acute prerenal failure 2/4623 (0%) 2 1/4617 (0%) 1
    Bladder outlet obstruction 0/4623 (0%) 0 1/4617 (0%) 1
    Calculus bladder 1/4623 (0%) 1 0/4617 (0%) 0
    Calculus ureteric 4/4623 (0.1%) 4 4/4617 (0.1%) 4
    Calculus urinary 3/4623 (0.1%) 3 0/4617 (0%) 0
    Diabetic nephropathy 3/4623 (0.1%) 3 3/4617 (0.1%) 3
    Haematuria 10/4623 (0.2%) 10 10/4617 (0.2%) 11
    Haemorrhage urinary tract 1/4623 (0%) 1 0/4617 (0%) 0
    Hydronephrosis 1/4623 (0%) 1 0/4617 (0%) 0
    Mesangioproliferative glomerulonephritis 0/4623 (0%) 0 1/4617 (0%) 1
    Nephrolithiasis 1/4623 (0%) 2 3/4617 (0.1%) 3
    Nephropathy toxic 1/4623 (0%) 1 1/4617 (0%) 1
    Nephrotic syndrome 0/4623 (0%) 0 1/4617 (0%) 1
    Pyelocaliectasis 1/4623 (0%) 1 0/4617 (0%) 0
    Renal artery stenosis 1/4623 (0%) 1 0/4617 (0%) 0
    Renal colic 1/4623 (0%) 1 1/4617 (0%) 1
    Renal failure 12/4623 (0.3%) 12 7/4617 (0.2%) 7
    Renal failure acute 21/4623 (0.5%) 22 20/4617 (0.4%) 21
    Renal failure chronic 9/4623 (0.2%) 9 9/4617 (0.2%) 9
    Renal impairment 0/4623 (0%) 0 3/4617 (0.1%) 3
    Renal injury 0/4623 (0%) 0 1/4617 (0%) 1
    Ureteric stenosis 1/4623 (0%) 1 0/4617 (0%) 0
    Urethral stenosis 1/4623 (0%) 1 0/4617 (0%) 0
    Urinary hesitation 0/4623 (0%) 0 2/4617 (0%) 2
    Urinary retention 1/4623 (0%) 1 2/4617 (0%) 2
    Urinary tract inflammation 0/4623 (0%) 0 1/4617 (0%) 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 4/4623 (0.1%) 4 3/4617 (0.1%) 3
    Breast haematoma 1/4623 (0%) 1 0/4617 (0%) 0
    Cervical dysplasia 0/4623 (0%) 0 1/4617 (0%) 1
    Endometrial hyperplasia 1/4623 (0%) 1 0/4617 (0%) 0
    Epididymitis 1/4623 (0%) 1 0/4617 (0%) 0
    Menorrhagia 0/4623 (0%) 0 1/4617 (0%) 1
    Ovarian cyst 1/4623 (0%) 1 0/4617 (0%) 0
    Pelvic haematoma 1/4623 (0%) 1 0/4617 (0%) 0
    Prostatitis 1/4623 (0%) 1 0/4617 (0%) 0
    Sexual dysfunction 0/4623 (0%) 0 1/4617 (0%) 1
    Uterine prolapse 1/4623 (0%) 1 0/4617 (0%) 0
    Vaginal haemorrhage 3/4623 (0.1%) 3 2/4617 (0%) 3
    Vaginal prolapse 0/4623 (0%) 0 2/4617 (0%) 2
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 14/4623 (0.3%) 18 23/4617 (0.5%) 27
    Acute respiratory distress syndrome 0/4623 (0%) 0 1/4617 (0%) 1
    Acute respiratory failure 7/4623 (0.2%) 8 11/4617 (0.2%) 13
    Alveolitis allergic 0/4623 (0%) 0 1/4617 (0%) 1
    Asthma 7/4623 (0.2%) 7 3/4617 (0.1%) 3
    Bronchiectasis 1/4623 (0%) 1 1/4617 (0%) 3
    Bronchitis chronic 3/4623 (0.1%) 3 2/4617 (0%) 2
    Bronchospasm 2/4623 (0%) 2 1/4617 (0%) 1
    Choking 0/4623 (0%) 0 1/4617 (0%) 1
    Chronic obstructive pulmonary disease 26/4623 (0.6%) 26 31/4617 (0.7%) 32
    Cough 1/4623 (0%) 1 1/4617 (0%) 2
    Dyspnoea 10/4623 (0.2%) 12 9/4617 (0.2%) 9
    Dyspnoea exertional 0/4623 (0%) 0 1/4617 (0%) 1
    Emphysema 1/4623 (0%) 1 0/4617 (0%) 0
    Epistaxis 11/4623 (0.2%) 11 9/4617 (0.2%) 9
    Haemoptysis 4/4623 (0.1%) 4 2/4617 (0%) 2
    Haemothorax 1/4623 (0%) 1 0/4617 (0%) 0
    Hyperventilation 0/4623 (0%) 0 1/4617 (0%) 1
    Hypoxia 1/4623 (0%) 1 0/4617 (0%) 0
    Interstitial lung disease 1/4623 (0%) 1 0/4617 (0%) 0
    Lung disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Nasal obstruction 0/4623 (0%) 0 1/4617 (0%) 1
    Nasal polyps 0/4623 (0%) 0 1/4617 (0%) 1
    Nocturnal dyspnoea 0/4623 (0%) 0 1/4617 (0%) 1
    Obstructive airways disorder 1/4623 (0%) 1 0/4617 (0%) 0
    Occupational asthma 1/4623 (0%) 1 0/4617 (0%) 0
    Organising pneumonia 0/4623 (0%) 0 1/4617 (0%) 1
    Pleural effusion 3/4623 (0.1%) 3 8/4617 (0.2%) 8
    Pleuritic pain 0/4623 (0%) 0 2/4617 (0%) 2
    Pneumonia aspiration 3/4623 (0.1%) 3 0/4617 (0%) 0
    Pneumonitis 2/4623 (0%) 2 1/4617 (0%) 1
    Pneumothorax 0/4623 (0%) 0 1/4617 (0%) 1
    Pulmonary congestion 1/4623 (0%) 1 1/4617 (0%) 1
    Pulmonary embolism 12/4623 (0.3%) 12 11/4617 (0.2%) 11
    Pulmonary fibrosis 1/4623 (0%) 1 0/4617 (0%) 0
    Pulmonary haemorrhage 1/4623 (0%) 1 1/4617 (0%) 1
    Pulmonary hypertension 0/4623 (0%) 0 1/4617 (0%) 1
    Pulmonary infarction 1/4623 (0%) 1 0/4617 (0%) 0
    Pulmonary oedema 15/4623 (0.3%) 15 16/4617 (0.3%) 19
    Respiratory arrest 1/4623 (0%) 1 1/4617 (0%) 1
    Respiratory distress 0/4623 (0%) 0 4/4617 (0.1%) 4
    Respiratory failure 8/4623 (0.2%) 8 10/4617 (0.2%) 10
    Tonsillar haemorrhage 1/4623 (0%) 1 0/4617 (0%) 0
    Tracheomalacia 1/4623 (0%) 1 0/4617 (0%) 0
    Skin and subcutaneous tissue disorders
    Angioedema 0/4623 (0%) 0 2/4617 (0%) 2
    Dermatitis allergic 1/4623 (0%) 1 0/4617 (0%) 0
    Diabetic ulcer 1/4623 (0%) 1 0/4617 (0%) 0
    Dry gangrene 1/4623 (0%) 1 0/4617 (0%) 0
    Ecchymosis 2/4623 (0%) 2 0/4617 (0%) 0
    Skin ulcer 0/4623 (0%) 0 2/4617 (0%) 2
    Stasis dermatitis 0/4623 (0%) 0 1/4617 (0%) 1
    Social circumstances
    Activities of daily living impaired 1/4623 (0%) 1 0/4617 (0%) 0
    Elderly 0/4623 (0%) 0 1/4617 (0%) 1
    Surgical and medical procedures
    Angioplasty 0/4623 (0%) 0 1/4617 (0%) 1
    Arterial repair 1/4623 (0%) 1 0/4617 (0%) 0
    Cardiac pacemaker battery replacement 0/4623 (0%) 0 1/4617 (0%) 1
    Cardiac pacemaker insertion 1/4623 (0%) 1 0/4617 (0%) 0
    Cataract operation 1/4623 (0%) 1 0/4617 (0%) 0
    Coronary arterial stent insertion 1/4623 (0%) 1 0/4617 (0%) 0
    Coronary artery bypass 7/4623 (0.2%) 7 1/4617 (0%) 1
    Coronary revascularisation 1/4623 (0%) 1 0/4617 (0%) 0
    Hernia repair 1/4623 (0%) 1 0/4617 (0%) 0
    Hospitalisation 0/4623 (0%) 0 1/4617 (0%) 1
    Implantable defibrillator insertion 1/4623 (0%) 1 1/4617 (0%) 1
    Implantable defibrillator replacement 0/4623 (0%) 0 2/4617 (0%) 2
    Knee operation 1/4623 (0%) 1 0/4617 (0%) 0
    Medical device implantation 0/4623 (0%) 0 1/4617 (0%) 1
    Percutaneous coronary intervention 0/4623 (0%) 0 2/4617 (0%) 2
    Rehabilitation therapy 0/4623 (0%) 0 1/4617 (0%) 1
    Umbilical hernia repair 1/4623 (0%) 1 0/4617 (0%) 0
    Vascular disorders
    Accelerated hypertension 0/4623 (0%) 0 1/4617 (0%) 1
    Aortic aneurysm 4/4623 (0.1%) 4 3/4617 (0.1%) 3
    Aortic aneurysm rupture 0/4623 (0%) 0 1/4617 (0%) 1
    Aortic stenosis 3/4623 (0.1%) 3 3/4617 (0.1%) 3
    Arterial disorder 0/4623 (0%) 0 2/4617 (0%) 2
    Arterial insufficiency 1/4623 (0%) 1 0/4617 (0%) 0
    Arterial thrombosis limb 1/4623 (0%) 2 3/4617 (0.1%) 3
    Arteriosclerosis 1/4623 (0%) 1 0/4617 (0%) 0
    Bleeding varicose vein 1/4623 (0%) 1 0/4617 (0%) 0
    Deep vein thrombosis 3/4623 (0.1%) 3 8/4617 (0.2%) 8
    Diabetic vascular disorder 0/4623 (0%) 0 2/4617 (0%) 2
    Distributive shock 1/4623 (0%) 1 0/4617 (0%) 0
    Essential hypertension 1/4623 (0%) 1 0/4617 (0%) 0
    Femoral arterial stenosis 2/4623 (0%) 2 0/4617 (0%) 0
    Haematoma 5/4623 (0.1%) 5 4/4617 (0.1%) 4
    Haemorrhage 2/4623 (0%) 2 1/4617 (0%) 1
    Hypertension 29/4623 (0.6%) 29 24/4617 (0.5%) 24
    Hypertensive crisis 13/4623 (0.3%) 14 11/4617 (0.2%) 12
    Hypotension 8/4623 (0.2%) 8 9/4617 (0.2%) 10
    Hypovolaemic shock 1/4623 (0%) 1 1/4617 (0%) 1
    Iliac artery occlusion 0/4623 (0%) 0 1/4617 (0%) 1
    Iliac artery thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Intermittent claudication 0/4623 (0%) 0 1/4617 (0%) 1
    Lymphoedema 1/4623 (0%) 1 0/4617 (0%) 0
    Orthostatic hypotension 3/4623 (0.1%) 3 3/4617 (0.1%) 4
    Peripheral arterial occlusive disease 13/4623 (0.3%) 13 15/4617 (0.3%) 15
    Peripheral artery aneurysm 1/4623 (0%) 4 0/4617 (0%) 0
    Peripheral embolism 1/4623 (0%) 1 1/4617 (0%) 1
    Peripheral ischaemia 1/4623 (0%) 1 2/4617 (0%) 3
    Peripheral vascular disorder 4/4623 (0.1%) 4 6/4617 (0.1%) 6
    Phlebitis 0/4623 (0%) 0 1/4617 (0%) 1
    Shock 0/4623 (0%) 0 2/4617 (0%) 2
    Subclavian vein thrombosis 0/4623 (0%) 0 1/4617 (0%) 1
    Temporal arteritis 0/4623 (0%) 0 1/4617 (0%) 1
    Thrombophlebitis 1/4623 (0%) 1 1/4617 (0%) 1
    Thrombophlebitis superficial 1/4623 (0%) 1 3/4617 (0.1%) 3
    Varicophlebitis 0/4623 (0%) 0 1/4617 (0%) 1
    Varicose ulceration 0/4623 (0%) 0 1/4617 (0%) 1
    Varicose vein 0/4623 (0%) 0 1/4617 (0%) 1
    Venous insufficiency 0/4623 (0%) 0 1/4617 (0%) 1
    Other (Not Including Serious) Adverse Events
    Prasugrel Clopidogrel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2581/4623 (55.8%) 2494/4617 (54%)
    Blood and lymphatic system disorders
    Anaemia 103/4623 (2.2%) 106 75/4617 (1.6%) 76
    Cardiac disorders
    Angina pectoris 213/4623 (4.6%) 267 250/4617 (5.4%) 320
    Atrial fibrillation 93/4623 (2%) 102 110/4617 (2.4%) 116
    Gastrointestinal disorders
    Abdominal pain upper 41/4623 (0.9%) 44 49/4617 (1.1%) 51
    Constipation 71/4623 (1.5%) 76 81/4617 (1.8%) 83
    Diarrhoea 94/4623 (2%) 99 87/4617 (1.9%) 92
    Dyspepsia 51/4623 (1.1%) 51 51/4617 (1.1%) 52
    Gastritis 50/4623 (1.1%) 52 60/4617 (1.3%) 60
    Gastrooesophageal reflux disease 46/4623 (1%) 47 48/4617 (1%) 49
    Nausea 74/4623 (1.6%) 78 80/4617 (1.7%) 83
    General disorders
    Asthenia 57/4623 (1.2%) 59 45/4617 (1%) 47
    Chest pain 37/4623 (0.8%) 45 48/4617 (1%) 68
    Fatigue 82/4623 (1.8%) 84 70/4617 (1.5%) 75
    Non-cardiac chest pain 108/4623 (2.3%) 125 120/4617 (2.6%) 149
    Oedema peripheral 90/4623 (1.9%) 94 123/4617 (2.7%) 132
    Infections and infestations
    Bronchitis 87/4623 (1.9%) 94 84/4617 (1.8%) 90
    Nasopharyngitis 68/4623 (1.5%) 74 74/4617 (1.6%) 91
    Pneumonia 39/4623 (0.8%) 42 49/4617 (1.1%) 51
    Upper respiratory tract infection 57/4623 (1.2%) 63 75/4617 (1.6%) 82
    Urinary tract infection 101/4623 (2.2%) 116 101/4617 (2.2%) 112
    Injury, poisoning and procedural complications
    Contusion 175/4623 (3.8%) 229 107/4617 (2.3%) 165
    Metabolism and nutrition disorders
    Diabetes mellitus 64/4623 (1.4%) 65 79/4617 (1.7%) 79
    Musculoskeletal and connective tissue disorders
    Arthralgia 64/4623 (1.4%) 71 63/4617 (1.4%) 68
    Back pain 85/4623 (1.8%) 85 90/4617 (1.9%) 96
    Pain in extremity 72/4623 (1.6%) 76 69/4617 (1.5%) 70
    Nervous system disorders
    Dizziness 121/4623 (2.6%) 131 142/4617 (3.1%) 158
    Headache 109/4623 (2.4%) 115 116/4617 (2.5%) 127
    Psychiatric disorders
    Anxiety 63/4623 (1.4%) 63 61/4617 (1.3%) 63
    Depression 60/4623 (1.3%) 61 66/4617 (1.4%) 67
    Insomnia 53/4623 (1.1%) 53 67/4617 (1.5%) 67
    Respiratory, thoracic and mediastinal disorders
    Cough 140/4623 (3%) 142 134/4617 (2.9%) 146
    Dyspnoea 98/4623 (2.1%) 110 116/4617 (2.5%) 120
    Dyspnoea exertional 34/4623 (0.7%) 35 49/4617 (1.1%) 50
    Epistaxis 184/4623 (4%) 265 112/4617 (2.4%) 149
    Skin and subcutaneous tissue disorders
    Ecchymosis 123/4623 (2.7%) 166 65/4617 (1.4%) 78
    Vascular disorders
    Haematoma 116/4623 (2.5%) 141 63/4617 (1.4%) 78
    Hypertension 161/4623 (3.5%) 162 153/4617 (3.3%) 156
    Hypotension 48/4623 (1%) 50 54/4617 (1.2%) 55

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00699998
    Other Study ID Numbers:
    • 11058
    • H7T-MC-TABY(b)
    First Posted:
    Jun 18, 2008
    Last Update Posted:
    May 7, 2013
    Last Verified:
    Mar 1, 2013