Supplemental Appendix

Table of Contents

AngelMed Guardian Product Specifications.......................................................................2Detailed Description of the Confirmation of Thrombotic Coronary Occlusion..................3Figure S1 Expanded Analyses Group Membership.............................................................4Description of Expanded Analyses Development and FDA Submission ...........................5Table S1a Q-Wave Patterns that Qualified as a “New Q-Wave” Based upon a Single Baseline ECG.....................................................................................................7 Table S1b Q-Wave Patterns that Qualified as a “New Q Wave” Based upon Assessment of Two Baseline ECGs.......................................................................................7 Figure S2 Arrival delays from Guardian detection for all confirmed thrombotic events during the 0 to 6 month randomized period.........................................................8Table S2 Number of Events in each Component of the Primary Efficacy Endpoint..........9Table S3 Positive Tests Confirming Occlusive Events by Group during the Randomized Period............................................................................................10 Table S4 Incidence of New Q-Wave MI at 6 Months Follow-Up ECG............................11Table S5 Outcomes in Silent MI Risk Subgroup...............................................................12Table S6 Death through 6 months.....................................................................................13Table S7 Co-Primary Endpoint of Expanded Analysis: PPV and FPR.............................14Table S8 Positive Predictive Value during the 6 Month Randomized Period and the Crossover Period...........................................................................................15Table S9 Other Medical Conditions Detected...................................................................16Appendix A – Enrolling Sites............................................................................................17

1

AngelMed Guardian Implantable Medical Device (IMD) Product Specifications

Item Specification

Dimensions Height (Vertical) Width (Horizontal) Depth

2.10 in (53 mm)2.13 in (54 mm)0.40 in (10 mm)

Weight 1.1 oz (32 grams)Volume 23.4 cm3

2

Confirmation of a Thrombotic Coronary Occlusion Event

For patients with a symptom- to-door time > 2 hours, if no new Q-wave is present, a thrombotic

coronary event was confirmed by the presence of any of the following:

1. ST elevation via 12 lead ECG as determined by blinded, independent Core Lab Review (Duke

Clinical Research Institute ECG Core Lab)

2. If the Guardian System detects a rapidly progressive ST shift event and a thrombotic coronary

occlusion event is not confirmed via a 12 Lead ECG, then a thrombotic coronary occlusion event

may be confirmed via any of the following:

a) Elevated enzymes/biomarkers (CK, CK-MB, or Troponin) per the standard of care at

treating hospital, e.g., above the upper limit of normal and considered within the “necrosis

range” within 24 hours of the onset of ischemic discomfort.

b) A positive stress test

c) Angiography via the presence of any of the following findings: TIMI flow grade < 3, a

corrected TIMI frame count > 40, a TIMI myocardial perfusion grade of 0 or 1, a new

thrombus, a new ulcer, a new distal embolus with an abrupt cutoff, a new dissection or a new

wall motion abnormality as assessed by an independent angiographic core Lab (PERFUSE

Core Lab, Beth Israel Deaconess Medical Center, Harvard Medical School).

3

Figure S1

Expanded Analyses Group Membership

4

Description of Expanded Analyses Development and FDA Submission

Enrollment of the first ALERTS trial subject occurred on December 12, 2008. Enrollment

was capped at 1020 subjects and the final subject completed the 6-month randomization period

on December 19, 2013. Following trial completion a modular premarket approval (PMA) was

submitted to the Food and Drug Administration (FDA):

Module 1 (Pre-Clinical Testing) – March 27, 2014

Module 2 (Quality Manufacturing) – May 16, 2014

Module 3 (ALERTS Trial Clinical Results) – March 16, 2015

An FDA Advisory Panel was convened on March 16, 2016 and recommended against approval

of the device at the conclusion of the meeting. The sponsor received a letter from the FDA on

May 11, 2016 indicating that the sponsor needed to address issues raised at the Advisory Panel to

obtain PMA approval.

The sponsor and FDA met in June of 2016 to review a proposal for a new statistical

analysis plan using post-randomization clinical data previously collected in accordance with the

ALERTS protocol, but not yet adjudicated or analyzed. This post-randomization data became the

basis for the expanded analyses which compared control subjects with alerting turned off

(ALARMS OFF) to ALARMS ON subjects, which included both treatment and control subjects

with alerting turned on. Further, the FDA proposed pre-specification of new clinical endpoints, a

new clinical adjudication process, a new adjudication committee, and a new statistical analysis

prior to any data review to ensure that results met the appropriate level of scientific rigor.

The following steps were performed:

1. A new clinical events committee (CEC) composed of four independent practicing

cardiologists with no previous exposure to the ALERTS trial was assembled. A new

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clinical event adjudication charter was utilized which pre-specified universal definitions

approved by the FDA for myocardial infarction (MI), unstable angina (UA), and

included two new MI definitions that reflected the novel nature of ACS detection

(Aborted MI and Silent MI). At least 3 cardiologists independently adjudicated each

event and a pre-specified tie breaking procedure was implemented.

2. A new set of pre-specified clinical efficacy endpoints were defined and associated

statistical hypotheses were developed. The FDA recommended the primary endpoints

should focus on the accuracy of device detections including positive predictive value and

false positive rate. Secondary endpoints for asymptomatic device detections and an

overall profile of symptom and alarm to door times were also agreed upon.

3. A new process for managing interpretation of false negative data was defined.

Submission of long term safety data (including explant related adverse events) and patient

alarm compliance data was agreed upon. The protocol and detailed statistical analysis plan was

jointly approved by the sponsor and FDA prior to CEC adjudication and analyses. The results

were used to develop an amendment to the PMA submission which was submitted on May 5,

2017 and the PMA was approved on April 9, 2018.

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Table 1a

Q-wave patterns that qualified as a “New Q Wave” Based Upon a Single Baseline ECG

Q-Wave Patterns to Qualify for “New Q-Wave MI” with a Single Baseline

Baseline at Randomization 1 Mo. Visit 3 Mo. Visit 6 Mo. Visit

Absent Present Present Present

Absent Absent Present Present

Absent Absent Absent Present

Table 1b

Q-wave patterns that qualified as a “New Q Wave” Based Upon Assessment of Two Baseline

ECGs

Q-Wave Patterns To Qualify for “New Q-Wave MI” with Dual Baselines

Baseline Pre-Implant Baseline at Randomization 1 Mo. Visit 3 Mo. Visit 6 Mo. Visit

Absent Absent Present Present Present

Absent Absent Absent Present Present

Absent Absent Absent Absent Present

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Figure S2

Arrival delays from Guardian for all confirmed thrombotic events during the 0 to 6 months randomized period

Data based on time from ST shift detection to patient arrival with single positive test (enzymes, ECG, stress test, angio, etc.) as adjudicated by an independent events committee

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Table S2

Number of Events in each Component of the Primary Efficacy Endpoint

Control Group(N=456)

Treatment Group(N=451)

Posterior Probability

N n (%) N n (%)Cardiac or Unexplained Death

447 1 (0.2%) 441 3 (0.7%)New Q-wave MI (Dual Baseline)

427 13 (3.0%) 420 7 (1.7%)Time-to-Door >2 Hours

Look-back Window

7-Day 446 8 (1.8%) 439 4 (0.9%)90-Day 446 17 (3.8%) 439 4 (0.9%)

Composite Primary Endpoint (Dual Baseline)Look-back Window

7-Day 428 20 (4.7%) 423 13 (3.1%) 0.883390-Day 428 28 (6.5%) 423 13 (3.1%) 0.9908

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Table S3

Positive Tests Confirming Occlusive Events by Group during the Randomized Period

Number of Tests

Tests Confirming Event Control Group (N=18)

Treatment Group(N=34)

Cardiac Enzymes ECG Angiograph

yStress Test

4 X X X X 0 1 (2.9%)

3 X X X 2 (11.1%) 1 (2.9%)X X X 1 (5.6%) 3 (8.8%)

2

X X 0 6 (17.6%)X X 2 (11.1%) 4 (11.8%)

X X 1 (5.6%) 5 (14.7%)X X 1 (5.6%) 1 (2.9%)

X X 0 3 (8.8%)

1

X 4 (22.2%) 3 (8.8%)X 5 (27.8%)* 3 (8.8%)

X 1 (5.6%) 2 (5.9%)X 1 (5.6%) 2 (5.9%)

This table includes all confirmed occlusive events that occurred during the randomized period used to calculates time-to-door and late arrival. This table includes events with detection-to-door time <2 hours.*Includes 4 events with ST depression or morphological T wave changes, which were not included in the protocol.

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Table S4

Incidence of New Q-wave MI on 6 Month Follow-up ECG

Baseline ECG Control Group(N=427)

Treatment Group

(N=420)

Difference(Treatment -

Control)95% BCI

Posterior Prob Pr(RT < RC |

data)

Single Baseline 14 (3.3%) 10 (2.4%) (-3.24%, 1.42%) 0.7783Dual Baseline 13 (3.0%) 7 (1.7%) (-3.57%, 0.72%) 0.9015

11

Table S5

Outcomes Among Silent MI Risk Subgroup

Control Group

(N=243)

Treatment Group

(N=222)

Posterior Prob Pr(RT < RC |

data)Single Baseline ECG

New Q-wave 12 (4.9%) 6 (2.7%) 0.8867New Q-wave or Late Arrival (7-day) 14 (5.8%) 8 (3.6%) 0.8542New Q-wave or Late Arrival (90-day) 17 (7.0%) 8 (3.6%) 0.9446

Dual Baseline ECGNew Q-wave 11 (4.5%) 4 (1.8%) 0.9470New Q-wave or Late Arrival (90-day) 16 (6.6%) 6 (2.7%) 0.9471

The silent MI risk subgroup was composed of subjects who met at least one of the following criteria: diabetic, women over the age of 65, history of prior silent ischemia.Posterior probability threshold was not met for any endpoint

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Table S6

Death Through 6 Months

Control Group(N=451)

Treatment Group(N=456)

Cardiovascular 1 3Non-cardiovascular 2 0Total 3 (0.67%) 3 (0.66%)

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Table S7

Co-Primary Endpoint of Expanded Analysis: Positive Predictive Value and False Positive Rate

ALARMS OFFSymptoms Only

ALARMS ONWith or Without Symptoms p-value

Emergency Visits 181 345True Positive 33 89False Positive 148 256PPV 18.2% 25.8% 0.031*FPR (FP/patient year) 0.678 0.164 <0.001**

*One-sided Fisher’s exact test for superiority (significance level = 0.025)**Generalized linear model based on a Poisson distribution and the canonical log link functionPPV = positive predictive value, FPR = false positive rate

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Table S8

Positive Predictive Value during the 6 Month Randomized and the Crossover Period

6 Month Randomization Period Crossover PeriodTreatment Group (ALARMS ON)with or without

symptoms

Control Group (ALARMS OFF)

Control Group (ALARMS ON) with or without

symptomsEmergency Visits 102 181 125True Positives 28 33 34False Positives 74 148 91PPV 27.5% 18.2% 27.2%

During the 6 month randomized period the treatment group had alarms turned on and the control group had alarms turned off. Data on the control group after the alarms were turned after the completion of the randomized period (crossover period) are also presented.PPV = Positive Predictive Value

15

Table S9

Other Medical Conditions Detected by Guardian Alerts

Medical Condition Detected Number of Events Number of Subjects(N = 910)

Anemia 12 11 (1.2%)Atrial Fibrillation 33 26 (2.9%)Bradycardia 18 17 (1.9%)New Onset Bundle Branch Block 9 8 (0.9%)Hypokalemia 9 8 (0.9%)Tachycardia 25 19 (2.1%)Transient Heart Block 2 2 (0.2%)Total 108 79 (8.7%)

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Appendix A - Enrolling Sites

Germany

Albert Ludwig University of FreiburgPrincipal Investigator: Manfred Zehender, Prof. Dr.Research Coordinator: Gudrun Heinrichs

The United States

Alabama

Huntsville Hospital / Heart Center ResearchPrincipal Investigator: Jay Dinerman, MDResearch Coordinator: Lisa Eskridge

Arizona

Banner Good Samaritan HospitalPrincipal Investigator: Asish Pershad, MDResearch Coordinator: Elizabeth Russo, RN

Banner Heart HospitalPrincipal Investigator: Andrew Kaplan, MDResearch Coordinator: Heidi Terry, MN, RN, CCRC

Southwest Heart GroupPrincipal Investigator: Brenda C. Peart, MDResearch Coordinator: Ken Peart, CCRC

California

California Clinical Research FoundationPrincipal Investigator: Joseph Ghazal, MDResearch Coordinator: Murali Gali, MD

Huntington Memorial HospitalPrincipal Investigator: Mayer Rashtian, MDResearch Coordinator: Samia Solh, RN

John Muir Clinical Research CenterPrincipal Investigator: Ayman Hosny, MDResearch Coordinator: Suzanne Clements, RN, BSN, CCRC

17

Long Beach Memorial Medical CenterPrincipal Investigator: John Messenger, MD Serge Tobias, MDResearch Coordinator: Kim West, ACNPC

Orange County Heart Institute and Research CenterPrincipal Investigator: Kelly Tucker, MDResearch Coordinator: Karena D La Mora, CRC

Radiant ResearchPrincipal Investigator: Sanjay Dhar, MDResearch Coordinator: Sabine Ucik, CCRC

Salinas Valley Memorial HospitalPrincipal Investigator: Robert Wlodarczyk, DOResearch Coordinator: Terri Nielsen RN, BSN, CCRC

Sutter Memorial HospitalPrincipal Investigator: David Roberts, MDResearch Coordinator: Deborah Holmes-Rees, RN

University of California – Davis Medical CenterPrincipal Investigator: Reginald Low, MDResearch Coordinator: Lisa Ayer-Rand RN, BSN, CCRP

Florida

Bay Pines VA Healthcare SystemPrincipal Investigator: Philip Stromquist, MDResearch Coordinator: Hafida Nekach, MD, CCRC

Daytona Heart GroupPrincipal Investigator: Glenn Rayos, MDResearch Coordinator: Terry Purcell

East Coast Institute for Research – Flagler HospitalPrincipal Investigator: Ferris George, MDResearch Coordinator: Rebecca Rossenwasser, PharmD, CCRP

Edgewater Medical Research, Inc.Principal Investigator: Eric Lo, MDResearch Coordinator: Tina Blount, CRC

Florida Hospital-Pepin Heart InstitutePrincipal Investigator: Charles R. Lambert, MDResearch Coordinator: Elizabeth Szymanski, RN, MSN

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Holy Cross HospitalPrincipal Investigator: Rishi Anand, MDResearch Coordinator: Cheryl Langer

Mercy Research InstitutePrincipal Investigator: Manual Mayor, MDResearch Coordinator: Jose Quesada

New Phase Clinical TrialsPrincipal Investigator: Juan Carlos Londono, MDResearch Coordinator: Lourdes Gonzalez

North FL / South GA VA Health SystemPrincipal Investigator: Mark Panna, MDResearch Coordinator: Susan Stinson

University of Miami Health SystemsPrincipal Investigator: Claudia A. Martinez, MDResearch Coordinator: Bonni Lang, RN

University of South FloridaPrincipal Investigator: Philip Rogal, MDResearch Coordinator: Jessica Walker

Georgia

Medical Center, Navicent Health (formerly Medical Center of Central Georgia)Principal Investigator: Mark Dorogy, MDResearch Coordinator: Carrie Knott, RN, BSN, MPH, CCRC

Piedmont HospitalPrincipal Investigator: Andrew Wickliffe, MDResearch Coordinator: Kristi Picardi

Illinois

Advocate Medical GroupPrincipal Investigator: Barry Laskoe, DOResearch Coordinator: Gabriella Fini

Northwestern Bluhm Cardiovascular Institute Principal Investigator: Dan J. Fintel, MDResearch Coordinator: Elonia Martin, BA

19

Prairie EducationPrincipal Investigator: Ziad Issa, MDResearch Coordinator: Michael Diefenback

Indiana

Heart Center of Lake CountyPrincipal Investigator: Andre K. Artis, MDResearch Coordinator: Kimberly Armstrong, RN BSN, MBA

Medical Consultants, PCPrincipal Investigator: Bruce M. Graham, MDResearch Coordinator: Sherry Adair, RN

Northern Indiana Research AlliancePrincipal Investigator: Sree Karanam, MDResearch Coordinator: Tracy Miller

IU Health Bloomington (formerly Premier Healthcare, LLC)Principal Investigator: John Strobel, MDResearch Coordinator: Amber Brooks-Wolfe, LPN, CCRC

Kentucky

Baptist Health LexingtonPrincipal Investigator: Paula Hollingsworth, MDResearch Coordinator: Julie Ayers, RN, BSN

Louisiana

Heart Clinic of HammondPrincipal Investigator: Ghiath Mikdadi, MDResearch Coordinator: Cheryl Clavier Firmin, AAS, CRC

Innovative Medical ResearchPrincipal Investigator: Dale Presser, MDResearch Coordinator: Candice Crespo

Louisiana Heart CenterPrincipal Investigator: Bruce J. Iteld, MDResearch Coordinator: Brandy Ocman, RN

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Maryland

MedStar Health Research Institute / Good Samaritan HospitalsPrincipal Investigator: Jerald Insel, MDResearch Coordinator: Cynthia Lynn Yashinski, BA, CCRC

Suburban HospitalPrincipal Investigator: Gregory Kumkumian, MDResearch Coordinator: Ann Greenberg, RN

University of Maryland Medical CenterPrincipal Investigator: Peter Reyes, MDResearch Coordinator: Lori Black

Washington Adventist HospitalPrincipal Investigator: Sean Beinart, MDResearch Coordinator: Melissa Ramey

Michigan

Borgess Heart InstitutePrincipal Investigator: Vishal Gupta, MD; Glenn Kabell MDResearch Coordinator: Sandy Wilson

Cardiac & Vascular Research Center of Northern MichiganPrincipal Investigator: Harry T. Colfer, MDResearch Coordinator: Jennifer LaLonde, RN, BSN, CCRC

Cardiology Consultants of East MichiganPrincipal Investigator: Abdul Alawwa, MDResearch Coordinator: Tina Marie Conyer

Detroit Clinical Research Center – GrodmanPrincipal Investigator: Robert Grodman, DOResearch Coordinator: Candice Shallal, BS

DMC Cardiovascular Institute at Harper-Hutzel HospitalPrincipal Investigator: Theodore Schreiber, MDResearch Coordinator: Marybeth McCarthy

Genesys Regional Medical CenterPrincipal Investigator: Marc Silver, MDResearch Coordinator: Sandy Watt, RN

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McLaren Bay RegionPrincipal Investigator: Daniel Taehee Lee, MDResearch Coordinator: Colette Quart, RN, BSN, CCRC

Sparrow Clinical Research InstitutePrincipal Investigator: Guarav Dhar, MDResearch Coordinator: Heidi Taylor, RN, BSN

Spectrum HealthPrincipal Investigator: David Wohns, MDResearch Coordinator: Karen Postema

Minnesota

Mayo ClinicPrincipal Investigator: Yong-Mei Cha, MDResearch Coordinator: Jacqueline Wanek, RN

New Jersey

Jersey Shore University Medical CenterPrincipal Investigator: Charles Koo, MDResearch Coordinator: Anne Marie DeToro, RN, BS, CCRC

Lourdes Cardiology ServicesPrincipal Investigator: Devender Akula, MD; Darius Sholevar, MDResearch Coordinator: Maura Kendall

St. Michaels Medical CenterPrincipal Investigator: Abbas Shehadeh, MDResearch Coordinator: Raymond Monel, MS, RC, C-HIR-Pro

University of Medicine and Dentistry NJPrincipal Investigator: Tudor Vagaonescu, MDResearch Coordinator: Erin Squindo, LPN

New York

Albany Associates in CardiologyPrincipal Investigator: Eric Roccario, MDResearch Coordinator: Peggy Sue Shaummann-Boyle, RN

Buffalo Heart GroupPrincipal Investigator: A.R. Zaki Masud, MD, Research Coordinator: Jodi Skinner, RN, CCRP

22

Cardiology Group of Western New York, P.C.Principal Investigator: Salvatore Calandra, MDResearch Coordinator: Kyle Mann

Columbia University Medical CenterPrincipal Investigator: Tamim Nazif, MDResearch Coordinator: Treena Williams

Mercy Hospital of BuffaloPrincipal Investigator: Irfan Khan, MD; Michael Hong, MDResearch Coordinator: Theresa Giambra, RN, CCRP

Stony Brook University Medical CenterPrincipal Investigator: Eric Rashba, MDResearch Coordinator: Jennifer Intravaia

SUNY Downstate Medical CenterPrincipal Investigator: John Kassotis, MDResearch Coordinator: Ann Harris, NP

North Carolina

REX HealthcarePrincipal Investigator: Sameh K. Mobarek, MDResearch Coordinator: Rebecca Palermo

Ohio

Cardiovascular Research CenterPrincipal Investigator: Ameer Kabour, MDResearch Coordinator: Michelle Hickam, RN

Good Samaritan HospitalPrincipal Investigator: Gary Fishbein, MDResearch Coordinator: Annie Neff, RN, BSN

University of ToledoPrincipal Investigator: Thomas Schwann, MDResearch Coordinator: Terri Kozi

Oklahoma

South Oklahoma Heart Research, LLCPrincipal Investigator: Naeem K. Tahirkheli, MDResearch Coordinator: Adriana Santos, CCRC

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Pennsylvania

Allegheny-Singer Research InstitutePrincipal Investigator: David Lasorda, MDResearch Coordinator: Kenneth Rayl

Donald Guthrie Foundation for Education & ResearchPrincipal Investigator: Govindarajan Venkatesh, MDResearch Coordinator: Donna Tyburczy, RN, BSN, CCRP

Drexel University College of MedicinePrincipal Investigator: John M. Fontaine, MDResearch Coordinator: Shawn Cone

Geisinger Medical CenterPrincipal Investigator: Jess Oren, MDResearch Coordinator: Susan Kilbride

Lancaster General HospitalPrincipal Investigator: Seth J. Worley, MDResearch Coordinator: Kay M. Knepper, RN

Penn State Hershey Medical CenterPrincipal Investigator: Ian Gilchrist, MDResearch Coordinator: Kevin Gardner

St. Mary Medical Center Research InstitutePrincipal Investigator: Rakesh Shah, MDResearch Coordinator: Marci Petrino, BSN, CCRP

Cardiac Diagnostic Associates/York HospitalPrincipal Investigator: Brian Schuler, MDResearch Coordinator: Barb Delio-Cox

South Carolina

AnMed HealthPrincipal Investigator: Satish Surabhi, MDResearch Coordinator: Charles A Davis, RN, BSN

Greenville Hospital SystemPrincipal Investigator: Arthur Eberly III, MDResearch Coordinator: Donita O’Hearn, RN, BSN, CCRP

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Tennessee

St. Thomas Research InstitutePrincipal Investigator: George H. Crossley III, MDResearch Coordinator: Danielle Buchanan, RN

The Stern Cardiovascular CenterPrincipal Investigator: Frank McGrew, MDResearch Coordinator: Brian Dragutsky

Turkey Creek Medical CenterPrincipal Investigator: Malcolm Foster, MDResearch Coordinator: Beth Polk, RN, CCRC

Texas

Cardiology Center of Amarillo (Clinical Tex Research, LLC)Principal Investigator: Sammy Lane Cox, MDResearch Coordinator: Amy Tucker, CRC

Scott and White Memorial HospitalPrincipal Investigator: Peter Cheung, MDResearch Coordinator: Wanda Fikes, RN

Tyler Cardiovascular Consultants, PAPrincipal Investigator: Robert Carney, MDResearch Coordinator: Greg Murphy

West Houston Area Clinical Trial Consultants – HaasPrincipal Investigator: Philip Clay Haas, DOResearch Coordinator: Jawad Ashour

West Houston Area Clinical Trial Consultants, LLCPrincipal Investigator: Amir Kashani, MDResearch Coordinator: Neil Schmitz

Virginia

Bayview Physician Services (formerly Cardiovascular Associates, LTD)Principal Investigator: John Griffin, MDResearch Coordinator: DeAnne Grove, BSN, RN, CRC

Cardiology Associates of FredericksburgPrincipal Investigator: Ashok Talreja, MDResearch Coordinator: Mary Lou Hollingshead, RN

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Inova Cardiology Ambulatory Research (formerly Cardiovascular Associates of Virginia)Principal Investigator: Shahram Yazdani, MDResearch Coordinator: Kathleen Morgan

Riverside Regional Medical CenterPrincipal Investigator: Allan Murphy, MBBSResearch Coordinator: Virginia Oehmann

Sentara Cardiovascular Research Institute Principal Investigator: Allen Ciuffo, MDResearch Coordinator: Tina Calayo

Washington

Swedish Medical Center / Cardiovascular ResearchPrincipal Investigator: John Peterson II, MDResearch Coordinator: Inger Rasmussen, BA, CCRC

Washington DC

Washington Hospital CenterPrincipal Investigator: Ron Waksman, MDResearch Coordinator: Michelle Deville

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