Document text
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16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND SUBJECTS BY THE COUNTRY
Total Number of Sites (Per Study ):153
Total Number of Subjects Screened (Per Study ): 48092
Total Number of Subjects Randomized/Entered (Per Study ):45121
ARGENTINA
Number of Sites (Per Country ): 1
Number of Subjects Screened (Per Country ): 5896
Number of Subjects Randomized/Entered (Per Country ): 5615
Coordinating Investigator:
<None Entered>
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1231 Fernando
PolackDiego Tourn
Virginia Trias Uriarte
Anabel Vaca Lizzi
Rita Valdez
Antonela Valente
Emmanuel Valls
Mercedes Vazquez
Elizabeth Ventrice
Maria Vera
Morandini
Ana Liss Vergez
Alejandra de Lourdes
Vigliano
Vanina Vilaseca
Florencia Virili
Juan VoievdcaHospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Luis María Campos 726 Piso 8
CABA, 1426
ARGENTINA5896 5615
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Marino Volpe
Santiago Vommaro
Diego Wappner
Maria Werbach
Cristian Wood
Rom ina Zadoff
Agustina Zavaleta
Marisa Zocca
Nicolas de Pro
Solange Acosta
Altabe(Previous
SubI)
Paula
Agosti(Previous
SubI)
Omar
Aguayo(Previous
SubI)
Gaston Agudo
Franco(Previous
SubI)
Caterina Lisette
Aguilar
Rom an(Previous
SubI)
Antonio
Aguilera(Previous
SubI)
Maria Florencia
Aiccardi(Previous
SubI)
Maria
Airoldi(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Mariana
Albarracin(Previous
SubI)
Maria
Allende(Previous
SubI)
Isabel Alvarez
Burgos(Previous
SubI)
Federico Alvarez
Loray(Previous SubI)
Anabella Alvarez
Mandias(Previous
SubI)
Maria
Anoni(Previous SubI)
Daniel Aput(Previous
SubI)
Guillermo
Aquino(Previous
SubI)
Esteban Araujo
Ramos(Previous
SubI)
Paula
Asanovic(Previous
SubI)
Maria
Ascarate(Previous
SubI)
Victoria
Auzmendi(Previous
SubI)
Cristian
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Avellino(Previous
SubI)
Maria
Avena(Previous SubI)
Maria
Baccini(Previous
SubI)
Maria
Bachella(Previous
SubI)
Laura Baffa(Previous
SubI)
Lorena
Bajinay(Previous
SubI)
Magdalena
Bajo(Previous SubI)
Sebastian
Batagelj(Previous
SubI)
Néstor Bautista
Herrera(Previous
SubI)
Gabriela
Belachur(Previous
SubI)
Federico
Bianco(Previous
SubI)
Juan
Bidegain(Previous
SubI)
Jessica
Bilstein(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Ricardo
Blanco(Previous
SubI)
Maria Borio(Previous
SubI)
Maria Cecilia
Bourgeois(Previous
SubI)
Benjamin
Buteler(Previous
SubI)
Guillermo
Calderon(Previous
SubI)
Belen
Camardelli(Previous
SubI)
Maria
Camean(Previous
SubI)
Alejandro
Capdevilla(Previous
SubI)
Maria Carballo
Lencina(Previous
SubI)
Federico
Cardozo(Previous
SubI)
Hugo
Carranza(Previous
SubI)
Gustavo
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Casado(Previous
SubI)
Andrea
Castelo(Previous
SubI)
Cyntia
Castro(Previous SubI)
Fabian Castro
Barros(Previous
SubI)
Francisco Castro
Montiel(Previous
SubI)
Viviana Elizabeth
Cavenago(Previous
SubI)
Analía
Christmann(P revious
SubI)
Ivana Cobos(Previous
SubI)
Paola
Codianni(Previous
SubI)
Milena
Corengia(Previous
SubI)
Sofia Costa(Previous
SubI)
Ignacio
Croci(Previous SubI)
Maria
Cuervo(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Valeria
Cugnu(Previous
SubI)
Dolores
Curubeto(Previous
SubI)
Maria D'Angelo
Exeni(Previous SubI)
Rafael
Dalpra(Previous
SubI)
Barbara De
Nardo(Previous SubI)
Dario Del
Percio(Previous SubI)
Micaela
Delgado(Previous
SubI)
Julia Delgado
Riveros(Previous
SubI)
Mariela
Deraiopian(Previous
SubI)
Melisa
Dollanart(Previous
SubI)
Lourdes Dominguez
Figueredo(Previous
SubI)
Belen
Duarte(Previous
SubI)
Mariana
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Dunaiewsky(Previous
SubI)
Andrea del Socorro
Duque
Ramirez(Previous
SubI)
Francisco
Dusio(Previous SubI)
Maria
Etchegaray(Previous
SubI)
Nicolas Falk(Previous
SubI)
Emanuel Fedun
Rodriguez(Previous
SubI)
Martina
Fernandez(Previous
SubI)
Jose Fernandez
Abuye(Previous
SubI)
Isabel Abramovich
Maria Accorinti
Carla Airoldi
Mariano Aizpurua
Graciela Alegre
Julieta Alfonso
Maria Andreau
Julieta Arredondo
Martinez
Maria Azpiroz
Luis Balaguer
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Carola Baldoni
Lucrecia Bandeo
Alan Barrego
Mirta Becerra Pons
Sebastian Belchior
Cynthia Belo
María Bengoa
Maria Beretta
Antonella Berutti
Favio Bigas
Felipe Bilbao
Maria Blanco
Lucia Bonfada
Monserrat Boroni
Barbara Braun
Maria Breppe
Sergio Buscazzo
Jorgelina Candia
Angela Carbajal
Maldonado
Federico Cardahi
Josefina Carrano
Barbara Carrizo
Lorena Casal
Ana M aria Casalins
Analia Castellano
Maria Castillo Areco
Rom ina Castro
Maria Cedron
Solana Ceretti
Marian Chacoff
Yolanda Chanampa
Agustina Chidichimo
Manuel Clavijo
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Juan Cocca Gioco
Florencia Cogo
Orellana
Luciana Compostela
Santiago Corradetti
Sergio Cortez
Gabriel Cracovski
Mariano Crespo
Evangelina Cueto
Jesica Cufre
Maria D`Ascoli Onel
Martin Darraidou
Florencia De Lafore
Valeria De Lassaletta
Jimena Del Rincon
Alejandra Destito
Soljan
Patricia Devesa
Victoria Di Nardo
Lucila Di Nunzio
Alejandro Diaz
Maria Diez
Ana Donnari
Ana Belen Duarte
Sabrina Dulce
Pablo Echeverria
Maria Espinosa
Ignacio Esteban
Sara Esteche Roman
Samanta Estevez
Natali Estrada
Tatiana Estrada
Vanesa Fainboim
Florencia Feldman
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Valentina Fernandez
Alberdi
Paula Fernández
Estrella
Andres Ferreyra
Santiago Foti
Jimena Franco
Paula Franco
Jorge Fuentes
Maria Fulco
Agustina Furnari
Agustin Galarza
Juan Galeano
Carmen Gallastegui
Victoria Garcia
Julieta Gelardi
Eduardo Gimenez
Facundo Gonzalez
Jose Luis Gonzalez
Adolfo Gonzalez
Osorio
Marina Guglielmino
Maria Gutierrez
Meyer
Leandro Heffner
Luciana Hernandez
Maria Herrera Jure
Maria Herrera
Ledesma
Pablo Hurevich
Lucia Fernandez
Abuye(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Nicolas
Ferrari(Previous
SubI)
Juan
Ferraris(Previous
SubI)
Karen de Fatima
Figueroa
Bohorquez(Previous
SubI)
Hernan
Freire(Previous SubI)
Maria Victoria
Eugenia Gaete
Orueta(Previous
SubI)
Mariano
Garabito(Previous
SubI)
Belkys
Garcia(Previous
SubI)
Emiliano Garcia
Coloccini(Previous
SubI)
Natalia Garcia
Escude(Pr evious
SubI)
Tom as Garcia
Solchaga(Previous
SubI)
Ezequiel
Gayer(Previous SubI)
Sergio
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Gelman(Previous
SubI)
Maria
Ghiberti(Previous
SubI)
Maria
Gimenez(Previous
SubI)
Laura
Giovanetti(Previous
SubI)
Virginia
Godoy(Previous
SubI)
Barbara
Gom ez(Previous
SubI)
Adriana Goncalves de
Almeida(Previous
SubI)
Liliana
Gonzalez(Previous
SubI)
Maria
Gonzalez(Previous
SubI)
Ezequiel
Graziano(Previous
SubI)
Julia
Grigioni(Previous
SubI)
Sebastian
Grinstein(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Jhonatan Guerrero
Gallego(Previous
SubI)
Johana Gutierrez
Perez(Previous SubI)
Ruth
Henquin(Previous
SubI)
Luis
Heredia(Previous
SubI)
Milagros
Heredia(Previous
SubI)
Rocío
Heredia(Previous
SubI)
Alejandra
Hintze(Previous
SubI)
Macarena
Ilarregui(Previous
SubI)
Maria
Irigoyen(Previous
SubI)
Hernán
Jamui( Previous SubI)
Ximena
Juarez(Previous SubI)
Veronica Junyent
Berrotaran(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Andres
Kogan(Previous
SubI)
Paola
Koslowski(Previous
SubI)
Jose Labella(Previous
SubI)
Eduardo
Landa(Previous SubI)
Fernando
Landreau(Previous
SubI)
Martina
Leonard(Prev ious
SubI)
Juan Lopez(Previous
SubI)
Juan Lopez(Previous
SubI)
Agustin
Losinno(Previous
SubI)
Juan Martin Lourenco
da Cunha(Previous
SubI)
Federico
Luna(Previous SubI)
Flavia Luna
Matheu(Previous
SubI)
Julieta
Maffia(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Natalia
Mammana(Previous
SubI)
Ana
Mansilla(Previous
SubI)
Natalia Mansilla
Irusta(Previous SubI)
Felix
Marasco(Previous
SubI)
Betiana
Martin(Previous
SubI)
Paola
Martin(Previous
SubI)
Maximiliano
Martinez(Previous
SubI)
Maria
Martino(Previous
SubI)
Ines
Mattausch(Previous
SubI)
Anabella
Mazzeo(Previous
SubI)
Maria Florencia
Mazzeo(Previous
SubI)
Tom as
Meglia(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Luis Eduardo
Molinari(Previous
SubI)
Maria
Molise(Previous
SubI)
Graciela
Montaner(Previous
SubI)
Leandro Montaña
Espindola(Previous
SubI)
Marco Morales
Morales(Previous
SubI)
Samanta
Moroni(Previous
SubI)
Josefina
Mosteirin(Previous
SubI)
Gisela
Muller(Previous
SubI)
Alan Mysler(Previous
SubI)
Rocio
Navarro(Previous
SubI)
Pablo
Naveira(Previous
SubI)
Marco Antonio
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Nogara(Previous
SubI)
Gabriela
Norese(Previous
SubI)
Gabriela
Novoa(Previous
SubI)
Gaston
Ofman(Previous
SubI)
Marco
Ottino(Previous SubI)
Maria
Oyarvide(Previous
SubI)
Salome
Pagni(Previous SubI)
Florencia
Palmieri(Previous
SubI)
Mariana
Palopoli(Previous
SubI)
Mariela
Panichel la(Previous
SubI)
Maria Pattin(Previous
SubI)
Anabella
Pecheny(Previous
SubI)
Constanza
Peire(Previous SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Fernando Peralta
Luna(Previous SubI)
Maria Perez
Latessa(Previous
SubI)
Carlos
Pessolani(Previous
SubI)
Andres
Petrocelli(Previous
SubI)
Diana
Pieniazek(Previous
SubI)
Silvina
Polacov(Previous
SubI)
Felipe
Pomes(Previous
SubI)
Evangelina
Pujadas(Previous
SubI)
Florencia
Quadrana(Previous
SubI)
Valeria Quinteros
Caceres(Previous
SubI)
Manuel
Quiroz(Previous
SubI)
Valeria
Quispe(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Agustin Quiñones
Maffassanti(Previous
SubI)
Alejo Quiñones
Maffassanti(Previous
SubI)
Maria
Rajuan(Previous
SubI)
Noelia Iraizos Zegarra
Nicolas Itcovici
Maria Jelovina
Yadira Jimenez
Garcia
Valeria Kes
Fernando Lanzilotti
Lorena Larroude
Carolina Laurence
Irina Leon Romero
Rom ina Libster
Jimena Lopez Arroyo
Rocio Lopez Castelo
Natalia Lozano
Gabriela Lucero
Clarice Madureira
Cena
Carolina Magadan
Miguel Magallanes
Quijandria
Fernando Magdalena
Ezequiel Maldonado
Maria Malvicino
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Janet del V alle
Manrique Lopez
Valeria Manzanares
Carla Marchionatti
Leticia Marcos
Daniela Marino
Claudia Martinez
Macarena Martinez
Crespo
Ines Martinez Rom ero
Maria Martí
Maria Marugo
Gisela Maspero
Jose Meana Gonzalez
Maria Melito
Soledad Mendoza
Geraldo Meza
Santiago
Cintia Morales
Ileana Moreira
Varanese
Amalia Moschen
Natalia Mozeluk
Dalila Nafeh
Ronquillo
Maria Name
Lucia Narvaez
Luis Neira
Maria Neira
Cinthia Nenninger
Sabrina Nowicky
Juan Nuñez
Natalia Nuñez
Jimena Ochoa
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Sabrina Odriozola
Maria Pia Olivera
Abdala
Emilio Ominetti
Agustina Ordoñez
Melisa Orrego
Lucila Orsomarso
Graciela Ortiz
Eliana Ortiz Tolaba
Maria Paladino
Maria Panighetti
Maria Clara Perez
Rafael Perez Vidal
Maria Pirker Asategui
Maria Pitocco
Sebastian Pogliani
Gonzalo Pér ez Marc
Noelia Quispe
Maria Ramon
Paula Ramos
Micaela Re Furci
Patricia Rearte
Carvalho
Valeria Regairaz
Debora Reichbach
Rom ina Renner
Maria Rey
Yanina Rivera
Ana Riveros
Cecilia Robledo
Paula Robredo
Maria Roque
Silvia Rossi
Maria Ruffa
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Maria Ruiz Cobos
Betiana Sabbattini
Tatiana Sanchez
Quiroga
Francisco Santucho
Saravia
Daniel Sartorelli
Johanna Sas
Judith Scherman
Lionel Schuster
Georgina
Sciancalepore
Virginia Seguel Jabat
Gonzalo Sola
Giuliana Sposito
Diego Staffieri
Lila Sueldo
Valeria Svartman
Mene zes
Daniela Szlaen
Raul Taboada
Florencia Tedeschi
Juan Torres Moirano
Pablo
Ramondelli(Previous
SubI)
Mariel
Rando(Previous SubI)
Cecilia Ray(Previous
SubI)
Luciana
Real(Previous SubI)
Carlos
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Reguera(Previous
SubI)
Maria
Retrivi(Previous
SubI)
Micaela
Rivero(Previous
SubI)
Flor Robalino
Muñiz(Previous SubI)
Sergio
Rodas(Previous SubI)
Lucia
Rodriguez(Previous
SubI)
Rom ina Rodriguez
Coria(Previous SubI)
Cintia
Rom anelli(Previous
SubI)
Rom ina
Rom ero(Previous
SubI)
Guillermina Roveda
Verges(Previou s
SubI)
Florencia
Salani(Previous SubI)
Sofia Salvia(Previous
SubI)
Myriam
Sanchez(Previous
SubI)
Martha Sanchez
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Navarro(Previous
SubI)
Maria
Sandoval(Previous
SubI)
Gaspar
Sanfilippo(Previous
SubI)
Ignacio
Santarelli(Previous
SubI)
Agustina
Santoni(Previous
SubI)
Agustina del Rosario
Sbruzzi(Previous
SubI)
Micaela
Schiavi(Previous
SubI)
Ana
Schindler(Previous
SubI)
Laura
Schiró(Previous SubI)
Violeta
Schneider(Previous
SubI)
Tamara
Schvarstein(Previous
SubI)
Agostina
Sdrigotti(Previo us
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Fernando
Sebastiani(Previous
SubI)
Armando
Segret(Previous SubI)
Franco
Servat(Previous SubI)
Jose Shiraishi
Ferreyra(Previous
SubI)
Lucinardo Soares
Belarmino(Previous
SubI)
Barbara
Soberon(Previous
SubI)
Martin Soria(Previous
SubI)
Eleonora
Sorin(Previous SubI)
Barbara
Sparrow (Previous
SubI)
Patricia
Stach(Previous SubI)
Esteban
Suarez(Previous
SubI)
Analia Suarez
Pulido(Previous SubI)
Martin
Taboada(Previous
SubI)
Natali Tanel(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Maria Tarrazo
Barranco(Previous
SubI)
Luciana
Terracin a(Previous
SubI)
Mariana
Thuns(Previous SubI)
Sebastian
Tisman(Previous
SubI)
Laura Tisser(Previous
SubI)
Elda Tralice(Previous
SubI)
Ignacio
Uriarte(Previous
SubI)
Nancy
Urquiza(Previous
SubI)
Paula Valdez
Tappata(Previous
SubI)
Leandro Vallejos
Insegna(P revious
SubI)
Federico
Vecchietti(Previous
SubI)
Gabriela
Vecchio(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Juan Jose
Vega(Previous SubI)
Victoria
Verga(Previous SubI)
Javier
Veron(Previous SubI)
Sebastian
Vidaurreta(Previous
SubI)
Patricia Vides De la
Hoz(Previous SubI)
Florencia Villegas
Herbas(Previous
SubI)
Dayler Virgo
Zambrana(Previous
SubI)
Virginia
Visco(Previous SubI)
Veronica
Wahren(Previous
SubI)
Diego
Waserman(Previous
SubI)
Giselle
Wehit(Previous SubI)
Anastasiya
Yashnyk(Previous
SubI)
Joaquin
Zunzuneguy(Previous
SubI)
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BRAZIL
Number of Sites (Per Country ): 2
Number of Subjects Screened (Per Country ): 2927
Number of Subjects Randomized/Entered (Per Country ): 2880
Coordinating Investigator:
<None Entered>
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1226 Cristiano
ZerbiniBreno Balabem Alves
Marta Bastos
Fernando Brunori
Sonia Debbio
Emerson Gimenez
Mariana Gioielli
Waisberg
Raissa Gomes da
Silva
Andrea Lomonte
Flora Marcolino
Marcio Neis
Maria Nunes
Valéria Silveira TellesCEPIC -Centro Paulista de Investigacao Clinica e Servicos Medicos
Ltda (Casa Branca)
Rua Moreira e Costa, 342 -Ipiranga
Sao Paulo/SP, 04266 -010
BRAZIL1360 1336
1241 Edson Moreira Lais Almeida Silva
Carolina Barbosa
Gracimara De Jesus
Santos
Rafaela Machado
Leal Borges
Marcus Paulo Pagani
Passos
Beatriz Pereira dos Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
Avenida Dendezeiros do Bonfim, N° 161
Salvador, BAHIA CEP: 40415 -006
BRAZIL1567 1544
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Santos
Yuri Boa Sorte de
Oliveira
Dom inique da Silva
João Soares
Costa(Previous SubI)
Rafael Solla
Galvão(Previous
SubI)
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CONFIDENTIAL 19-Mar-2021 16:13:09 GMT
GERMANY
Number of Sites (Per Country ): 6
Number of Subjects Screened (Per Country ): 514
Number of Subjects Randomized/Entered (Per Country ): 492
Coordinating Investigator:
<None Entered>
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subje cts
Screened
per SiteSubjects
Randomized/
Entered per Site
1185 Mary lyn Addo Kirsten Eberhardt
Tamara Nordmann
Michael Ramharter
Stefan Schmiedel
Parichehr ShamsriziUniversitätsklinikum Hamburg -Eppendorf
Bernhard Nocht Centre for Clinical Trials - Bernhard -Nocht -Institut für
Tropenmedizin
Bernhard -Nocht -Str. 74
Ham burg, 20359
GERMANY67 63
1194 Andreas Eich Marc Kornmann
Stefanie
Franke(Previous
SubI)IKF Pneumologie GmbH & Co KG
Institut fü r klinische Forschung
Schaumainkai 101 -103
Frankfurt am Main, 60596
GERMANY106 102
1195 Axel Schaefer Mazin Sanuri Medizentrum Essen Borbeck
Huelsmannstrasse 6
Essen, 45355
GERMANY158 156
1197 Matthias
LuttermannTorsten Drescher
Lars PohlmeierStudienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher
Melcherstaette 7
Stuhr, 28816
GERMANY100 100
1202 Armin Schultz Friedeborg Seitz CRS Clinical Research Services Mannheim GmbH 13 12
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subje cts
Screened
per SiteSubjects
Randomized/
Entered per Site
Marina Streckebein Grenadierstr. 1
Mannheim, 68167
GERMANY
1203 Sybille
BaumannMatthias Berse
Manuela Casjens
Luca Eibach
Jonas Eppel
Julian Hugo
Wilhelm
Koch -Sembdner
Alexander
Niewiadomski
Mares -Elaine
StremplerCRS Clinical Research Services Berlin GmbH
Sellerstr. 31
Berlin, 13353
GERMANY70 59
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SOUTH AFRICA
Number of Sites (Per Country ): 4
Number of Subjects Screened (Per Country ): 842
Number of Subjects Randomized/Entered (Per Country ): 788
Coordinating Investigator:
<None Entered>
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1229 Essack Mitha Salim Ahmed
Ilunga Kapanga
Naom ie Kapanga
Fatima Sirkhotte
Nokuthula
Khumalo(Previous
SubI)Newtown Clinical Research Centre
104 Jeppe Street, New town, Suite 3, Newgate Centre
Johannesburg, GAUTENG 2113
SOUTH AFRICA217 206
1230 Leon Fouche Michiel Buys
Muhammed Fulat
Danellus Van der
Watt
Pieter -Louis
Vollgraaff
Thinti
Moreroa(Previous
SubI)Limpopo Clinical Research Initiative
Tamboti Medical Centre
11 Van der Bijl Street
Thabazimbi, LIMPOPO 0380
SOUTH AFRICA224 205
1246 Dany
MusungaieCharlotte De Jong
Douwe de JongJongaie Research
Medicross Pretoria West, 1st Floor, 551 WF Nkomo Street
Pretoria, GAUTENG 0183
SOUTH AFRICA141 129
1247 Haylene Nell Corli Marx Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital 260 248
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Zarinah Mohamed
Maria Pretorius
Matthys
Basson(Previous
SubI)
Precious
Garnett(Previous
SubI)
Rehana
Loghdey(Previous
SubI)
Catharina
Pretorius(Previous
SubI)
Mirna
Siebert(Previous
SubI)Clinical
c/o Mike Pienaar Boulevard & Frans Conradie Avenue, Bellville
Cape Town, WESTERN CAPE 7530
SOUTH AFRICA
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TURKEY
Number of Sites (Per Country ): 9
Number of Subjects Screened (Per Country ): 500
Number of Subjects Randomized/Entered (Per Country ): 487
Coordinating Investigator:
<None Entered>
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1205 Serhat Unal Murat Akova
Mine Durusu
Tanriover
Ahmet InkayaHacettepe Universitesi Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Sihhiye
Ankara, 06230
TURKEY80 79
1207 Ismail Balik Irem Akdemir Kalkan
Mehmet Birengel
Gule Cinar
Ezgi GultenAnkara Universitesi Tip Fakultesi, Ibni Sina Hastanesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Sihhiye
Ankara, 06230
TURKEY69 67
1208 Iftihar Koksal Yildiz Okuturlar
Alpay
Yesilaltay(Previous
SubI)Acibadem Atakent Hastanesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Birimi
Kucukcekmece
Istanbul, 34303
TURKEY55 54
1209 Sedat Altin Gulsah Gunluoglu
Dery a Hircin Cenger
Kerem TurkmenIstanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim
Arastirma Hastanesi
Zeytinburnu
Istanbul, 34020
TURKEY21 20
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1210 Ali Mert Mesut Yilmaz Medipol Mega Universite Hastanesi
Bagcilar
Istanbul, 34214
TURKEY62 62
1212 Oguz Karabay Abdulkadir Aydin
Ertugrul Guclu
Asli VatanSakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazari
Sakarya, 54100
TURKEY36 35
1213 Omer Tabak Hazal Erdem
Bilgul MeteIstanbul Universitesi -Cerrahpasa, Cerrahpasa Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Fatih
Istanbul, 34098
TURKEY60 55
1214 Serap
Simsek -YavuzCagla Keskin Saritas Istanbul Universitesi Istanbul Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Fatih
Istanbul, 34093
TURKEY55 54
1217 Sila Akhan Sonay Arslan Kocaeli Universitesi Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Umuttepe
Kocaeli, 41380
TURKEY62 61
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UNITED STATES
Number of Sites (Per Country ): 131
Number of Subjects Screened (Per Country ): 37413
Number of Subjects Randomized/Entered (Per Country ): 34859
Coordinating Investigator:
Stephen Thomas
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1001 Mark Mulligan Elisabeth Cohen
Tamia Davis
Andrew Fleming
Heather Givans
Ramin Herati
Angelica Kottkamp
Alexander
McMeeking
Mary Olson
Lalitha Parameswaran
Purvi Parikh
Rebecca Pellett
Madan
Vanessa Raabe
Bo Shopsin
Janine Sullivan
Robert Ulrich
Elizabeth Veneskey
Mahija Vucetovic
Mila
Ortigoza(Previous
SubI)
Kiana
Piedrahita(Previous NYU Langone Health
Schwartz Health Care Center
530 First Ave, 12th Fl
New York, NEW YORK 10016
UNITED STATES148 112
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Adam
Ratner(Previous
SubI)
1002 Kathleen Neuzil Kirsten Lyke
Monica McArthur
Justin Ortiz
Rekha Rapaka
Meagan
Dem ing(Previous
SubI)University of Maryland, Center for Vaccine Development and Global
Health
685 W. Baltimore St., HSF I, 4th Fl
Baltimore, MARYLAND 21201
UNITED STATES87 56
1003 Edward Walsh Ann Falsey
Mary rose
Laguio -Vila
Emil LeshoRochester Regional Health/Rochester General Hospital
Infectious Disease Dept.
1425 Portland Ave
Rochester, NY 14621
UNITED STATES209 167
1005 Matthew Davis Jenna Baer
Chelsea Bork
Michelle Burgett
Therese Dayton
Kathleen Ebeling
Victoria Fink
Jennifer Foley
Geesue Hah
Deborah Hodges
Sarah Ingalsbe -Geno
Mackay Kanaley
Patricia Larrabee
Joseph Mann
Abigail Miller
Julie MooneyRochester Clinical Research, Inc.
500 Helendale Rd, L20
Rochester, NY 14609
UNITED STATES442 427
Rochester Clinical Research, Inc.
500 Helendale Rd, Ste 265
Rochester, NEW YORK 14609
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Katherine
Pagenkemper
Jennifer Rowlinson
Tammi Shlotzhauer
Sally Thomas
Susan Willer
Jaclyn Zona
Zerina Zornic
Julie
Callahan(Previous
SubI)
Cristina
Cramer -Mills(Previou
s SubI)
Kara
Cristales(Previous
SubI)
Diana
Kailburn(Prev ious
SubI)
Julie
Wentw orth(Previous
SubI)
1006 James Peterson Natalie Bee
Alexander Clark
Shana Eborn
Susan Edwards
Dan Henry
Heather Jackson
Gerald Kelty
Issac Pena -Renteria
Jacqueline RohrerJ. Lew is Research, Inc. / Foothill Family Clinic
2295 Foothill Dr
Salt Lake City, UT 84109
UNITED STATES296 275
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Jack Taylor
1007 Robert Frenck David Bernstein
Rebecca Brady
Kristen Buschle
Michelle Dickey
Grant Paulsen
Felicia Scaggs Huang
Paul Spearman
Eleanor WiddiceCincinnati Children's Hospital Medical Center
Cincinnati Center for Clinica l Research (CCCR)
619 Oak St
Cincinnati, OH 45206
UNITED STATES660 586
Cincinnati Children's Hospital Medical Center
Gam ble Program for Clinical Studies
3333 Burnet Ave, MLC 6014
Cincinnati, OH 45229 -3039
UNITED STATES
1008 Timothy
JenningsTonya Clausen
Siddharth Kaul
Anthony Margherita
Stacey Miner
Brittany Nguyen
Ann Patek
Fredric Prater
Dawn Ringling
Richard Summa
Terry Weis
Alaina YarberClinical Research Professionals
17998 Chesterfield Airport Rd, Ste 100
Chesterfield, MO 63005
UNITED STATES942 934
1009 Shane
ChristensenHolly Anderson
Emily Bloomquist
Ross Brunetti
Thomas Conner
Gina Cox
Diana Grazulis
Wesley Lewis
James LongeJ. Lew is Research, Inc. / Foothill Family Clinic South
6360 S 3000 E, Ste 100
Salt Lake City, UT 84121
UNITED STATES414 392
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Christopher Matich
Bryan Nelson
Emily Raming
Sarah Scott
John Witbeck
Stephen Wood
1011 Susann Varano Mandesha Bendolph
Joan Boyer
Lauren Calgreen
Adina Hodges
Gail Hopkins
Patrice Lauture
Rachel Pierce
Holly SpainClinical Research Consulting, LLC
2080 Bridgeport Ave
Milford, CT 06460
UNITED STATES236 226
1012 Matthew Doust Nathan Alderson
Stephanie Catanzaro
Sandra Erickson
Shauna Harrell
Shana Harshell
Denise Sample
Dhwani Shah
Jennifer
Burgdorf(Previous
SubI)
Steven
Siwek(Previous SubI)
Sahara Vega(Previous
SubI)HOPE Research Institute
3900 E. Camelback Rd, Ste 125, 130 & 135
Phoenix, AZ 85018
UNITED STATES188 175
The Pain Center of Arizona
3900 E. Camelback Rd, Ste 190
Phoenix, AZ 85018
UNITED STATES
1013 Michael Dever Chanel Adams
Patricia Brow n
Joan CutilloClinical Neuroscience Solutions, Inc
618 E. S St, Ste 100
Orlando, FL 32801882 830
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Letitia Griffin
Linda Harper
Rebecca Klipper
Robert Molpus
Priya Moorhouse
Penny O'Neal
Deborah Renner
William Schesser
Felipe Suplicy
Geraldine
Marino(Previous
SubI)UNITED STATES
1015 Elizabeth
BarnettSacha Al Hassan
Deepa Anbumani
Kanika Bisht
Tori Blot
Ellen Cooper
Ridiane Denis
Ycar Devis
Faye Huang
Mona Lauture
Dayeun Lee
Debra McLaud
Carole Moloney
Casey Norton
Stephen Pelton
Vishakha Sabharwal
Scarlett Salerno
Javier Sanchez
Yuri Kim(Previous
SubI)
Mary Walsh(Previous Boston Medical Center
1 Boston Medical Center Pl., Shapiro Bldg. 9th Fl.
Boston, MA 02118
UNITED STATES264 260
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
1016 Daniel Finn Ashley Bennett
Melanie Bishop
Lindsay Blackmon
Stanley Block
Christal Denton
Lisa Dones
Whitney Downs
Rebecca Findlay
Kayla Hamilton
James Hedrick
Erica Koch
Kali Lewis
Brittany Lisby
Wendy Mattingly
Michelle Newton
Martha Osbourn
Lea Rust
Robert Smith
Monica Strenecky
Ronald Tyler
Shannon Woods
Tabitha Yates
Abby
O'Bryan -Wimsett(Pre
vious SubI)
Andrea
Yates(Previous SubI)Kentucky Pediatric/ Adult Research
201 S 5th St
Bardstown, KENTUCKY 40004
UNITED STATES386 371
1018 Veronica
FragosoShakira Barr
Teresa Becker
Lisa Hollow ay
Tracy Kow alskiTexas Center for Drug Development, Inc.
6550 Mapleridge St, Ste 201, 206, 216, 220
Houston, TEXAS 77081351 296
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Cecilia
McKeown -Biagas
Vicki Miller
Chen -Ho Yang
Blanca
Gom ez(Previous
SubI)
Odette
Kourouma(Previous
SubI)UNITED STATES
1019 Charles
AndrewsJohn Holcomb Diagnostics Research Group
4410 Medical Dr, Ste 360
San Antonio, TEXAS 78229
UNITED STATES323 305
1021 John Rubino Warner Edmundson
Tina Harris
William Jacobs
Douglas Short
Adeel Siddiqui
Stephanie Stoneback
Sarah UtechPMG Research of Raleigh, LLC
3521 Haw orth Dr, Ste 100
Raleigh, NC 27609
UNITED STATES252 248
1022 Steven Kaster Kathryn Eren
Linda Galvan
Patricia Garland
Jason Lake
Jovana Munos
Cathy Jo Roozen
Lauryn Wilson
Rebecca Woolston
Diane Davis(Previous
SubI)Wenatchee Valley Hospital
Clinical Research Department
820 N Chelan Ave
Wenatchee, WA 98801
UNITED STATES176 166
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Eliza
Zuniga(Previous
SubI)
1024 Christopher
LucastiDawn Paone South Jersey Infectious Disease
730 Shore Rd
Somers Point, NJ 08244
UNITED STATES132 124
1027 Alexander
MurrayLeanna Cutchins
William Harris
Randal Von Seggern
Susanne
Stuckey(Previous
SubI)
Richard
Tisovec(Previous
SubI)Pharm Quest
806 Green Valley Rd, Ste 305
Greensboro, NC 27408
UNITED STATES217 212
1028 Michael
LillestolJamie Brown
Karissa EmersonLillestol Research LLC
4450 31st Ave S, Ste 101
Fargo, ND 58104
UNITED STATES296 286
1030 Robert Salata Jalal-Deen Armiyaw
Reem Azem
James Capon
Alyssa Drosdak
Scott Fulton
Eduarda Grinsztejn
Joao
Claire Irons
Bianca Islam
Matthew MirskyUniversity Hospitals Cleveland Medical Center
11100 Euclid Ave
Cleveland, OH 44106
UNITED STATES158 153
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Laura Schapiro
Christina
Thoonkuzhy
George Yendewa
Elie Saade(Previous
SubI)
1036 Marcus Lee Robert Nichols
Diane SmithTrinity Clinical Research
709 NW Atlantic St
Tullahoma, TN 37388
UNITED STATES145 129
1037 Lisa Usdan Codi Anthony
Valerie Arnold
Linda Byrd
Patricia Cunningham
Courtney Hale
Lora McGill
Carolyn
ScatamacchiaClinical Neuroscience Solutions, Inc.
6401 Poplar Ave, Ste 420
Mem phis, TN 38119
UNITED STATES360 341
1038 Rick Whiles Anna Bays
Roger Begley
Andrew Brockmyre
Robert Rutherford
Ashley Smith
Pamela WrightHolston Medical Group
240 Medical Park Blvd, Ste 2600
Bristol, TN 37620
UNITED STATES141 127
1039 Gretchen Crook Jennifer Beanblossom
Kristen
Hansen -Peterm an
Sarah Higgs
Camille Horony
Linda NguyenARC Clinical Research at Wilson Parke
11714 Wilson Parke Ave., Ste 150
Austin, TX 78726
UNITED STATES334 308
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Ana Paez
Bandana Risal
Amy Siegel(Previous
SubI)
1042 William Seger Oluwatosin
Akingbala
Mohammed Antwi
Elizabeth Boydston
Tisha Davis
Deborah Devlin
Melody Dufrene
Allison Green
Alma Guel
Katherine Hollie
Anthony Kim
Samantha Loudermilk
Virginia Loudermilk
Kimberly Pullen
Abdur Rafay Qadri
Ben Seger
Maria Seger
Jean Seignon
Crystal Starr
Tasha Todd
John Villegas
Alena
Mitchell(Previous
SubI)Benchmark Research
4504 Boat Club Rd, Ste #400A
Fort Worth, TX 76135
UNITED STATES269 226
Texas Health Family Care
4504 Boat Club Rd, Ste 800
Fort Worth, TX 76135
UNITED STATES
1044 Aaron Hartman Raymond Decker
Rachel MartinVirginia Research Center LLC
13911 St. Francis Blvd., Ste 101
Midlothian, VA 23114385 378
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
UNITED STATES
1046 Ernest Hendrix Maria Acelajado
Onoya
Matthew Caldwell
Matthew HanserdNorth Alabama Research Center, LLC
721 W Market St, Ste B
Athens, AL 35611
UNITED STATES348 337
1047 James
McMurrayMichael Carter
Timothy Howard
Tiffany LozovskyMedical Affiliated Research Center
303 Williams Ave, Ste 511
Huntsville, AL 35801
UNITED STATES332 317
1048 Abram Burgher Nathan Alderson
Arthur Cook
Bettie Corcoran
Matthew Doust
Norma Frederick
Scarlett Hammett
Shauna Harrell
Ann Marie Milliken
Mary beth
Barcome(Previous
SubI)
Stephanie
Catanzaro(Previous
SubI)
Ramoun
Jones(Previous SubI)HOPE Research Institute
2525 W. Greenw ay Rd, Ste 220
Phoenix, AZ 85023
UNITED STATES133 127
HOPE Research Institute
2525 W. Greenw ay Rd, Ste 250
Phoenix, AZ 85023
UNITED STATES
1052 Suzanne Fussell Cynthia Chao
Alicia Delgado
Jessica Fox
Joseph Iw uajoku
Samir MehtaLong Beach Clinical Trials Services Inc.
2403 Atlantic Ave
Long Beach, CA 90806
UNITED STATES178 159
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Tamira Wade
Viviana
Gonzalez(Previous
SubI)
1054 Mark Leibowitz Rea Cruz Abaniel
Juan Frias
Robert Jenders
John Nelson
Parvin Syal
Sharon
Kelly(Previous SubI)National Research Institute
2010 Wilshire Blvd., Ste 302 and 809
Los Angeles, CA 90057
UNITED STATES214 182
1055 Helen Stacey Mark Christiansen
Stephanie Kim
Catherine Morimoto
Lana Norman
Meaghan Saint
Leonard
Chuck(Previous SubI)Diablo Clinical Research, Inc.
2255 Ygnacio Valley Rd, Ste M
Walnut Creek, CA 94598
UNITED STATES244 237
1056 Jose Cardona Yisel Castro
Someillan
Evelio Sosa
Victoria
Roque(Previous SubI)Indago Research & Health Center, Inc.
3700 W 12th Ave, Ste 300
Hialeah, FL 33012
UNITED STATES643 613
1057 Fadi Chalhoub Susan Angel
Sujeeta Dhakhw a
Brett Gellers
Nandita Jones
John Joyce
Niketa KambleClinical Neuroscience Solutions, Inc.
5200 Belfort Rd, Ste 420
Jacksonville, FL 32256
UNITED STATES455 431
1066 David Butuk Janelle Barney Solaris Clinical Research 434 425
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Janaie Bounsana
Erin Brennan
Melissa Conrad
Scott Frisby
Meredith Mangum
Paige McKenzie
Kaylee Ruckrigl1525 E Leigh Field Dr, # 100
Meridian, ID 83646
UNITED STATES
1068 Andrew Gentry David King
Christopher Lumsden
Susan Meyer
Melissa Pew
Rebecca Rassi
Mark WintonBozeman Health Deaconess Hospital dba Bozeman Health Clinical
Research
915 Highland Blvd
Bozeman, MT 59715
UNITED STATES118 116
1071 Michael Dunn Ronald Anderson
John Hallgren
Brian Hollis
Rudolf KotulaQuality Clinical Research, Inc.
10040 Regency Cr, Ste 375
Omaha, NEBRASKA 68114
UNITED STATES249 225
1072 Randle
MiddletonBrittanie Alexander
Courtney Carter
Misty Dixon
Charlotte Edmondson
Holly Gipson
Heather Mahoney
Nafisa Neighbors
Lauren Stiles
Joyce Todd
Terina Weir
Reba LuAnne
Boggs(Previous SubI)Optimal Research, LLC
2089 Cecil Ashburn Dr, Ste 203
Huntsville, AL 35802
UNITED STATES101 99
1073 Corey Anderson Lisa Dean Alliance for Multispecialty Research, LLC 130 116
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Naom i Devine
Georgina
Lopez- Wood
Tasha Marriott
Ashley Perez
James Ramsey
Cecilia Tanori
David Tatelbaum
Victor
Salazar -Calderon(Pre
vious SubI)
Nathan
Tauta(Previous SubI)1492 S Mill Ave, Ste 312
Tempe, ARIZONA 85281
UNITED STATES
1077 Suchet Patel Caitlin Burford
Kimberly DeSantis
Michael Federico
Dem etrios Gasparis
Lazarus Gehring
James Holler
Eric Lorraine
Katherine Macarak
Rekha Patel
John Perry
Duncan Sze -TuMeridian Clinical Research
415 Hooper Rd
Endw ell, NEW YORK 13760
UNITED STATES298 287
Meridian Clinical Research LLC
409 Hooper Rd
Endw ell, NEW YORK 13760
UNITED STATES
1079 George Raad Roby n Glancy
John Sensenbrenner
Laura Butler(Previous
SubI)
Kam eron
Dugat(Previous SubI)
Zachary
Larmore(Previous PMG Research of Charlotte LLC
1700 Abbey Place, Ste 201
Charlotte, NC 28209
UNITED STATES316 299
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Edward
Mogabgab(Previous
SubI)
Donald
Morrison(Previous
SubI)
1080 Sylvia Shoffner Scott Bilbro
Susan Crittenden
Garett Franklin
Sujatha Raman
Derek Schroder
Nicole
Ando(Previous SubI)
Samantha
Kiker(Previous SubI)
Amanda
Reed(Previous SubI)
Savannah
Shultz(Previous SubI)
Maurice
Smith(Previous SubI)PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
530 New Waverly Place, Ste 200A
Cary, NC 27518
UNITED STATES222 212
1081 Michael Butcher Julia Froschauer
James Fry
Gayle Hennekes
Diane
Broadnax(Previous
SubI)
Rachel
Crabtree(Previous
SubI)
Karen Sterling Research Group, Ltd.
2230 Auburn Ave, Level B
Cincinnati, OH 45219
UNITED STATES209 197
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Freudemann(Previous
SubI)
Marcel
Lanton(Previous
SubI)
Donna
Percy(Previous SubI)
Jeanne
Piccola(Previous
SubI)
Christina
Roedersheimer(Previ
ous SubI)
Phillip Ross(Previous
SubI)
1082 William Smith Sarah Campbell
Richard Gibson
Savannah Kidd
Elizabeth Parker
Jennifer Winbigler
Katherine
Buckner(Previous
SubI)
Talya
Thomas(Previous
SubI)Alliance for Multispecialty Research, LLC
1924 Alcoa Hwy, 4 and 5 Nw
Knoxville, TENNESSEE 37920
UNITED STATES224 203
Alliance for Multispecialty Research, LLC.
801 N. Weisgarber Rd, Ste 100
Knoxville, TN 37909
UNITED STATES
1083 Laurence Chu Maria Barrientes
Lamar Box
Christian Casas
Ruth Michelle
Chouteau
Lauren ChristalBenchmark Research
3100 Red River St, Ste 1
Austin, TX 78705
UNITED STATES282 245
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Katherine Davis
Tambra Dora
Cindy Duran
Pamela Fidler
Ruth Fitch
Brooke Harris
Lisa Johnson
Isaiah Knight
Jennifer Leyva
Michelle Listz
Jennifer Montes
Javier Perez
Marisol Ramos
Jessica Ruff
Dean Skiles
Sean Turnbow
Francesca Vigil
Breana Wade
Jennifer
Bacchi(Previous
SubI)
Taylor
Bartlett(Previous
SubI)
Selena
Bermudez(Previous
SubI)
Martha
Clark(Previous SubI)
Pamela
Conley(Previous
SubI)
Clara Loza(Previous
SubI)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Kelly
Weber(Previous
SubI)
1084 Douglas
DenhamAyoade Avworo
Maristelle Co
Parke Hedges
Matthew Korte
Mary Perez -Jenkins
Cynthia Ramos
Thomas Weiss
Darlington
Akahara(Previous
SubI)
Muhammad
Ata(Previous SubI)
Stephen
Brick(Previous SubI)
Cathleen
Chen(Previous SubI)
Graham
Ellis(Previous SubI)
Kimberly
Evans(Previous SubI)
Zachariah
Francois(Previous
SubI)
Anshumaan
Maharaj(Previous
SubI)
Clayton
Stone(Previous SubI)Clinical Trials of Texas, Inc.
(Storage Only)
5430 Fredericksburg Rd., Ste 601
San Antonio, TEXAS 78229
UNITED STATES597 545
Clinical Trials of Texas, Inc.
2nd SCA
5430 Fredericksburgs Rd, Trlr
San Antonio, TEXAS 78229
UNITED STATES
Clinical Trials of Texas, Inc.
5430 Fredericksburg Rd, Ste 200
San Antonio, TEXAS 78229
UNITED STATES
1085 Gregory Fuller Pamela Martin Ventavia Research Group, LLC 375 350
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Tracy Starnes 300 N Rufe Snow Dr
Keller, TX 76248
UNITED STATES
1087 Kevin Cannon Mesha Chadwick PMG Research of Wilmington, LLC
1907 Tradd Court
Wilm ington, NC 28401
UNITED STATES601 570
1088 John Earl Robert Hart
Jennifer Lail
Scott Polster
Heather Warta
Heather
Barnett(Previous
SubI)
Nicole
Everhart(Previous
SubI)
Ryan Parker(Previous
SubI)
Shai Perry(Previous
SubI)
Maranda
Rhudy(Previous
SubI)
Kristen
Sherrill(Previous
SubI)PMG Research of Hickory, LLC
221 13th Ave Pl NW, Ste 201
Hickory, NC 28601
UNITED STATES262 259
1089 Cecil Farrington Laura Kruchkow
Cortney Ledbetter
Kishan Maramraj
Robert McNeillPMG Research of Salisbury, LLC
410 Mocksville Ave
Salisbury, NC 28144353 323
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Jamie Myers
Kimberly PottsUNITED STATES
1090 Lisa Cohen
Wayne
Harper(Previous
PI)Lynn Eckert
Wayne Harper
Matthew Hong
Kendra Lisec
Priti Patel
Lori Bridges(Previous
SubI)
Lisa Cohen(Previous
SubI)
James
Earnhardt(Previous
SubI)
Adnan Nasir(Previous
SubI)
Amanda
Olsen(Previous SubI)
Douglas
Wadeson(Previous
SubI)M3 Wake Research, Inc.
3100 Duraleigh Rd, Ste 304
Raleigh, NC 27612
UNITED STATES562 511
1091 Samir Arora Rafe Bari
Brittany Biro
Brennan Brothers
Grazia Cannon
Jordan Carpenter
Jess DeMaria
Roger Faubel
Allison Forsythe
Sophia Gaines
Sridhar Guduri
Jessica HarpelAventiv Research Inc (Facility and Drug Shipment Address)
99 N. Brice Rd, Ste 260
Columbus, OHIO 43213
UNITED STATES468 448
Aventiv Research Inc.
99 N. Brice Rd, Ste 210
Columbus, OHIO 43213
UNITED STATES
090177e196a51b47\Approved\Approved On: 29-Mar-2021 02:31 (GMT)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Chelsea Hughes
Layne Mikanik
Lindsay Newton
Jessica Spear
Roy St. John
Danijela
Cvijetinovic(Previous
SubI)
Grace
Purkey(Previous
SubI)
1092 Rajesh Davit James Fry
Bruce Gebhardt
Gayle Hennekes
Victoria Hughes
Padm a Mangu
Debra Schroeck
Cynthia Wright
Joanne
Major(Previous SubI)Sterling Research Group, Ltd.
375 Glensprings Dr, 2nd Fl
Cincinnati, OH 45246
UNITED STATES277 267
1093 David Ensz Tavane Harrison
Allie Oplinger
Taylor
Bergh(Previous SubI)
Meagan
Miller(Previous SubI)Meridian Clinical Research, LLC
4802 Sunnybrook Dr
Sioux City, IOWA 51106
UNITED STATES227 194
1094 Murtaza
MussajiMohammad Siddiqui LinQ Research, LLC
11021 Shadow Creek Pkwy, Ste 102
Pearland, TEXAS 77584
UNITED STATES190 175
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1095 Paul Pickrell Brandi Chalman
Eileen Euperio
Lisa Johnson
Carol Linebarger
John Luna
Hussain Malbari
Stefanie Mott
Eugene Pampe
Andrew
Bell(Previous SubI)
Paige
Kenny(Previous
SubI)
Melissa
Winn(Previous SubI)Tekton Research, Inc.
4534 W Gate Blvd., Ste 110
Austin, TEXAS 78745
UNITED STATES315 285
1096 Van Tran Hany Ahmed
Hom ero Garza
Katherine LopezDr. Van Tran Family Practice
1919 N Loop W, Ste 218
Houston, TEXAS 77008
UNITED STATES393 361
Hany H. Ahmed, MD
1919 N Loop W, 140
Houston, TX 77008
UNITED STATES
Ventavia Research Group, LLC
1919 N Loop W, Ste 250
Houston, TX 77008
UNITED STATES
1097 Tom
ChristensenStephen Grubb
Steven PriceMain Street Physician's Care
3600 Sea Mountain Hwy, Ste C
Little River, SOUTH CAROLINA 29566123 117
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
UNITED STATES
1098 Salma Saiger Amy Dunn
Kiery McMullen
Moiz ShafiqSMS Clinical Research, LLC
1210 N Gallow ay Ave
Mesquite, TX 75149
UNITED STATES263 235
1101 Thomas Wolf Heather Diederich
John Dobleman
Renee Hochstein
Kylie Hutsell
Stacie Jarzynka
Bridget Ladwig
Shirley McLaurine
Nathan Neuberger
Christine Scheuring
Brandi Schulz
Andrea VerMaas
Jenny Belitz(Previous
SubI)
Colleen
Caliri(Previous SubI)
Jessica
Francis(Previous
SubI)
David
Garcia(Previous
SubI)
Lynnda
Schiermann(Previous
SubI)Methodist Physicians Clinic / CCT Research
350 W 23rd St
Frem ont, NE 68025
UNITED STATES120 116
1107 Harry Studdard Dana Bekurs
Katelyn HowardAlliance for Multispecialty Research, LLC
100 Memorial Hospital Dr, Annex Bldg, Ste -3B219 193
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Michael Ledet
Pamela Manley
Anna May
Carrie
Allenbach(Previous
SubI)Mobile, AL 36608
UNITED STATES
1109 Bruce Rankin Fadhel Alyunis
Vienna Bauer
Tasha Brocato
Daniel Campbell
Jennifer Cline
Claxton Copeland
Paula Daniel
Jeanette De Leon
Craig Dean
Jennifer Dittman
Szheckera Fearon
Shatonia Fields
Jessica Gilliam
Angela Hammerle
Eva-Maria Heurich
John Hill
Ryan Hobbick
Melissa Hodges
Ranie Hutchins
Taylor Martin
Clark Mason
Crystal Paccione
Vivek Rajasekhar
Antonio Rivera
Over Seijas
William Serrano
Steven ShinnDeLand Clinical Research Unit
860 Peachw ood Dr
DeLand, FLORIDA 32720
UNITED STATES558 526
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Diana Toney
Thais Truffa
Michelle Tutt
Amber Vasquez
Erika Wierzbicki
Christina
Isbell(Previous SubI)
Dhaneshwar
Oom row(Previous
SubI)
1110 Jeffrey Rosen Eric Gancedo
Monica Mauri
Jennifer Mokross
Jenny Montes De Oca
Pineda
Tamara Richards
Adam RosenAlliance for Multispecialty Research, LLC -Miami
370 Minorca Ave, Miami -Dade County, Coral Gables Section
Coral Gables, FLORIDA 33134
UNITED STATES380 350
Clinical Research of South Florida
370 Minorca Ave, 2nd Fl
Coral Gables, FL 33134
UNITED STATES
1111 Michael
StephensWilliam Davila
Sarah Graham
Mitchell Rothstein
Stephanie Wilder
Anne WittFleming Island Center for Clinical Research
1679 Eagle Harbor Pkwy, Ste D
Fleming Island, FL 32003
UNITED STATES207 198
1112 Nathan Segall Michelle Binns
Kimberly Cobb
Jon Finley
Jeffrey Jones
Susan Jones
Jennifer LeBrun
Nancy LevineClinical Research Atlanta
175 Country Club Dr, Bldg 100, Ste A
Stockbridge, GA 30281
UNITED STATES350 328
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Michelle Sowell
Cynthia Steele
Mildred Stull
Pamela Talbott
Donna Toepfer
Kwannda Whatley
Karen Yangapatty
Mustafa
Elhallaoui(Previous
SubI)
Tyra Gaines(Previous
SubI)
William
Osborne(Previous
SubI)
1114 Richard Glover Janelle Brown
Melissa Burton
Jordan Danby
Amber Grant
Roby n Hartvickson
Lisa Hemmelgarn
Troy Holdeman
Riley King
Marissa Mueller
Aaron Nguyen
Justin Phillips
Katherine
Saengerhausen
Stacy Slechta
Dylan Thom as
Shannon Thomas
Denae Villines
Eilleen WilbertAlliance for Multispecialty Research, LLC
700 Medical Center Dr, Ste 110
Newton, KANSAS 67114
UNITED STATES128 118
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Lindsey
Brew er(Previous
SubI)
Sheri
Duncan(Previous
SubI)
Jeri King(Previous
SubI)
Shannen
Lassiter(Previous
SubI)
Cayla
Lawless(Previous
SubI)
Jill
Longstaff(Previous
SubI)
Ragene
Moore(Previous
SubI)
Cindy
Thome(Previous
SubI)
1116 Paul Matherne Melissa Benke
Nancy Bladsacker
Sarah Bow en
Amy Caldwell
Ashley Dean -Reaves
Donald Gaddy
Nicole Guttierrez
Tiffany Payne
Connie Richardson
Wendy ShawMedPharmics, LLC
15190 Community Rd, Ste 300
Gulfport, MISSISSIPPI 39503
UNITED STATES326 293
MedPharmics, Limited Liability Company
15190 Community Rd., Ste 350
Gulfport, MISSISSIPPI 39503
UNITED STATES
090177e196a51b47\Approved\Approved On: 29-Mar-2021 02:31 (GMT)
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Laura Singley
Jessica Stahl
Kathrine
Gaddy(Previous
SubI)
Megan Hill(Previous
SubI)
Lindsay
Huckabee(Previous
SubI)
Heather
Lambert(Previous
SubI)
Valerie
Velasco(Previous
SubI)
Dimitri
Yanez(Previous SubI)
1117 Larkin
Wadsw orthJennifer Berry
Lauren Clement
Lyly Dang
Horacio MarafiotiSundance Clinical Research, LLC
711 Old Ballas Rd, Ste 105
St. Louis, MO 63141
UNITED STATES197 180
1118 Frank Eder Victoria Engler
Ryan Little
Jennifer Molstead
Heather
Rattenbury -Shaw
John TarboxMeridian Clinical Research, LLC
1290 Uppr Frnt St
Binghamton, NEW YORK 13901
UNITED STATES130 122
1120 Paul Bradley Jim Callis
Shannon Davis
Brandon EssinkMeridian Clinical Research, LLC
340 Eisenhower Dr, Ste 1200
Savannah, GA 31406434 345
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Amanda Lilienthal
Shanice
Bennett(Previous
SubI)
Anne
Crouch(Previous
SubI)
Brooke
Halpern(Previous
SubI)
Doungphon
Nelson(Previous
SubI)
Kay Lynn
Olmsted(Previous
SubI)UNITED STATES
1121 Daniel Brune Jessica Bonnette
Monica Brow n
Shannon Carter
Jennifer Dixon
Michael Downey
Jennifer Hartley
Jennifer Henz
Rachel Kilgus
Craig Koch
Christian
Regalado -Mathe ws
Danielle Scoles
Jared Smith
Christina Troxell
Sidney WollOptimal Research, LLC
4911 N. Executive Dr, 2nd Fl
Peoria, ILLINOIS 61614
UNITED STATES122 98
1122 Curtis Donskey Federico Perez VA Northeast Ohio Healthcare System 57 48
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Margaret Tiktin 10701 E Blvd.
Cleveland, OHIO 44106
UNITED STATES
1123 Brandon Essink Laura Falcone
Roni Gray
Cassandra Heisey
Linda Layton
Jay Meyer
Frederick Raiser
Akossiwa Yovogan
Jacob
Bumsted(Previous
SubI)
Kimberly
Mueller(Previous
SubI)
Tiffany
Nem ecek(Previous
SubI)Meridian Clinical Research
3319 N 107th St.
Omaha, NEBRASKA 68134
UNITED STATES522 489
1124 David Fried Jacqueline DiFazio
Patricia Feole
Helena Godley
Kristina Haughey
Lynne Haughey
Courtney Langlois
Amanda O'Neill
Johnna Pezzullo
Lisa Rameaka
Molly Savitzky
Ariana Stanton
Amanda Omega Medical Research
400 Bald Hill Rd
Warw ick, RHODE ISLAND 02886
UNITED STATES275 257
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Cole(Previous SubI)
1125 Charles Harper Sally Eppenbach
Alisha Kiepke
Cathy Laflan
Wendell Lewis
Brett Loseke
Chelsie Nutsch
Kari Uhlir
Keith VrbickyMeridian Clinical Research, LLC
1410 N 13th St, Ste 5
Norfolk, NE 68701
UNITED STATES255 217
1126 Nicola Klein Rebecca Alexander
Janelle Baires
Jessica Barraza
Latisha Burun
Christine Cash
Gail Cook
David Cooper
Jolynne Encarnacion
Douglas Ernst
Lauren Fontenot
LaVonne Freed
Sarah Kang
Rom a Kullar
Ludy Lemus
Eva Lowe
Lorrie Lowe
Nicole Makram
Shannon Mullen
Courtne y Oxandale
Ken Purdy
Sally Upadhyaya
Dana Weisshaar
Amy WiesnerKaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES326 319
Kaiser Permanente Santa Clara
710 Law rence Expy
Santa Clara, CALIFORNIA 95051
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Jeremy
Giese(Previous SubI)
Julia
Glanternik(Previous
SubI)
Lisa
Kennedy(Previous
SubI)
Rebekah
Kotyk(Previous SubI)
1127 Tracy Klein Nathan Bergkamp
Olivia Eagleson
Gregory Greer
Lisa Hemmelgarn
Diandra Henriques
Jill Hiebert
Denise Hole
Laura Holz
Terry Klein
Thomas Klein
Shannen Lassiter
Jill Longstaff
Jessie Matthe ws
Meenakshi Natesan
Loan Nguyen
Terry Poling
Christa Shue
Brenna Sprout
Cindy Thome
Dem etria Underw ood
Ariel Wilken
Gina Young
Sandra Alliance for Multispecialty Research, LLC
1709 S Rock Rd
Wichita, KS 67207
UNITED STATES114 100
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Blaylock(Previous
SubI)
Lynn Le(Previous
SubI)
Taylor
Simmons(Previous
SubI)
1128 Mark Koch Norma Escamilla
Isaac Watemberg
Patricia
Kaczmarski(Previous
SubI)
James Winn(Previous
SubI)Ventavia Research Group, LLC
1307 8th Ave, Ste 202
Fort Worth, TX 76104
UNITED STATES385 359
Ventavia Research Group, LLC
1307 8th Ave, Ste M1
Fort Worth, TX 76104
UNITED STATES
1129 Michael Koren Kenneth Aung -Din
Darlene Bartilucci
Janet Garvey
Jeffry Jacqmein
Alpa Patel
Mitchell Rothstein
Steven Toenjes
Carolyn TranJacksonville Center for Clinical Research
4085 University Blvd S, Ste 1
Jacksonville, FLORIDA 32216
UNITED STATES263 245
1130 Stephen
FortmannTara Beatty
Bryan Kauffman
Dorothy Kurdyla
Richard Mularski
Katie Sharff
Britta
Torgrimson -OjerioKaiser Permanente Northwest -Center for Health Research
3800 N Interstate Ave
Portland, OR 97227
UNITED STATES98 98
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Eric Walter
1131 William Randall Heather Goins
Ann Moell
Crystal Osman
Caitlyn Smith
Gilbert Templeton
Melissa
Botts(Previous SubI)
Zachariah
Kom on(Previous
SubI)
Kimberly
Lyons(Previous SubI)PriMED Clinical Research
948 Patterson Rd
Dayton, OHIO 45419
UNITED STATES302 269
1133 How ard
SchwartzMaria Companioni
Barbara Corral
Surisaday Mederos
Americo Padilla
Nelia Sanchez -Crespo
Jennifer Schwartz
Janet Sentil Tamayo
Peter VentreResearch Centers of America
7261 Sheridan St, Suites 210, 215, 310
Hollywood, FLORIDA 33024
UNITED STATES650 530
1134 Jonathan Wilson Robert Holmes
Josephine Purbrick
Danielle Reynolds
Ashley Schmidt
Brian Smith
Holly Smith
Andrew
Stebich(Previous
SubI)
Alissa PMG Research of Winston -Salem , LLC
1901 S. Haw thorne Rd, Ste 306
Winston -Salem, NC 27103
UNITED STATES438 417
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
VanDyke(Previous
SubI)
1135 Peter Winkle Riany Mirasol Cadag
Amina Haggag
Elizabeth LeeAnaheim Clinical Trials, LLC
1085 N. Harbor Blvd.
Anaheim, CA 92801
UNITED STATES566 513
Anaheim Clinical Trials, LLC
2441 W. La Palma Ave, Ste 140
Anaheim, CALIFORNIA 92801
UNITED STATES
1136 Michael Levin Melodie Armstrong
Julie Hussey
Marcy Kulic
Judith Salz(Previous
SubI)Wake Research -Clinical Research Center of Nevada, LLC
1022 E Sahara Ave
Las Vegas, NEVADA 89104
UNITED STATES111 100
1139 Emmanuel
WalterChristopher Clark
Jennifer Dougherty
Michael Smith
Geeta SwamyAccessioning Unit and Repository
2 Genome Court
Durham, NORTH CAROLINA 27710
UNITED STATES262 248
Clinical Research Pickett Road
3024 Pickett Rd, Durham County
Durham, NORTH CAROLINA 27705
UNITED STATES
Duke University Medicine Circle -Duke Early Phase Clinical Research
Unit
40 Duke Medicine Circle
Durham, NC 27710
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Duke Vaccine and Trials Unit
2608 Erwin Rd, Ste 210
Durham, NORTH CAROLINA 27705
UNITED STATES
1140 Stephen Thom asKathryn Anderson
Elizabeth
Asiago -Reddy
Donald Blair
Rachael Cavelli
Joseph Domachowske
Timothy Endy
Sriharsha Gowtham
Elizabeth Harausz
Kristopher PaolinoSUNY Upstate Medical University
Global Health Research Unit
4900 Broad Rd, Physician Ofc Bldg N, Ste 4U
Syracuse, NEW YORK 13215
UNITED STATES400 364
SUNY Upstate Medical University
Institute for Human Performance
505 Irving Ave, Clinical Research Unit
Syracuse, NEW YORK 13210
UNITED STATES
1141 Patricia
WinokurJeffery Meier
Elizabeth Morgan
Debra Pfab
Jack Stapleton
Laura StulkenUniversity of Iowa Hospitals & Clinics
200 Hawkins Dr
Iowa City, IA 52242
UNITED STATES265 252
University of Iowa Hospitals & Clinics Investigational Drug Servces
200 Hawkins Dr, 01284 PFP
Iowa City, IOWA 42242
UNITED STATES
1142 Richard Rupp Megan Berman
Cori Burkett
Laura Porterfield
Elizabeth
Ginn(Previous SubI)University of Texas Medical Branch
SIVS Clinical Trials Program, Primary Care Pavilion, 400 Harborside
Dr., Ste 126
Galveston, TEXAS 77555
UNITED STATES390 371
1145 Kawsar Talaat Rachel Adkinson
Kam al DhanjaniCenter for Immunization Research Inpatient Unit
Johns Hopkins Bayview Medical Center (JHBMC)113 102
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Anna Durbin
Brittany Feijoo
Palmtama Grier
Rachel Rokser
Brittany
Adjoodani(Previous
SubI)
Noreen
Hynes(Previous SubI)
Beulah
Sabundayo(Previous
SubI)301 Mason Lord Dr, 4300
Baltimore, MD 21224
UNITED STATES
1146 Robert Falcone Sonia Edw ards
Lisa Malak
Anthony
Frisoli(Previous SubI)
Christine
Hildebrand(Previous
SubI)Amici Clinical Research
34 E Somerset St
Raritan, NJ 08869
UNITED STATES394 370
1147 Julia
Garcia- DiazHailey Anderson
Julie Castex
Freda Dunhurst
Jenna Griffin
Samuel King
James McMullen
Melinda
Benvenuti(Previous
SubI)
Lisa
Fredenburg(Previous
SubI)Ochsner Clinic Foundation
1514 Jefferson Hwy
New Orleans, LA 70121
UNITED STATES339 318
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1149 Steven
ReynoldsGregory Bonomo
Haig Goenjian
Omid Omidvar
Lara Shirikjian
Seanglong Te
Lee
Dolow ich(Previous
SubI)Collaborative Neuroscience Research, LLC
2600 Redondo Ave, Ste 415
Long Beach, CA 90806
UNITED STATES344 320
Collaborative Neuroscience Research, LLC. -Investigator Site File
Location
12772 Valley View St, Ste 3
Garden Grove, CA 92845
UNITED STATES
Collborative Neuroscience Research, LLC. -Study Visits & IP
Shipping/Storage
2600 Redondo Ave, Ste 500
Long Beach, CA 90806
UNITED STATES
1150 Shelly Senders Sarah Ball
Elizabeth Bucchieri
Laura Caserta
Christopher
Fackelmann
Caitlin Fillioe
Kelly Kelmes
Jennifer McKinnon
Katie Passarell
Jill Sangree
Allison
Effron(Previous SubI)
Keili
Mistovich(Previous
SubI)
Eliza
Pereira(Previous Senders Pediatrics
2054 S Green Rd
South Euclid, OH 44121
UNITED STATES298 294
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
1152 Donald Brandon William Davis
Daniel LawlerCalifornia Research Foundation
4180 Ruffin Rd, Ste 255
San Diego, CALIFORNIA 92123 -1881
UNITED STATES753 733
1156 Hector
RodriguezArmando Acevedo
Armando Garcia
Yeniska Hall Nieves
Lizz L. Hernandez
Diaz
Iris Izquierdo
Elaine Martinez
Alina Monteagudo
Canto
Israel ZagalesAcevedo Clinical Research Associates
2400 Nw 54th St
Miami, FL 33142
UNITED STATES377 368
1157 Jamshid Saleh Marisol Angel
Corrales
Marla Clark
Emily Crews
Rafael Lupercio
Matthew Miles
Matthew Pohlmeyer
Sarah Sandberg
Mohamed Yassin
Ruba Zanaid
Candice
Cabading(Previous
SubI)
Stephanie
Clayton(Previous
SubI)Paradigm Clinical Research Center
3652 Eureka Way
Redding, CA 96001
UNITED STATES178 155
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Amber
Falconer(Previous
SubI)
Carmen
Flores(Previous SubI)
Alisha
Garcia(Previous
SubI)
Vicky
Martin(Previous
SubI)
1161 Darrell
HerringtonWarren Conway
Dacia Corder
Krystal Doucet
Priscilla Garcia
Kayla Gibbs
Mark
Hinojos -Zamora
Jaime Hyatt
Pricilla Percifield
Ivon Reveles
Vanessa Sanchez
Blanca Valdez
Melissa White
Cambree
Allison(Previous
SubI)
Cynthia
Dukes(Previous SubI)
Tina Goltl(Previous
SubI)
Elyza
Guerrero(Previous Benchmark Research.
3605 Executive Dr
San Angelo, TEXAS 76904
UNITED STATES43 33
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Omega
Hernandez(Previous
SubI)
Priscilla
Lozano(Previous
SubI)
Pete
Mendoza(Previous
SubI)
Sierra
Ramirez(Previous
SubI)
Jacquie
Rincon(Prev ious
SubI)
Shawnna
White(Previous SubI)
1162 Robert
RiesenbergMaria Johnson
Mark Lerman
Stanford Plavin
Leana WoodsideAtlanta Center for Medical Research
501 Fairburn Rd SW
Atlanta, GEORGIA 30331
UNITED STATES588 540
1163 George Bauer Michael Cotugno
Cynthia Dukes
Lois Eaglin
Stacey Howard
Brandon Illickal
Brenda Lawson
Kyra La wson
Jeffrey Segner
Edwin
Adamson(Previous Benchmark Research
4517 Veterans Memorial Blvd
Metairie, LOUISIANA 70006
UNITED STATES146 138
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Julie Bilich(Previous
SubI)
Kim Harper(Previous
SubI)
Charie
Hynes(Previous SubI)
1166 Mary Beth
ManningBrianna Arman
Nicole Baitt
Toby Briskin
Sarah Dzigiel
Jennifer Gaston
Brooke Glivar
Lisa Hoagland
Briana Jackson
Emma Landskroner
Denise Roadman
Joan Rothenberg
Brian Sharpe
Karly Tarase
Sharita
Tedder -Edwards
Amy
Maroun(Previous
SubI)
Devan Patel(Previous
SubI)
Megan
Sokolowski(Previous
SubI)Rapid Medical Research, Inc.
3619 Park E Dr, Ste 300
Cleveland, OH 44122
UNITED STATES107 100
1167 Emily
Moraw skiLisa Davis
Amanda DonohoHolston Medical Group
105 W Stone Dr, 3rd Fl, Ste 3B232 225
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Ashley Helton
Curtis Jantzi
Anna Johnson
David Morin
Lori Ray
Emily Whitaker
Shane
Daniell(Previous
SubI)
Joseph Ley(Previous
SubI)Kingsport, TN 37660
UNITED STATES
1168 Steven Cox Brandy Ball
Angela Genovese
Aja George
Shanda Gow er
Karen Hames
Avery Keller
Sharla Lister
Chalimar Rojo
Sharee Wright
Lindsay
Flaming(Previous
SubI)Lynn Institute of Norman
630 24th Ave Sw
Norman, OKLAHOMA 73069
UNITED STATES241 225
1169 Joseph Yozviak Kristen Cornell
Thomas Eames
Brian Friel
Timothy Friel
Marcelo Gareca
Margaret
Hoffman -Terry
Matthew Karpowicz
Terry KloiberLehigh Valley Health Network/Network Office of Research and
Innovation
17th & Chew Streets
Allentown, PA 18102
UNITED STATES76 68
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Mark Knouse
Arun Mancheril
Hugh Marsh
Jean Novak
Andrew Orzel
Carla Rossi
Amy Slenker
Nicholas Trask
1170 Mezgebe Berhe Christopher Bettacchi
Jessica Caldwell
Emma Dishner
Erin Duhaime
Kevin Golden
Clinton Haley
Bailey Isenberg
Misty Kell
Bryan King
Tammy Morgan
Uriel Sandkovsky
Rahaf Al
Masri(Previous SubI)North Texas Infectious Diseases Consultants, P.A.
3409 Worth St, Ste 710, 725, 740
Dallas, TEXAS 75246
UNITED STATES494 465
1171 Earl Martin Carolina Deandres
Muhammad Irfan
Earl Martin
Monica Murray
Amy Starr
Insiya
Valika(Previous
SubI)DM Clinical Research
13406 Medical Complex Dr, Ste 53
Tom ball, TX 77375
UNITED STATES307 286
Martin Diagnostic Clinic
710 Law rence St
Tom ball, TX 77375
UNITED STATES
1174 Donald Poretz Amber Edelman Clinical Alliance for Research & Education -Infectious Diseases, LLC 71 67
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Malika Welborn
David Wheeler(CARE -ID)
3289 Woodburn Rd, Ste 250
Annandale, VA 22003
UNITED STATES
Infectious Diseases Physicians, LLC
3289 Woodburn Rd, Ste 200
Annandale, VA 22003
UNITED STATES
1177 David
Fitz-PatrickCindy Pau
Sian SmowtonEast-West Medical Research Institute
1585 Kapiolani Blvd, Ste 1500
Honolulu, HI 96814
UNITED STATES565 561
1178 Stephan Sharp Michael Caldw ell
Stacy Cox
Michael Hutson
Deborah Jamison
Leanne Martin
Lois McClure
Kathryn McNally
Audrey Quickel
Linda Schipani
Allison Sochovka
Robert Stokes
Wendy Tidw ell
Deidre
Lanier(Previous SubI)Clinical Research Associates, Inc.
1500 Church St, Ste 100
Nashville, TN 37203
UNITED STATES317 306
1179 Steven Katzman Michael Potes
Khalid RaoMichigan Center for Medical Research
30160 Orchard Lake Rd
Farm ington Hills, MI 48334
UNITED STATES174 171
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1204 Judith Aberg Deena Altman
Tarashon Broomes
Michelle Cespedes
Francesca Cossarini
Alina Jen
Sean Liu
Farah Rahman
Erika Maria Reategui
Schwarz
Dana Mazo(Previous
SubI)
Sondra
Middleton(Previous
SubI)Icahn School of Medicine at Mount Sinai
17 E 102nd st, 8th fl
New York, NY 10029
UNITED STATES287 272
Icahn School of M edicine at Mount Sinai -Investigational Drug Service
1450 Madison Ave, Annenberg B2, Rm 204
New York, NY 10029
UNITED STATES
1218 Laura Hammitt Laura Brown
James Campbell
Jane Halpern
Nina Ritchie
Kristen Roessler
Daniel VandeRiet
Robert WeatherholtzJohns Hopkins Center for American Indian Health
308 Kuper St.
Whiteriver, ARIZONA 85941
UNITED STATES58 53
Whiteriver Indian Hospital
200 W Hospital Dr
Whiteriver, ARIZONA 85941
UNITED STATES
Whiteriver Indian Hospital -Garrett Building
400 W. Apache Dr
Whiteriver, ARIZONA 85941
UNITED STATES
1219 Laura Hammitt Laura Brown
James Campbell
Jane Halpern
Nina RitchieChinle Comprehensive Health Care Facility
US Hwy 191 and Hospital Rd
Chinle, ARIZONA 86503
UNITED STATES60 58
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Kristen Roessler
Daniel VandeRiet
Robert WeatherholtzJohns Hopkins Center for American Indian Health
US Hwy 191
Chinle, ARIZONA 86503
UNITED STATES
1220 Laura Hammitt Laura Brown
James Campbell
Jane Halpern
Nina Ritchie
Kristen Roessler
Daniel VandeRiet
Robert WeatherholtzJohns Hopkins Center for American Indian Health
3 Cottonw ood St
Shiprock, NEW MEXICO 87420
UNITED STATES65 53
Northern Navajo Medical Center
US HWY 491 N
Shiprock, NEW MEXICO 87420
UNITED STATES
1221 Laura Hammitt Laura Brown
James Campbell
Jane Halpern
Nina Ritchie
Kristen Roessler
Daniel VandeRiet
Robert WeatherholtzGallup Indian Medical Center
516 E Nizhoni Blvd
Gallup, NEW MEXICO 87301
UNITED STATES94 87
Johns Hopkins Center for American Indian Health
501 E. Nizhoni Blvd, Ste B
Gallup, NEW MEXICO 87301
UNITED STATES
1223 Onyema
OgbuaguLaurie Andrews
Melissa Campbell
Jessica Tuan
Thilinie
Bandaranayake(Previ
ous SubI)
Frances
Santiago(Previous Yale Center for Clinical Investigations (CSRU)
2 Church St S, Ste 114
New Haven, CT 06519
UNITED STATES284 266
Yale University
School of Medicine
135 College St, Ste 392
New Haven, CT 06510
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI) UNITED STATES
Yale -New Haven Hospital
55 Park St, LL -15
New Haven, CT 06511
UNITED STATES
1224 Larry Odekirk Cherie Castro
Christina Gallegos
Veronica Gonzales
John McLaughlin
Mark Nathanson
Kelly Radin
Kristine RauschLynn Institute of Denver
1411 S. Potomac St, Ste 420
Aurora, CO 80012
UNITED STATES187 183
1232 Jeffrey Kingsley April Pixler IACT Health
800 Talbotton Rd
Columbus, GA 31904
UNITED STATES434 399
1235 John Vanchiere Pat Bass
Paul Cooper
Louis ScottLSUHSC -Shreveport
1501 Kings Hwy
Shreveport, LA 71103
UNITED STATES250 244
LSUHSC -Shreveport Clinical Trials Office
1801 Fairfield Ave, Ste 203
Shreveport, LA 71101
UNITED STATES
1248 Mohamed
Al-IbrahimRebecca Coppola
Katarzyna Fraczek
Michael Morgan
Dana Rasmussen
Lisa ThompsonPharm aron CPC, Inc.
800 W Baltimore St, 5th and 6th Fl
Baltimore, MARYLAND 21201
UNITED STATES252 218
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Paolo
DePetrillo(Previous
SubI)
Albert
Fuzayl(Previous
SubI)
1251 Hayes Williams Gary Boyd
LaShondra Cade
Aileen Cunningham
Connie Moya
Sita Patel
Mitzi RobertsBirmingham Clinical Research Unit
2017 Canyon Rd, Ste 41
Birmingham, ALABAMA 35216
UNITED STATES264 252
1252 Stephen Grubb Tom Christensen
Krystal Hill
Steven PriceMain Street Physician's Care
3612 Mitchell St
Loris, SOUTH CAROLINA 29569
UNITED STATES40 38
1254 Robert Heller Monica Lee
Michael PakdamanBayview Research Group
12626 Riverside Dr, Ste 404
Valley Village, CALIFORNIA 91607
UNITED STATES213 201
1258 Martin Schear Missy Chapman
Amy Hitchler
Tammy LillyDayton Clinical Research
1100 Salem Ave
Dayton, OH 45406
UNITED STATES74 72
1260 Robert Finberg Carol Ciccarelli
Mary Dawn Co
Amanda Davies
Kaethe Giaquinto
John Haran
Danielle KokoskiUMass Memorial Me dical Center - University Campus
55 Lake Ave N
Worcester, MASSACHUSETTS 01655
UNITED STATES135 130
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Juan Perez Velazquez
Bethany Trainor
Jennifer Wang
Mireya Wessolossky
Jaclyn
Longtine(Previous
SubI)
Karen
Longtine(Previous
SubI)
1261 Carla
GreenbaumSandra Lord
Michael Richter
Dana VanBueckenBenaroya Research Institute at Virginia Mason
925 Seneca St
Seattle, WA 98101
UNITED STATES83 82
1264 Timothy
AlbertsonRoblee Allen
Stuart Cohen
Angela Haczku
Richart Harper
Nicholas Kenyon
Brian Morrissey
Susan Murin
Justin Oldham
Christian Sandrock
Nam ita Sood
Ken YonedaUC Davis Medical Center
2315 Stockton Blvd
Sacramento, CA 95817
UNITED STATES227 224
1265 William Tow nerJennifer Chang
Celia Garza -Halstead
Vikas Jayadeva
Marc La Riviere
Yu Fon LeeKaiser Permanente Los Angeles Medical Center
Edgemont Medical Offices
1526 N Edgemont St
Los Angeles, CA 90027
UNITED STATES183 174
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Kaiser Permanente Los Angeles Medical Center
4867 W Sunset Blvd
Los Angeles, CALIFORNIA 90027
UNITED STATES
1269 Teresa Sligh Parul Desai
Scott SlighProvidence Clinical Research
6400 Laurel Canyon Blvd, Ste 300A
North Hollywood, CA 91606
UNITED STATES143 135
1270 Nicola Klein Rebecca Alexander
Janelle Baires
Jessica Barraza
Latisha Burun
Christine Cash
Gail Cook
David Cooper
Jolynne Encarnacion
Douglas Ernst
Lauren Fontenot
LaVonne Freed
Jeremy Giese
Sarah Kang
Lisa Kennedy
Rom a Kullar
Ludy Lemus
Eva Lowe
Lorrie Lowe
Nicole Makram
Shannon Mullen
Courtney Oxandale
Ken Purdy
Sally Upadhyaya
Dana WeisshaarKaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES244 233
Kaiser Permanente Santa Clara
710 Law rence Expy
Santa Clara, CALIFORNIA 95051
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Amy Wiesner
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16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 1List of Contract Research Organizations and Vendors
CRO or Vendor Name and Address( es) Service Conducted
Almac Clinical Services LLC
25 Fretz Road
Souderton PA 18964
United StatesClinical Research Pharmacist Pfizer
Investiga tional Product Coordinat or
Support
C3i Solutions
410 Horsham Road
Horsham, PA 19044
United StatesMedical Escalation and IRT Unblinding
Suppo rt
CRF Health Management L imited, an
affiliate of Bracket Global LLC
Ground Floor
Waterfront Building
Manbre Road
Hammersmith
Londo n
W6 9RH
United KingdomSubject D ata Assessment Tool (eDiary )
and Data Collection
DrugDev Inc.(anIQVIA com pany)
228 N. Market Street
Frederick , MD 21701
Unite d StateseConsent Services
Eliassen Group
55 Walkers Brook Drive, 6thFloor
Reading, MA 01867
United State sStatistical Programming
ICON Clinical R esearch Limited
South County Business Park
Leopardstown, Dublin 18
IrelandProject Man agement
Study Manage ment
Investiga tor Si te Monitoring
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16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 2CRO or Vendor Name and Address( es) Service Conducted
Klinar CRO
Kazım Özalp Mah. Şairler. Sok. 17/3-4
06680 Cankay a
Ankara
TurkeySMO for Study Coordinators
MMS Holdings Inc.
6880 Commer ce Boulevard
Canton, MI 48187
United StatesMedical Writing ( Clinical Study Report
Narratives)
Premier R esearch Group Limited
234 C opeland Street Suite 400
Quincy, MA 02169
United State sClinical Trial Coding, Dictionary
Mapping and Mainten ance
WCG-T HREEWIRE Inc.
7500 Fly ing Cl oud Drive
Suite 300
Eden Prairie, MN 55344
United State sClinical R esearch Coordina tor Support
for Invest igator Sites
VerilyLife Scie nces LLC
269 East Grand Ave nue
South San Francisco, C A 94080
United Sta tesRecruitment Services
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