125742 S1 M5 5351 c4591001 fa interim investigators

Document text

C4591001 Page 1of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT16.1.4.1 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 ): 45330
Total Number of Subjects Randomized/Entered (Per Study ):43888
ARGENTINA
Number of Sites (Per Country ): 1
Number of Subjects Screened (Per Country ): 5896
Number of Subjects Randomized/Entered (Per Country ): 5776
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 
PolackAdolfo Gonzalez 
Ossorio
Sebastian Grinstein
Marina Guglielmino
Maria Gutierrez 
Meyer
Leandro Heffner
Luciana Hernandez
Maria Herrera Jure
Maria Herrera 
Ledesma
Alejandra Hintze
Pablo Hurevich
Noelia Iraizos Zegarra
Nicolas Itcovici
Maria JelovinaHospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Luis María Campos 726 Piso 8
CABA, 1426
ARGENTINA5896 5776
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT)
Page 1
FDA-CBER-2021-5683-1072193
C4591001 Page 2of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Andres Kogan
Eduardo Landa
Fernando Lanzilotti
Lorena Larroude
Rom ina Libster
Juan Lopez
Juan Lopez
Rocio Lopez Castelo
Agustin Losinno
Natalia Lozano
Gabriela Lucero
Federico Luna
Julieta Maffia
Fernando Magdalena
Ezequiel Maldonado
Maria Malvicino
Janet del Valle 
Manrique Lopez
Natalia Mansilla 
Irusta
Valeria Manzanares
Carla Marchionatti
Leticia Marcos
Daniela Marino
Paola Martin
Claudia Martinez
Macarena Martinez 
Crespo
Ines Martinez Rom ero
Maria Martí
Gisela Maspero
Jose Meana Gonzalez
Soledad Mendoza
Cintia Morales
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 2
FDA-CBER-2021-5683-1072194
C4591001 Page 3of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Ileana Moreira 
Varanesse
Amalia Moschen
Natalia Mozeluk
Dalila Nafeh
Maria Name
Lucia Narvaez
Luis Neira
Maria Neira
Cinthia Nenninger
Sabrina Nowicky
Juan Nuñez
Jimena Ochoa
Sabrina Odriozola
Emilio Ominetti
Melisa Orrego
Lucila Orsomarso
Graciela Ortiz
Eliana Ortiz Tolaba
Maria Oyarvide
Salome Pagni
Maria Paladino
Florencia Palmieri
Mariana Palopoli
Maria Panighetti
Fernando Peralta 
Luna
Gonzalo Perez Marc
Rafael Perez Vidal
Carlos Pessolani
Maria Pirker Asategui
Maria Pitocco
Felipe Pomes
Florencia Quadrana
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 3
FDA-CBER-2021-5683-1072195
C4591001 Page 4of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Manuel Quiroz
Alejo Quiñones 
Maffassanti
Maria Rajuan
Maria Ramon
Paula Ramos
Mariel Rando
Micaela Re Furci
Patricia Rearte 
Carvalho
Valeria Regairaz
Rom ina Renner
Yanina Rivera
Micaela Rivero
Cecilia Robledo
Paula Robredo
Maria Ruffa
Maria Ruiz Cobos
Betiana Sabbattini
Sofia Salvia
Maria Sandoval
Ana Schindler
Laura Schiró
Lionel Schuster
Tamara Schvarstein
Georgina 
Sciancalepore
Agostina Sdrigotti
Barbara Soberon
Gonzalo Sola
Diego Staffieri
Lila Sueldo
Valeria Svartman 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 4
FDA-CBER-2021-5683-1072196
C4591001 Page 5of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Menezes
Daniela Szlaen
Mariana Thuns
Laura Tisser
Juan Torres Moirano
Diego Tourn
Virginia Trias Uriarte
Ignacio Uriarte
Anabel Vaca Lizzi
Rita Valdez
Emmanuel Valls
Mercedes Vazquez
Gabriela Vecchio
Juan Jose Vega
Maria Vera 
Morandini
Ana Liss Vergez
Javier Veron
Sebastian Vidaurreta
Alejandra de Lourdes 
Vigliano
Vanina Vilaseca
Florencia Virili
Juan Voievdca
Marino Volpe
Santiago Vommaro
Veronica Wahren
Diego Wappner
Diego Waserman
Giselle Wehit
Cristian Wood
Anastasiya Yashnyk
Rom ina Zadoff
Agustina Zavaleta
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 5
FDA-CBER-2021-5683-1072197
C4591001 Page 6of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Marisa Zocca
Joaquin Zunzuneguy
Nicolas de Pro
Isabel 
Abramovich(Previous 
SubI)
Maria 
Accorinti(Previous 
SubI)
Solange Acosta 
Altabe(Previous 
SubI)
Gaston Agudo 
Franco(Previous 
SubI)
Caterina Lisette 
Aguilar 
Rom an(Previous 
SubI)
Antonio 
Aguilera(Previous 
SubI)
Maria Florencia 
Aiccardi(Previous 
SubI)
Mariana 
Albarracin(Previous 
SubI)
Isabel Alvarez 
Burgos(Previous 
SubI)
Federico Alvarez 
Loray(Previous SubI)
Anabella Alvarez 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 6
FDA-CBER-2021-5683-1072198
C4591001 Page 7of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Mandias(Previous 
SubI)
Maria 
Andreau(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)
Cristian 
Avellino(Previous 
SubI)
Irina Aznaryn Leon 
Rom ero(Previous 
SubI)
Maria 
Baccini(Previous 
SubI)
Maria 
Bachella(Previous 
SubI)
Laura Baffa(Previous 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 7
FDA-CBER-2021-5683-1072199
C4591001 Page 8of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
SubI)
Lorena 
Bajinay(Previous 
SubI)
Magdalena 
Bajo(Previous SubI)
Sebastian 
Batagelj(Previous 
SubI)
Néstor Bautista 
Herrera(Previous 
SubI)
Gabriela 
Belachur(Previous 
SubI)
Sebastian 
Belchior(Previous 
SubI)
Antonella 
Berutti(Previous 
SubI)
Juan 
Bidegain(Previous 
SubI)
Ricardo 
Blanco(Previous 
SubI)
Maria Cecilia 
Bourgeois(Previous 
SubI)
Maria 
Breppe(Previou s 
SubI)
Benjamin 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 8
FDA-CBER-2021-5683-1072200
C4591001 Page 9of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Buteler(Previous 
SubI)
Alejandro 
Capdevilla(Previous 
SubI)
Maria Carballo 
Lencina(Previous 
SubI)
Federico 
Cardahi(Previous 
SubI)
Hugo 
Carranza(Previous 
SubI)
Barbara 
Carrizo(Previous 
SubI)
Gustavo 
Casado(Previous 
SubI)
Ana Maria 
Casalins(Previous 
SubI)
Andrea 
Castelo(Previous 
SubI)
Maria Castillo 
Areco(Previous SubI)
Cyntia 
Castro(Previous SubI)
Fabian Castro 
Barros(Previous 
SubI)
Francisco Castro 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 9
FDA-CBER-2021-5683-1072201
C4591001 Page 10of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Montiel(Previous 
SubI)
Marian 
Chacoff(Previous 
SubI)
Yolanda 
Chanampa(Prev ious 
SubI)
Analía 
Christmann(Previous 
SubI)
Sergio 
Cortez(Previous 
SubI)
Ignacio 
Croci(Previous SubI)
Maria 
Cuervo(Previous 
SubI)
Rafael 
Dalpra(Previous 
SubI)
Maria Dangelo 
Exeni(Previous SubI)
Barbara De 
Nardo(Previous SubI)
Dario Del 
Percio(Previous SubI )
Julia Delgado 
Riveros(Previous 
SubI)
Mariela 
Deraiopian(Previous 
SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 10
FDA-CBER-2021-5683-1072202
C4591001 Page 11of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Maria Diez(Previous 
SubI)
Maria Rey(Previous 
SubI)
Ana Riveros(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)
Maria 
Roque(Previous SubI)
Silvia Rossi(Previous 
SubI)
Guillermina Roveda 
Verges(Previous 
SubI)
Florencia 
Salani(Previous SubI)
Myriam 
Sanchez(Previous 
SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 11
FDA-CBER-2021-5683-1072203
C4591001 Page 12of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Martha Sanchez 
Navarro(Previous 
SubI)
Tatiana Sanchez 
Quiroga(Previous 
SubI)
Gaspar 
Sanfilippo(Previous 
SubI)
Ignacio 
Santarelli(Previous 
SubI)
Agustina 
Santoni(Previous 
SubI)
Francisco Santucho 
Saravia(Previous 
SubI)
Agustina del Rosario 
Sbruzzi(Previous
SubI)
Micaela 
Schiavi(Previous 
SubI)
Violeta 
Schneider(Previous 
SubI)
Fernando 
Sebastiani(Previous 
SubI)
Armando 
Segret(Previous SubI)
Virginia Seguel 
Jabat(Previous SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 12
FDA-CBER-2021-5683-1072204
C4591001 Page 13of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Franco 
Servat(Previous SubI)
Jose Shiraishi 
Ferreyra(Previous 
SubI)
Lucinardo Soares 
Belarmino(Previous 
SubI)
Martin Soria(Previous 
SubI)
Eleonora 
Sorin(Previous SubI)
Barbara 
Sparrow (Previous 
SubI)
Giuliana 
Sposito(Previous 
SubI)
Patricia 
Stach(Previous SubI)
Esteban 
Suarez(Previous 
SubI)
Analia Suarez 
Pulido(Previous Sub I)
Martin 
Taboada(Previous 
SubI)
Raul 
Taboada(Previous 
SubI)
Natali Tanel(Previous 
SubI)
Maria Tarrazo 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 13
FDA-CBER-2021-5683-1072205
C4591001 Page 14of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Barranco(Previous 
SubI)
Luciana 
Terracina(Previous 
SubI)
Sebastian 
Tisman(Previous 
SubI)
Elda Tralice(Previous 
SubI)
Nancy 
Urquiza(Previous 
SubI)
Paula V aldez 
Tappata(Previous 
SubI)
Antonela 
Valente(Previous 
SubI)
Leandro Vallejos 
Insegna(Previous 
SubI)
Federico 
Vecchietti(Previous 
SubI)
Victoria 
Verga(Previous SubI)
Patricia Vides De la 
Hoz(Previous SubI)
Florencia 
Villegas(Previous 
SubI)
Dayler Virgo 
Zambrana(Previous 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 14
FDA-CBER-2021-5683-1072206
C4591001 Page 15of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
SubI)
Virginia 
Visco(Previous SubI)
Melisa 
Dollanart(Previous 
SubI)
Lourdes Dominguez 
Figueredo(Previous 
SubI)
Belen 
Duarte(Previous 
SubI)
Andrea del Socorro 
Duque 
Ramirez(Previous 
SubI)
Francisco 
Dusio(Previous SubI)
Pablo 
Echeverria(Previous 
SubI)
Maria 
Espinosa(Previous 
SubI)
Samanta 
Estevez(Previous 
SubI)
Florencia 
Feldman(Previous 
SubI)
Martina 
Fernandez(Previous 
SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 15
FDA-CBER-2021-5683-1072207
C4591001 Page 16of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Nicolas 
Ferrari(Previous 
SubI)
Karen de Fatima 
Figueroa 
Bohorquez(Previous 
SubI)
Maria Fulco(Previous 
SubI)
Belkys 
Garcia(Previous 
SubI)
Emiliano Garcia 
Coloccini(Previous 
SubI)
Ezequiel 
Gayer(Previous SubI)
Maria 
Ghiberti(Previous 
SubI)
Maria 
Gimenez(Previous 
SubI)
Virginia 
Godoy(Previous 
SubI)
Barbara 
Gom ez(Previous 
SubI)
Adriana Gon calves de 
Almeida(Previous 
SubI)
Jose Luis 
Gonzalez(Previous 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 16
FDA-CBER-2021-5683-1072208
C4591001 Page 17of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
SubI)
Liliana 
Gonzalez(Previous 
SubI)
Maria 
Gonzalez(Previous 
SubI)
Ezequiel 
Graziano(Previous 
SubI)
Julia 
Grigioni(Previous 
SubI)
Jhonatan Guerrero 
Gallego(Previous 
SubI)
Johana 
Gutierrez(Previo us 
SubI)
Ruth 
Henquin(Previous 
SubI)
Milagros 
Heredia(Previous 
SubI)
Ramiro 
Heredia(Previous 
SubI)
Rocío 
Heredia(Previous 
SubI)
Macarena 
Ilarregui(Previous 
SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 17
FDA-CBER-2021-5683-1072209
C4591001 Page 18of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Maria 
Irigoyen(Previous 
SubI)
Hernán 
Jamui(Previous SubI)
Ximena 
Juarez(Previous SubI)
Veronic a Junyent 
Berrotaran(Previous 
SubI)
Valeria Kes(Previous 
SubI)
Paola 
Koslowski(Previous 
SubI)
Jose Labella(Previous 
SubI)
Fernando 
Landreau(Previous 
SubI)
Carolina 
Laurence(Previous 
SubI)
Martina 
Leonard(Previous 
SubI)
Juan Martin Lourenco 
da Cunha(Previou s 
SubI)
Flavia Luna 
Matheu(Previous 
SubI)
Clarice Madureira 
Cena(Previous SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 18
FDA-CBER-2021-5683-1072210
C4591001 Page 19of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Carolina 
Magadan(Previous 
SubI)
Miguel Magallanes 
Quijandria(Previous 
SubI)
Natalia 
Mammana(Previous 
SubI)
Ana 
Mansilla(Previous 
SubI)
Felix 
Marasco(Previous 
SubI)
Betiana 
Martin(Previous 
SubI)
Maximiliano 
Martinez(Previous 
SubI)
Maria 
Martino(Previous 
SubI)
Maria 
Marugo(Previous 
SubI)
Ines 
Mattausch(Previous 
SubI)
Anabella 
Mazzeo(Previous 
SubI)
Maria Florencia 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 19
FDA-CBER-2021-5683-1072211
C4591001 Page 20of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Mazzeo(Previous 
SubI)
Tom as 
Meglia(Previous 
SubI)
Maria 
Melito(Previous 
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)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 20
FDA-CBER-2021-5683-1072212
C4591001 Page 21of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Rocio 
Navarro(Previous 
SubI)
Pablo 
Naveira(Previous 
SubI)
Marco Antonio 
Nogara(Previous 
SubI)
Gabriela 
Norese(Previous 
SubI)
Gabriela 
Novoa(Previous 
SubI)
Natalia 
Nuñez(Previous SubI)
Gaston 
Ofman(Previous 
SubI)
Maria Pia Olivera 
Abdala(Previous 
SubI)
Agustina 
Ordoñez(Previous 
SubI)
Marco 
Ottino(Previous SubI)
Mariela del Carmen 
Panichella(Previous 
SubI)
Maria Pattin(Previous 
SubI)
Anabella 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 21
FDA-CBER-2021-5683-1072213
C4591001 Page 22of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Pecheny(Previous 
SubI)
Constanza 
Peire(Previous SubI)
Maria Clara 
Perez(Previous SubI)
Maria Perez 
Latessa(Previous 
SubI)
Andres 
Petrocelli(Previous 
SubI)
Diana 
Pieniazek(Previous 
SubI)
Sebastian 
Pogliani(Previous 
SubI)
Silvina 
Polacov(Previous 
SubI)
Evangelina 
Pujadas(Previous 
SubI)
Valeria Quinteros 
Caceres(P revious 
SubI)
Noelia 
Quispe(Previous 
SubI)
Valeria 
Quispe(Previous 
SubI)
Agustin Quiñones 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 22
FDA-CBER-2021-5683-1072214
C4591001 Page 23of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Maffassanti(Previous 
SubI)
Pablo 
Ramondelli(Previous 
SubI)
Cecilia Ray(Previous 
SubI)
Luciana 
Real(Previous SubI)
Carlos 
Reguera(Previous 
SubI)
Debora 
Reichbach(Previous 
SubI)
Maria 
Retrivi(Previous 
SubI)
Paula Agosti
Omar Aguayo
Carla Airoldi
Maria Airoldi
Mariano Aizpurua
Graciela Alegre
Julieta Alfonso
Maria Allende
Julieta Arredondo 
Martinez
Victoria Auzmendi
Maria Avena
Maria Azpiroz
Luis Balaguer
Lucrecia Bandeo
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 23
FDA-CBER-2021-5683-1072215
C4591001 Page 24of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Alan Barrego
Mirta Becerra Pons
Cynthia Belo
María Bengoa
Maria Beretta
Federico Bianco
Favio Bigas
Felipe Bilbao
Jessica Bilstein
Maria Blanco
Lucia Bonfada
Maria Borio
Sergio Buscazzo
Guillermo Calderon
Belen Camardelli
Mari a Camean
Jorgelina Candia
Angela Carbajal 
Maldonado
Federico Cardozo
Josefina Carrano
Lorena Casal
Analia Castellano
Viviana Elizabeth 
Cavenago
Maria Cedron
Solana Ceretti
Agustina Chidichimo
Manuel Clavijo
Ivana Cobos
Paola Codianni
Florencia Cogo 
Orellana
Luciana Compostela
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 24
FDA-CBER-2021-5683-1072216
C4591001 Page 25of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Milena Corengia
Santiago Corradetti
Sofia Costa
Gabriel Cracovski
Mariano Crespo
Evangelina Cueto
Jesica Cufre
Valeria Cugnu
Dolores Curubeto
Maria D`Ascoli Onel
Martin Darraidou
Florencia De Lafore
Valeria De Las saletta
Jimena Del Rincon
Micaela Delgado
Patricia Devesa
Victoria Di Nardo
Lucila Di Nunzio
Alejandro Diaz
Ana Donnari
Ana Belen Duarte
Sabrina Dulce
Mariana Dunaiewsky
Ignacio Esteban
Sara Esteche Roman
Natali Estrada
Tatiana Estrada
Maria Etchegaray
Vanesa Fainboim
Nicolas Falk
Emanuel Fedun 
Rodriguez
Jose Fernandez 
Abuye
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 25
FDA-CBER-2021-5683-1072217
C4591001 Page 26of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Lucia Fernandez 
Abuye
Valentina Fernandez 
Alberdi
Paula Fernández 
Estrella
Juan Ferraris
Andres Ferreyra
Santiago Foti
Jimena Franco
Paula Franco
Hernan Freire
Jorge Fuentes
Agustina Furnari
Maria Victoria 
Eugenia Gaete Orueta
Agustin Galarza
Juan Galeano
Mariano Garabito
Victoria Garcia
Natalia Garcia Escude
Tom as Garcia 
Solchaga
Julieta Gelardi
Sergio Gelman
Eduardo Gimenez
Laura Giovanetti
Facundo Gonzalez
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 26
FDA-CBER-2021-5683-1072218
C4591001 Page 27of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        BRAZIL
Number of Sites (Per Country ): 2
Number of Subjects Screened (Per Country ): 2927
Number of Subjects Randomized/Entered (Per Country ): 2900
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 Eliane 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
BRAZIL1359 1351
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, 161
Salvador, BA 40415 -006
BRAZIL1568 1549
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 27
FDA-CBER-2021-5683-1072219
C4591001 Page 28of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Santos
João Soares Costa
Rafael Solla Galvão
Yuri Boa Sorte de 
Oliveira
Dom inique da Silva
Antonio Matos de 
Figueiredo 
Filho(Previous SubI)
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 28
FDA-CBER-2021-5683-1072220
C4591001 Page 29of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        GERMANY
Number of Sites (Per Country ): 6
Numbe r of Subjects Screened (Per Country ): 514
Number of Subjects Randomized/Entered (Per Country ): 500
Coordinating Investigator: 
<None Entered>
Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
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 66
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 104
1195 Axel Schaefer Mazin Sanuri Medizentrum Essen Borbeck
Huelsmannstrasse 6
Essen, 45355
GERMANY158 158
1197 Matthias 
LuttermannLars Pohlmeier
Torsten DrescherStudienzentrum 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
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 29
FDA-CBER-2021-5683-1072221
C4591001 Page 30of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
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 60
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 30
FDA-CBER-2021-5683-1072222
C4591001 Page 31of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        SOUTH AFRICA
Number of Sites (Per Country ): 4
Number of Subjects Screened (Per Country ): 842
Number of Subjects Randomized/Entered (Per Country ): 800
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 210
1230 Leon Fouche Michiel Buys
Muhammed Fulat
Thinti Moreroa
Danellus Van Der 
watt
Pieter -Louis 
VollgraaffLimpopo Clinical Research Initiative
Tamboti Medical Centre
11 Van der Bijl Street
Thabazimbi, LIMPOPO 0380
SOUTH AFRICA224 210
1246 Dany 
MusungaieCharlotte De Jong
Douwe de JongJongaie Research
Medicross Pretoria West, 1st Floor, 551 WF Nkomo Street
Pretoria, GAUTENG 0183
SOUTH AFRICA141 130
1247 Haylene Nell Zarinah Mohamed
Mirna Siebert
Matthys Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
c/o Mike Pienaar Boulevard & Frans Conradie Avenue, Bellville
Cape Town, WESTERN CAPE 7530260 250
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 31
FDA-CBER-2021-5683-1072223
C4591001 Page 32of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Basson(Previous 
SubI)
Precious 
Garnett(Previous 
SubI)
Rehana 
Loghdey(Previous 
SubI)
Catharina 
Pretorius(Previous 
SubI)
Maria 
Pretorius(Previous 
SubI)SOUTH AFRICA
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 32
FDA-CBER-2021-5683-1072224
C4591001 Page 33of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        TURKEY
Number of Sites (Per Country ): 9
Number of Subjects Screened (Per Country ): 500
Number of Subjects Randomized/Entered (Per Country ): 500
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 80
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 69
1208 Iftihar Koksal Yildiz Okuturlar
Alpay YesilaltayAcibadem Atakent Hastanesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Birimi
Kucukcekmece
Istanbul, 34303
TURKEY55 55
1209 Sedat Altin Gulsah Gunluoglu
Dery a Hircin Cenger
Kerem TurkmenIstanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim 
Arastirma Hastanesi
Zeytinburnu
Istanbul, 34020
TURKEY21 21
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 33
FDA-CBER-2021-5683-1072225
C4591001 Page 34of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        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 36
1213 Omer Tabak Hazal Erdem
Bilgul MeteIstanbul Universitesi -Cerrahpasa, Cerrahpasa Tip Fakultesi
Enfeks iyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Fatih
Istanbul, 34098
TURKEY60 60
1214 Serap 
Simsek -YavuzCagla Keskin Saritas Istanbul Universitesi Istanbul Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Fatih
Istanbul, 34093
TURKEY55 55
1217 Sila Akhan Sonay Arslan Kocaeli Universitesi Tip Fakultesi
Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Anabilim Dali
Umuttepe
Kocaeli, 41380
TURKEY62 62
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 34
FDA-CBER-2021-5683-1072226
C4591001 Page 35of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        UNITED STATES
Number of Sites (Per Country ): 131
Number of Subjects Screened (Per Country ): 34651
Number of Subjects Randomized/Entered (Per Country ): 33412
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
Ramin Herati
Angelica Kottkamp
Alexander 
McMeeking
Mary  Olson
Lalitha Parameswaran
Purvi Parikh
Rebecca Pellett 
Madan
Kiana Piedrahita
Vanessa Raabe
Bo Shopsin
Janine Sullivan
Robert Ulrich
Andrew  
Fleming(Previous 
SubI)
Mila 
Ortigoza(Previous 
SubI)
Adam 
Ratner(Previous NYU Langone Health
Schwartz Health Care Center
530 First Ave, 12th Fl
New  York, NEW YORK 10016
UNITED STATES149 115
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 35
FDA-CBER-2021-5683-1072227
C4591001 Page 36of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
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 57
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 STATES210 170
1005 Matthew Davis Jenna Baer
Chelsea Bork
Michelle Burgett
Cristina Cramer -Mills
Kara Cristales
Kathleen Ebeling
Victoria Fink
Jennifer Foley
Geesue Hah
Deborah Hodges
Sarah Ingalsbe -Geno
Diana Kailburn
Mackay Kanaley
Patricia Larrabee
Joseph Mann
Abigail Miller
Julie Mooney
Katherine Rochester Clinical Research, Inc.
500 Helendale Rd, L20
Rochester, NY 14609
UNITED STATES399 389
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 36
FDA-CBER-2021-5683-1072228
C4591001 Page 37of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Pagenkemper
Jennifer Rowlinson
Tammi Shlotzhauer
Jaclyn Zona
Therese 
Dayton(Previous 
SubI)
Julie 
Wentw orth(Previous 
SubI)
Susan 
Willer(Previous SubI)
Zerina 
Zornic(Previous 
SubI)
1006 James Peterson Natalie Bee
Alexander Clark
Shana Eborn
Susan Edwards
Dan Henry
Heather Jackson
Gerald Kelty
Issac Pena -Renteria
Jacqueline Rohrer
Jack TaylorJ. Lew is Research, Inc. / Foothill Family Clinic
2295 Foothill Dr
Salt Lake City, UT 84109
UNITED STATES178 168
1007 Robert Frenck David Bernstein
Rebecca Brady
Kristen Buschle
Michelle Dickey
Grant Paulsen
Felicia Scaggs HuangCincinnati Children's Hospital Medical Center
Cincinnati Center for Clinical Research (CCCR)
619 Oak St
Cincinnati, OH 45206
UNITED STATES459 412
Cincinnati Children's Hospital Medical Center
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 37
FDA-CBER-2021-5683-1072229
C4591001 Page 38of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Paul Spearman
Eleanor WiddiceGam ble Program for Clinical Studies
3333 Burnet Ave, MLC 6014
Cincinnati, OH 45229 -3039
UNITED STATES
Cincinnati Children's Hospital Medical Center
Oak Investigational Pharmacy
619 Oak St, 2nd Fl, Rm 2411
Cincinnati, OHIO 45206
UNITED STATES
1008 Timothy 
JenningsSiddharth Kaul
Anthony Margherita
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 STATES746 745
1009 Shane 
ChristensenHolly Anderson
Emily Bloomquist
Ross Brunetti
Thomas Conner
Gina Cox
Diana Grazulis
Wesley Lewis
James Longe
Christopher Matich
Bryan Nelson
Emily Raming
Sarah Scott
John WitbeckJ. Lew is Research, Inc. / Foothill Family Clinic South
6360 S 3000 E, Ste 100
Salt Lake City, UT 84121
UNITED STATES261 252
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 38
FDA-CBER-2021-5683-1072230
C4591001 Page 39of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
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 227
1012 Matthew Doust Nathan Alderson
Stephanie Catanzaro
Sandra Erickson
Shauna Harrell
Shana Harshell
Denise Sample
Dhwani Shah
Steven Siwek
Sahara Vega
Jennifer 
Burgdorf(Previous 
SubI)HOPE Research Institute
3900 E. Camelback Rd, Ste 125, 130 & 135
Phoenix, AZ 85018
UNITED STATES188 184
The Pain Center of Arizona
3900 E. Camelback Rd, Ste 190
Phoenix, AZ 85018
UNITED STATES
1013 Michael Dever Patricia Brow n
Letitia Griffin
Linda Harper
Rebecca Klipper
Geraldine Marino
Robert Molpus
Priya Moorhouse
Penny O'Neal
Deborah Renner
Felipe SuplicyClinical Neuroscience Solutions, Inc
618 E. S St, Ste 100
Orlando, FL 32801
UNITED STATES814 795
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 39
FDA-CBER-2021-5683-1072231
C4591001 Page 40of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Joan Cutillo(Previous 
SubI)
1015 Elizabeth 
BarnettSacha Al Hassan
Deepa Anbumani
Kanika Bisht
Tori Blot
Ellen Cooper
Ycar Devis
Faye Huang
Dayeun Lee
Debra McLaud
Carole Moloney
Casey Norton
Stephen Pelton
Vishakha Sabharwal
Scarlett Salerno
Javier Sanchez
Ridiane 
Denis(Previous SubI)
Yuri Kim(Previous 
SubI)
Mona 
Lauture(Previous 
SubI)
Mary  Walsh(Previous 
SubI)Boston Medical Center
1 Boston Medical Center Pl., Shapiro Bldg. 9th Fl.
Boston, MA 02118
UNITED STATES266 264
1016 Daniel Finn Ashley Bennett
Lindsay Blackmon
Stanley Block
Christal Denton
Lisa Dones
Whitney DownsKentucky Pediatric/ Adult Research
201 S 5th St
Bardstown, KENTUCKY 40004
UNITED STATES347 336
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 40
FDA-CBER-2021-5683-1072232
C4591001 Page 41of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
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
1018 Veronica 
FragosoTeresa Becker
Blanca Gomez
Lisa Hollow ay
Odette Kourouma
Tracy Kow alski
Cecilia 
McKeown -Biagas
Vicki MillerTexas Center for Drug Development, Inc.
6550 Mapleridge St, Ste 201, 206, 220
Houston, TEXAS 77081
UNITED STATES351 326
1019 Charles 
AndrewsJohn Holcomb Diagnostics Research Group
4410 Medical Dr, Ste 360
San Antonio, TEXAS 78229
UNITED STATES323 315
1021 John Rubino Warner Edmundson
Tina Harris
William Jacobs
Douglas ShortPMG Research of Raleigh, LLC
3521 Haw orth Dr, Ste 100
Raleigh, NC 27609252 252
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 41
FDA-CBER-2021-5683-1072233
C4591001 Page 42of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Adeel Siddiqui
Stephanie Stoneback
Sarah UtechUNITED STATES
1022 Steven Kaster Diane Davis
Kathryn Eren
Linda Galvan
Patricia Garland
Jason Lake
Cathy Jo Roozen
Lauryn Wilson
Rebecca Woolston
Eliza 
Zuniga(Previous 
SubI)Wenatchee Valley Hospital
Clinical Research Department
820 N Chelan Ave
Wenatchee, WA 98801
UNITED STATES177 170
1024 Christopher 
LucastiDawn Paone South Jersey Infectious Disease
730 Shore Rd
Somers Point, NJ 08244
UNITED STATES132 128
1027 Alexander 
MurrayLeanna Cutchins
William Harris
Susanne Stuckey
Randal Von Seggern
Richard 
Tisovec(Previous 
SubI)Pharm Quest
806 Green Valley Rd, Ste 305
Greensboro, NC 27408
UNITED STATES216 215
1028 Michael 
LillestolJamie Brown
Karissa EmersonLillestol Research LLC
4450 31st Ave S, Ste 101
Fargo, ND 58104
UNITED STATES296 289
1030 Robert Salata Scott Fulton University Hospitals Cleveland Medical Center 158 156
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 42
FDA-CBER-2021-5683-1072234
C4591001 Page 43of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Elie Saade
George Yendewa11100 Euclid Ave
Cleveland, OH 44106
UNITED STATES
1036 Marcus Lee Robert Nichols
Diane SmithTrinity Clinical Research
709 NW Atlantic St
Tullahoma, TN 37388
UNITED STATES145 141
1037 Lisa Usdan 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 349
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
Ana Paez
Bandana Risal
Amy SiegelARC Clinical Research at Wilson Parke
11714 Wilson Parke Ave., Ste 150
Austin, TX 78726
UNITED STATES240 224
1042 William Seger Oluwatosin 
AkingbalaBenchmark Research
4504 Boat Club Rd, Ste #400A269 245
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 43
FDA-CBER-2021-5683-1072235
C4591001 Page 44of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Mohammed Antwi
Elizabeth Boydston
Tisha Davis
Deborah Devlin
Melody Dufrene
Allison Green
Alma Guel
Anthony Kim
Samantha Loudermilk
Virginia Loudermilk
Alena Mitchell
Kimberly Pullen
Abdur Qadri
Ben Seger
Maria Seger
Jean Seignon
John VillegasFort Worth, TX 76135
UNITED STATES
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 23114
UNITED STATES230 226
1046 Ernest Hendrix Maria Acelajado 
Onoya
Matthew Caldwell
Matthew HanserdNorth Alabama Research Center, LLC
721 W Market St, Ste B
Athens, AL 35611
UNITED STATES340 337
1047 James 
McMurrayMichael Carter
Timothy Howard
Tiffany LozovskyMedical Affiliated Research Center
303 Williams Ave, Ste 511
Huntsville, AL 35801
UNITED STATES332 327
1048 Abram Burgher Nathan Alderson HOPE Research Institute 133 131
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 44
FDA-CBER-2021-5683-1072236
C4591001 Page 45of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
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)2525 W. Greenw ay Rd, Ste 220
Phoenix, AZ 85023
UNITED STATES
HOPE Research Institute
2525 W. Greenw ay Rd, Ste 250
Phoenix, AZ 85023
UNITED STATES
1052 Suzanne Fussell Cynthia Chao
Jessica Fox
Viviana Gonzalez
Joseph Iw uajoku
Samir Mehta
Tamira WadeLong Beach Clinical Trials Services Inc.
2403 Atlantic Ave
Long Beach, CA 90806
UNITED STATES178 175
1054 Mark Leibowitz Rea Cruz Abaniel
Juan Frias
Robert Jenders
John Nelson
Parvin SyalNational Research Institute
2010 Wilshire Blvd., Ste 302 and 809
Los Angeles, CA 90057
UNITED STATES214 204
1055 Helen Stacey Mark Christiansen
Leonard Chuck
Catherine Morimoto
Lana Norman
Meaghan SaintDiablo Clinical Research, Inc.
2255 Ygnacio Valley Rd, Ste M
Walnut Creek, CA 94598
UNITED STATES247 246
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 45
FDA-CBER-2021-5683-1072237
C4591001 Page 46of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
1056 Jose Cardona Victoria Roque
Evelio SosaIndago Research & Health Center, Inc.
3700 W 12th Ave, Ste 300
Hialeah, FL 33012
UNITED STATES643 611
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 STATES362 357
1066 David Butuk Janelle Barney
Janaie Bounsana
Erin Brennan
Melissa Conrad
Scott Frisby
Meredith 
Mangum(Previous 
SubI)
Paige 
McKenzie(Previous 
SubI)
Kaylee 
Ruckrigl(Previous 
SubI)Solaris Clinical Research
1525 E Leigh Field Dr, # 100
Meridian, ID 83646
UNITED STATES390 387
1068 Andrew  Gentry Christopher Lumsden
Melissa Pew
Rebecca Rassi
Mark Winton
David King(Previous 
SubI)Bozeman Health Deaconess Hospital dba Bozeman Health Clinical 
Research
915 Highland Blvd
Bozeman, MT 59715
UNITED STATES118 117
Bozeman Health Deaconess Hospital dba Bozeman Health Clinical 
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 46
FDA-CBER-2021-5683-1072238
C4591001 Page 47of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Research
931 Highland Blvd., Ste 3103
Bozeman, MONTANA 59715
UNITED STATES
1071 Michael Dunn Ronald Anderson
John Hallgren
Brian Hollis
Rudolf KotulaQuality Clinical Research, Inc.
10040 Regency Cr, Ste 375
Omaha, NEBRASKA 68114
UNITED STATES249 237
1072 Randle 
MiddletonBrittanie Alexander
Courtney Carter
Misty Dixon
Charlotte Edmondson
Holly Gipson
Nafisa Neighbors
Lauren Stiles
Joyce Todd
Terina Weir
Reba LuAnne 
Boggs(Previous SubI)
Heather 
Mahoney(Previous 
SubI)Optimal Research, LLC
2089 Cecil Ashburn Dr, Ste 203
Huntsville, AL 35802
UNITED STATES101 101
1073 Corey Anderson Lisa Dean
Naom i Devine
Georgina 
Lopez- Wood
Tasha Marriott
James Ramsey
Victor 
Salazar -Calderon
Cecilia TanoriAlliance for Multispecialty Research, LLC
2737 W. Baseline Rd., Ste 19
Tempe, AZ 85283
UNITED STATES130 124
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 47
FDA-CBER-2021-5683-1072239
C4591001 Page 48of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Nathan Tauta
1077 Suchet Patel 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 STATES270 261
Meridian Clinical Research LLC
409 Hooper Rd
Endw ell, NEW YORK 13760
UNITED STATES
1079 George Raad Kam eron Dugat
John Sensenbrenner
Zachary 
Larmore(Previous 
SubI)
Edward 
Mogabgab(Previous 
SubI)PMG Research of Charlotte LLC
1700 Abbey Place, Ste 201
Charlotte, NC 28209
UNITED STATES316 309
1080 Sylvia Shoffner Scott Bilbro
Susan Crittenden
Garett Franklin
Samantha Kiker
Sujatha Raman
Amanda Reed
Derek Schroder
Nicole 
Ando(Previous SubI)
Savannah 
Shultz(Previous SubI)
Maurice PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
530 New  Waverly Place, Ste 200A
Cary, NC 27518
UNITED STATES223 217
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 48
FDA-CBER-2021-5683-1072240
C4591001 Page 49of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Smith(Previous SubI)
1081 Michael Butcher Diane Broadnax
James Fry
Gayle Hennekes
Marcel Lanton
Donna Percy
Rachel 
Crabtree(Previous 
SubI)
Karen 
Freudemann(Previous 
SubI)Sterling Research Group, Ltd.
2230 Auburn Ave, Level B
Cincinnati, OH 45219
UNITED STATES212 210
1082 William Smith Katherine Buckner
Richard Gibson
Talya ThomasAlliance for Multispecialty Research, LLC
1924 Alcoa Hwy, 4 and 5 Nw
Knoxville, TENNESSEE 37920
UNITED STATES224 214
1083 Laurence Chu Jennifer Bacchi
Maria Barrientes
Lamar Box
Christian Casas
Ruth Michelle 
Chouteau
Lauren Christal
Pamela Conley
Katherine Davis
Tambra Dora
Cindy Duran
Pamela Fidler
Ruth Fitch
Brooke Harris
Isaiah KnightBenchmark Research
3100 Red River St, Ste 1
Austin, TX 78705
UNITED STATES280 254
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 49
FDA-CBER-2021-5683-1072241
C4591001 Page 50of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Jennifer Leyva
Michelle Listz
Jennifer Montes
Javier Perez
Jessica Ruff
Dean Skiles
Sean Turnbow
Francesca Vigil
Breana Wade
Kelly Weber
Taylor 
Bartlett(Previous 
SubI)
Selena 
Bermudez(Previous 
SubI)
Clara Loza(Previous 
SubI)
1084 Douglas 
DenhamMaristelle Co
Parke Hedges
Mary  Jo 
Perez -Jenkins
Cynthia Ramos
Thomas Weiss
Darlington 
Akahara(Previous 
SubI)
Ayoade 
Avworo(Previous 
SubI)Clinical Trials of Texas, Inc.
5430 Fredericksburg Rd, Ste 200
San Antonio, TEXAS 78229
UNITED STATES539 523
Clinical Trials of Texas, Inc.
5430 Fredericksburg Rd., Ste 601
San Antonio, TEXAS 78229
UNITED STATES
1085 Gregory Fuller Pamela Martin Ventavia Research Group, LLC
300 N Rufe Snow  Dr375 369
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 50
FDA-CBER-2021-5683-1072242
C4591001 Page 51of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Tracy Starnes Keller, TX 76248
UNITED STATES
1087 Kevin Cannon Mesha Chadwick PMG Research of Wilmington, LLC
1907 Tradd Court
Wilm ington, NC 28401
UNITED STATES601 594
1088 John Earl Robert Hart
Jennifer Lail
Scott Polster
Maranda Rhudy
Heather Warta
Heather 
Barnett(Previous 
SubI)
Nicole 
Everhart(Previous 
SubI)
Ryan Parker(Previous 
SubI)
Shai Perry(Previous 
SubI)
Kristen 
Sherrill(Previous 
SubI)PMG Research of Hickory, LLC
221 13th Ave Pl NW, Ste 201
Hickory, NC 28601
UNITED STATES261 260
1089 Cecil Farrington Laura Kruchkow
Cortney Ledbetter
Kishan Maramraj
Robert McNeill
Jamie Myers
Kim PottsPMG Research of Salisbury, LLC
410 Mocksville Ave
Salisbury, NC 28144
UNITED STATES353 349
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 51
FDA-CBER-2021-5683-1072243
C4591001 Page 52of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
1090 Wayne Harper Lori Bridges
Lisa Cohen
Lynn Eckert
Matthew Hong
Kendra Lisec
Adnan Nasir
Amanda Olsen
James 
Earnhardt(Previous 
SubI)
Douglas 
Wadeson(Previous 
SubI)M3 Wake Research, Inc.
3100 Duraleigh Rd, Ste 304
Raleigh, NC 27612
UNITED STATES564 533
1091 Samir Arora Rafe Bari
Brittany Biro
Brennan Brothers
Grazia Cannon
Jess DeMaria
Sophia Gaines
Sridhar Guduri
Jessica Harpel
Chelsea Hughes
Layne Mikanik
Lindsay Newton
Jessica Spear
Roy St. JohnAventiv Research Inc.
99 N. Brice Rd, Ste 210
Columbus, OHIO 43213
UNITED STATES386 374
Aventiv Research Inc.
99 N. Brice Rd, Ste 260
Columbus, OH 43213
UNITED STATES
1092 Rajesh Davit James Fry
Bruce Gebhardt
Gayle Hennekes
Victoria Hughes
Joanne Major
Padm a ManguSterling Research Group, Ltd.
375 Glensprings Dr, 2nd Fl
Cincinnati, OH 45246
UNITED STATES277 273
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 52
FDA-CBER-2021-5683-1072244
C4591001 Page 53of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Debra Schroeck
Cynthia Wright
1093 David Ensz Taylor Bergh
Tavane Harrison
Allie Oplinger
Meagan 
Miller(Previous SubI)Meridian Clinical Research
330 Dakota Dunes Blvd., (DAK), Ste 400
Dakota Dunes, SOUTH DAKOTA 57049
UNITED STATES227 202
1094 Murtaza 
MussajiMohammad Siddiqui LinQ Research, LLC
11021 Shadow  Creek Pkwy, Ste 102
Pearland, TEXAS 77584
UNITED STATES190 185
1095 Paul Pickrell Brandi Chalman
Eileen Euperio
Carol Linebarger
John Luna
Hussain Malbari
Stefanie Mott
Eugene Pampe
Melissa Winn
Paige 
Kenny(Previous 
SubI)Tekton Research, Inc.
4534 W Gate Blvd., Ste 110
Austin, TEXAS 78745
UNITED STATES307 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 STATES391 378
Hany H. Ahmed, MD
1919 N Loop W, 140
Houston, TX 77008
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 53
FDA-CBER-2021-5683-1072245
C4591001 Page 54of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
UNITED STATES
Ventavia Research Group, LLC
1919 N Loop W, Ste 250
Houston, TX 77008
UNITED STATES
1097 Tom  
ChristensenStephen Grubb
Steven Price(Previous 
SubI)Main Street Physician's Care
3600 Sea Mountain Hwy, Ste C
Little River, SOUTH CAROLINA 29566
UNITED STATES123 121
1098 Salma Saiger Amy Dunn
Kiery McMullen
Moiz ShafiqSMS Clinical Research, LLC
1210 N Gallow ay Ave
Mesquite, TX 75149
UNITED STATES263 258
1101 Thomas Wolf Colleen Caliri
Heather Diederich
John Dobleman
David Garcia
Renee Hochstein
Stacie Jarzynka
Bridget Ladwig
Shirley McLaurine
Christine Scheuring
Brandi Schulz
Andrea VerMaas
Jenny Belitz(Previous 
SubI)
Jessica 
Francis(Previous 
SubI)
Lynnda Methodist Physicians Clinic / CCT Research
350 W 23rd St
Frem ont, NE 68025
UNITED STATES120 116
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 54
FDA-CBER-2021-5683-1072246
C4591001 Page 55of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Schiermann(Previous 
SubI)
1107 Harry Studdard Carrie Allenbach
Dana Bekurs
Katelyn Howard
Michael Ledet
Pamela Manley
Anna MayAlliance for Multispecialty Research, LLC
100 Memorial Hospital Dr, Annex Bldg, Ste -3B
Mobile, AL 36608
UNITED STATES219 200
1109 Bruce Rankin Fadhel Alyunis
Vienna Bauer
Christian 
Beierschmitt
Tasha Brocato
Daniel Campbell
Jennifer Cline
Claxton Copeland
Jeanette De Leon
Craig Dean
Jennifer Dittman
Szheckera Fearon
Shatonia Fields
Jessica Gilliam
Angela Hammerle
Eva-Maria Heurich
John Hill
Ryan Hobbick
Melissa Hodges
Raine Hutchins
Christina Isbell
Taylor Martin
Clark Mason
Iman MenciaDeLand Clinical Research Unit
860 Peachw ood Dr
DeLand, FLORIDA 32720
UNITED STATES559 555
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 55
FDA-CBER-2021-5683-1072247
C4591001 Page 56of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Dhaneshwar Oomrow
Crystal Paccione
Antonio Rivera
Over Seijas
Steven Shinn
Thais Truffa
Michelle Tutt
Amber Vasquez
Erika Wierzbicki
1110 Jeffrey Rosen Eric Gancedo
Monica Mauri
Jennifer Mokross
Jenny Montes De Oca 
Pineda
Tamara Richards
Adam RosenAlliance for Multispecialty Research, LLC -Coral Gable
370 Minorca Ave, 2nd Fl
Coral Gables, FLORIDA 33134
UNITED STATES379 373
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 205
1112 Nathan Segall Michelle Binns
Kimberly Cobb
Mustafa Elhallaoui
Jon Finley
Jeffrey Jones
Susan Jones
Jennifer LeBrun
Nancy Levine
William Osborne
Michelle SowellClinical Research Atlanta
1215 Eagles Landing Pkwy, Ste 210/211
Stockbridge, GEORGIA 30281
UNITED STATES350 342
Clinical Research Atlanta
175 Country Club Dr, Bldg 100, Ste A
Stockbridge, GA 30281
UNITED STATES
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 56
FDA-CBER-2021-5683-1072248
C4591001 Page 57of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Cynthia Steele
Mildred Stull
Pamela Talbott
Donna Toepfer
Kwannda Whatley
Karen Yangapatty
Tyra Gaines(Previous 
SubI)
1114 Richard Glover Janelle Brown
Melissa Burton
Jordan Danby
Sheri Duncan
Amber Grant
Roby n Hartvickson
Lisa Hemmelgarn
Troy Holdeman
Jeri King
Riley King
Shannen Lassiter
Cayla Lawless
Marissa Mueller
Aaron Nguyen
Justin Phillips
Katherine 
Saengerhausen
Stacy Slechta
Shannon Thomas
Cindy Thome
Denae Villines
Eilleen Wilbert
Lindsey 
Brew er(Previous 
SubI)Alliance for Multispecialty Research, LLC
700 Medical Center Dr, Ste 110
Newton, KANSAS 67114
UNITED STATES127 124
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 57
FDA-CBER-2021-5683-1072249
C4591001 Page 58of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Ragene 
Moore(Previous 
SubI)
1116 Paul Matherne Melissa Benke
Nancy Bladsacker
Sarah Bow en
Amy Caldwell
Ashley Dean -Reaves
Donald Gaddy
Kathrine Gaddy
Nicole Guttierrez
Megan Hill
Lindsay Huckabee
Heather Lambert
Tiffany Payne
Connie Richardson
Laura Singley
Jessica Stahl
Dimitri Yanez
Valerie 
Velasco(Previous 
SubI)MedPharmics, LLC
15190 Community Rd, Ste 300
Gulfport, MISSISSIPPI 39503
UNITED STATES326 314
1117 Larkin 
Wadsw orthJennifer Berry
Lyly Dang
Horacio MarafiotiSundance Clinical Research, LLC
711 Old Ballas Rd, Ste 105
St. Louis, MO 63141
UNITED STATES199 183
1118 Frank Eder Victoria Engler
Ryan Little
Jennifer Molstead
Heather Rattenbury 
ShawMeridian Clinical Research, LLC
1290 Uppr Frnt St
Binghamton, NEW YORK 13901
UNITED STATES130 129
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 58
FDA-CBER-2021-5683-1072250
C4591001 Page 59of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
John Tarbox
1120 Paul Bradley Shanice Bennett
Anne Crouch
Shannon Davis
Brooke Halpern
Amanda Lilienthal
Doungphon Nelson
Kay Lynn 
Olmsted(Previous 
SubI)Meridian Clinical Research, LLC
340 Eisenhower Dr, Ste 1200
Savannah, GA 31406
UNITED STATES434 370
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 120
1122 Curtis Donskey Federico Perez
Margaret TiktinVA Northeast Ohio Healthcare System
10701 E Blvd.
Cleveland, OHIO 44106
UNITED STATES57 54
1123 Brandon Essink Laura Falcone Meridian Clinical Research 408 396
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 59
FDA-CBER-2021-5683-1072251
C4591001 Page 60of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Roni Gray
Linda Layton
Jay Meyer
Frederick Raiser
Jacob 
Bumsted(Previous 
SubI)
Kimberly 
Mueller(Previous 
SubI)
Tiffany 
Nem ecek(Previous 
SubI)3319 N 107th St.
Omaha, NEBRASKA 68134
UNITED STATES
1124 David Fried Jacqueline DiFazio
Patricia Feole
Kristina Haughey
Lynne Haughey
Courtney Langlois
Amanda O'Neill
Johnna Pezzullo
Lisa Rameaka
Molly Savitzky
Ariana Stanton
Amanda 
Cole(Previous SubI)Omega Medical Research
400 Bald Hill Rd
Warw ick, RHODE ISLAND 02886
UNITED STATES235 235
1125 Charles Harper Alisha Kiepke
Cathy Laflan
Wendell Lewis
Brett Loseke
Chelsie Nutsch
Kari UhlirMeridian Clinical Research, LLC
1410 N 13th St, Ste 5
Norfolk, NE 68701
UNITED STATES238 213
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 60
FDA-CBER-2021-5683-1072252
C4591001 Page 61of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Keith Vrbicky
1126 Nicola Klein Rebecca Alexander
Janelle Baires
Jessica Barraza
Lauren Fontenot
Lisa Kennedy
Shannon Mullen
Ken Purdy
Sally Upadhyaya
Dana Weisshaar
Amy Wiesner
Julia 
Glanternik(Previous 
SubI)
Rebekah 
Kotyk(Previous SubI)Kaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES211 211
Kaiser Permanente Santa Clara
710 law rence expy
Santa Clara, CA 95051
UNITED STATES
1127 Tracy Klein Nathan Bergkamp
Olivia Eagleson
Gregory Greer
Lisa Hemmelgarn
Diandra Henriques
Jill Hiebert
Denise Hole
Laura Holz
Terry Klein
Thomas Klein
Jill Longstaff
Jessie Matthe ws
Meenakshi Natesan
Loan Nguyen
Terry Poling
Christa ShueAlliance for Multispecialty Research, LLC
1709 S Rock Rd
Wichita, KS 67207
UNITED STATES114 108
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 61
FDA-CBER-2021-5683-1072253
C4591001 Page 62of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Brenna Sprout
Cindy Thome
Dem etria Underw ood
Ariel Wilken
Gina Young
Sandra 
Blaylock(Previous 
SubI)
Lynn Le(Previous 
SubI)
Taylor 
Simmons(Previous 
SubI)
1128 Mark Koch Norma Escamilla
Patricia Kaczmarski
Isaac Watemberg
James WinnVentavia Research Group, LLC
1307 8th Ave, Ste M1
Fort Worth, TX 76104
UNITED STATES385 376
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 STATES254 246
1130 Stephen 
FortmannTara Beatty
Bryan Kauffman
Dorothy Kurdyla
Richard Mularski
Katie Sharff
Britta Kaiser Permanente Northwest -Center for Health Research
3800 N Interstate Ave
Portland, OR 97227
UNITED STATES98 98
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 62
FDA-CBER-2021-5683-1072254
C4591001 Page 63of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Torgrimson -Ojerio
Eric Walter
1131 William Randall Heather Goins
Zachariah Komon
Ann Moell
Crystal Osman
Gilbert Templeton
Melissa 
Botts(Previous SubI)
Kimberly 
Lyons(Previous SubI)PriMED Clinical Research
948 Patterson Rd
Dayton, OHIO 45419
UNITED STATES264 236
1133 How ard 
SchwartzMaria Companioni
Barbara Corral
Surisaday Mederos
Americo Padilla
Nelia Sanchez -Crespo
Jennifer Schwartz
Peter VentreResearch Centers of America
7261 Sheridan St, Ste 210
Hollywood, FL 33024
UNITED STATES649 612
1134 Jonathan Wilson Robert Holmes
Danielle Reynolds
Brian Smith
Andrew  Stebich
Alissa VandykePMG Research of Winston -Salem , LLC
1901 S. Haw thorne Rd, Ste 306
Winston -Salem, NC 27103
UNITED STATES439 423
1135 Peter Winkle Riany Mirasol Cadag
Amina Haggag
Elizabeth 
Lee(Previous SubI)Anaheim Clinical Trials, LLC
1085 N. Harbor Blvd.
Anaheim, CA 92801
UNITED STATES570 538
Anaheim Clinical Trials, LLC
2441 W. La Palma Ave, Ste 140
Anaheim, CALIFORNIA 92801
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 63
FDA-CBER-2021-5683-1072255
C4591001 Page 64of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
UNITED STATES
1136 Michael Levin Marcy Kulic
Judith SalzWake Research -Clinical Research Center of Nevada, LLC
1022 E Sahara Ave
Las Vegas, NEVADA 89104
UNITED STATES111 103
1139 Emmanuel 
WalterMichael Smith
Geeta SwamyDuke University Medicine Circle -Duke Early Phase Clinical Research 
Unit
40 Duke Medicine Circle
Durham, NC 27710
UNITED STATES134 126
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
Institute for Human Performance
505 Irving Ave, Clinical Research Unit
Syracuse, NEW YORK 13210
UNITED STATES313 292
1141 Patricia 
WinokurJeffery Meier
Debra Pfab
Jack Stapleton
Laura StulkenUniversity of Iowa Hospitals & Clinics
200 Hawkins Dr
Iowa City, IA 52242
UNITED STATES269 259
University of Iowa Hospitals & Clinics Investigational Drug Services
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 64
FDA-CBER-2021-5683-1072256
C4591001 Page 65of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
200 Hawkins Dr, 01284 PFP
Iowa City, IOWA 52242
UNITED STATES
1142 Richard Rupp Megan Berman
Cori Burkett
Elizabeth Ginn
Laura PorterfieldUniversity of Texas Medical Branch
SIVS Clinical Trials Program, Primary Care Pavilion, 400 Harborside 
Dr., Ste 126
Galveston, TEXAS 77555
UNITED STATES309 296
1145 Kawsar Talaat Rachel Adkinson
Anna Durbin
Brittany Feijoo
Palmtama Grier
Noreen Hynes
Rachel Rokser
Beulah Sabundayo
Brittany 
Adjoodani(Previous 
SubI)Center for Immunization Research Inpatient Unit
Johns Hopkins Bayview Medical Center (JHBMC)
301 Mason Lord Dr, 4300
Baltimore, MD 21224
UNITED STATES113 104
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 STATES395 373
1147 Julia 
Garcia- DiazHailey Anderson
Melinda Benvenuti
Julie Castex
Freda Dunhurst
Jenna GriffinOchsner Clinic Foundation
1514 Jefferson Hwy
New  Orleans, LA 70121
UNITED STATES249 234
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 65
FDA-CBER-2021-5683-1072257
C4591001 Page 66of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Samuel King
James McMullen
Lisa 
Fredenburg(Previous 
SubI)
1149 Steven 
ReynoldsGregory Bonomo
Lee Dolowich
Haig Goenjian
Omid Omidvar
Lara Shirikjian
Seanglong TeCollaborative Neuroscience Research, LLC
12772 Valley View St, Ste 3
Garden Grove, CA 92845
UNITED STATES344 336
Collaborative Neuroscience Research, LLC
2600 Redondo Ave, Ste 415
Long Beach, CA 90806
UNITED STATES
Collaborative Neuroscience Research, LLC
2600 Redondo Ave, Ste 500
Long Beach, CA 90806
UNITED STATES
1150 Shelly Senders Sarah Ball
Elizabeth Bucchieri
Laura Caserta
Kelly Kelmes
Jennifer McKinnon
Katie Passarell
Jill Sangree
Allison 
Effron(Previous SubI)
Keili 
Mistovich(Previous 
SubI)
Eliza Senders Pediatrics
2054 S Green Rd
South Euclid, OH 44121
UNITED STATES149 145
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 66
FDA-CBER-2021-5683-1072258
C4591001 Page 67of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Pereira(Previous 
SubI)
1152 Donald Brandon William Davis
Daniel LawlerCalifornia Research Foundation
4180 Ruffin Rd, Ste 255
San Diego, CALIFORNIA 92123 -1881
UNITED STATES588 576
1156 Hector 
RodriguezArmando Acevedo
Armando Garcia
Yeniska Hall Nieves
Lizz Hernandez Diaz
Iris Izquierdo
Elaine Martinez
Alina Monteagudo 
Canto
Israel ZagalesAcevedo Clinical Research Associates
2400 Nw  54th St
Miami, FL 33142
UNITED STATES300 295
1157 Jamshid Saleh Marisol Angel 
Corrales
Candice Cabading
Marla Clark
Stephanie Clayton
Emily Crews
Amber Falconer
Carmen Flores
Alisha Garcia
Rafael Lupercio
Vicky Martin
Matthew Miles
Sarah Sandberg
Mohamed YassinParadigm Clinical Research Center
3652 Eureka Way
Redding, CA 96001
UNITED STATES178 172
1161 Darrell Warren Conway Benchmark Research. 44 43
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 67
FDA-CBER-2021-5683-1072259
C4591001 Page 68of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Herrington Dacia Corder
Krystal Doucet
Priscilla Garcia
Kayla Gibbs
Jaime Hyatt
Pricilla Percifield
Ivon Reveles
Vanessa Sanchez
Blanca Valdez
Melissa White
Shawnna White
Cambree 
Allison(Previous 
SubI)
Cynthia 
Dukes(Previous SubI)
Tina Goltl(Previous 
SubI)
Elyza 
Guerrero(Previous 
SubI)
Omega 
Hernandez(Previous 
SubI)
Priscilla 
Lozano( Previous 
SubI)
Pete 
Mendoza(Previous 
SubI)
Sierra 
Ramirez(Previous 
SubI)3605 Executive Dr
San Angelo, TEXAS 76904
UNITED STATES
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 68
FDA-CBER-2021-5683-1072260
C4591001 Page 69of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
1162 Robert 
RiesenbergMaria Johnson
Mark Lerman
Stanford Plavin
Leana WoodsideAtlanta Center for Medical Research
501 Fairburn Rd SW
Atlanta, GEORGIA 30331
UNITED STATES587 572
1163 George Bauer Edwin Adamson
Julie Bilich
Michael Cotugno
Lois Eaglin
Kim Harper
Charie Hynes
Brandon Illickal
Brenda Lawson
Kyra La wson
Jeffrey SegnerBenchmark Research
4517 Veterans Memorial Blvd
Metairie, LOUISIANA 70006
UNITED STATES146 142
1166 Mary  Beth 
ManningBrianna Arman
Toby Briskin
Sarah Dzigiel
Jennifer Gaston
Brooke Glivar
Lisa Hoagland
Briana Jackson
Amy Maroun
Denise Roadman
Joan Rothenberg
Megan Sokolowski
Karly Tarase
Sharita 
Tedder -Edwards
Devan Patel(Previous 
SubI)Rapid Medical Research, Inc.
3619 Park E Dr, Ste 300
Cleveland, OH 44122
UNITED STATES107 106
1167 Emily Shane Daniell Holston Medical Group 232 229
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 69
FDA-CBER-2021-5683-1072261
C4591001 Page 70of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Moraw ski Lisa Davis
Amanda Donoho
Ashley Helton
Curtis Jantzi
Anna Johnson
David Morin
Lori Ray
Emily Whitaker105 W Stone Dr, 3rd Fl, Ste 3B
Kingsport, TN 37660
UNITED STATES
1168 Steven Cox Lindsay Flaming
Angela Genovese
Aja George
Shanda Gow er
Karen Hames
Sharla ListerLynn Institute of Norman
630 24th Ave Sw
Norman, OKLAHOMA 73069
UNITED STATES240 239
1169 Joseph Yozviak Kristen Cornell
Thomas Eames
Brian Friel
Timothy Friel
Marcelo Gareca
Margaret 
Hoffman -Terry
Terry Kloiber
Mark Knouse
Arun Mancheril
Hugh Marsh
Jean Novak
Andrew  Orzel
Carla Rossi
Amy Slenker
Nicholas TraskLehigh Valley Health Network/Network Office of Research and 
Innovation
17th & Chew Streets
Allentown, PA 18102
UNITED STATES75 75
1170 Mezgebe Berhe Christopher Bettacchi North Texas Infectious Diseases Consultants, P.A. 497 494
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 70
FDA-CBER-2021-5683-1072262
C4591001 Page 71of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
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)3409 Worth St, Ste 710, 725, 740
Dallas, TEXAS 75246
UNITED STATES
1171 Earl Francis 
MartinMuhammad Irfan
Earl EdwardMartin
Monica Murray
Amy Starr
Insiya 
Valika(Previous 
SubI)DM Clinical Research
13406 Medical Complex Dr, Ste 53
Tom ball, TX 77375
UNITED STATES306 303
Martin Diagnostic Clinic
710 Law rence St
Tom ball, TX 77375
UNITED STATES
1174 Donald Poretz Amber Edelman
Malika Welborn
David WheelerClinical Alliance for Research & Education -Infectious Diseases, LLC 
(CARE -ID)
3289 Woodburn Rd, Ste 250
Annandale, VA 22003
UNITED STATES71 68
Infectious Diseases Physicians, LLC
3289 Woodburn Rd, Ste 200
Annandale, VA 22003
UNITED STATES
1177 David Cindy Pau East-West Medical Research Institute 565 565
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 71
FDA-CBER-2021-5683-1072263
C4591001 Page 72of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Fitz-Patrick Sian Smowton 1585 Kapiolani Blvd, Ste 1500
Honolulu, HI 96814
UNITED STATES
1178 Stephan Sharp Michael Caldw ell
Stacy Cox
Michael Hutson
Deborah Jamison
Deidre Lanier
Leanne Martin
Kathryn McNally
Audrey Quickel
Linda Schipani
Allison Sochovka
Robert Stokes
Wendy Tidw ellClinical Research Associates, Inc.
1500 Church St, Ste 100
Nashville, TN 37203
UNITED STATES317 314
1179 Steven Katzman Michael Potes
Khalid RaoMichigan Center for Medical Research
30160 Orchard Lake Rd
Farm ington Hills, MI 48334
UNITED STATES174 173
1204 Judith Aberg Deena Altman
Tarashon Broomes
Alina Jen
Sean Liu
Farah Rahman
Erika Maria Reategui 
Schwarz
Michelle 
Cespedes(Previous 
SubI)
Dana Mazo(Previous 
SubI)Icahn School of Medicine at Mount Sinai
1450 Madison Ave, Annenberg B2, Rm 204
New  York, NY 10029
UNITED STATES290 279
Icahn School of Medicine at Mount Sinai
17 E 102nd st, 8th fl
New  York, NY 10029
UNITED STATES
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 72
FDA-CBER-2021-5683-1072264
C4591001 Page 73of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Sondra 
Middleton(Previous 
SubI)
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 STATES20 20
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 Ritchie
Kristen Roessler
Daniel VandeRiet
Robert WeatherholtzChinle Comprehensive Health Care Facility
US Hwy 191 and Hospital Rd
Chinle, ARIZONA 86503
UNITED STATES39 38
Johns 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 VandeRietJohns Hopkins Center for American Indian Health
3 Cottonw ood St
Shiprock, NEW MEXICO 87420
UNITED STATES48 39
Northern Navajo Medical Center
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 73
FDA-CBER-2021-5683-1072265
C4591001 Page 74of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Robert Weatherholtz 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 STATES40 34
Johns Hopkins Center for American Indian Health
501 E. Nizhoni Blvd, Ste B
Gallup, NEW MEXICO 87301
UNITED STATES
1223 Onyema 
OgbuaguLaurie Andrews
Thilinie 
Bandaranayake
Melissa Campbell
Frances Santiago
Jessica TuanYale Center for Clinical Investigations (CSRU)
2 Church St S, Ste 114
New  Haven, CT 06519
UNITED STATES265 251
Yale University
School of Medicine
135 College St, Ste 392
New  Haven, CT 06510
UNITED STATES
Yale -New Haven Hospital
55 Park St, LL -15
New  Haven, CT 06511
UNITED STATES
1224 Larry Odekirk Christina Gallegos
John McLaughlin
Mark Nathanson
Kelly Radin
Cheri Castro(Previous Lynn Institute of Denver
1411 S. Potomac St, Ste 420
Aurora, CO 80012
UNITED STATES163 163
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 74
FDA-CBER-2021-5683-1072266
C4591001 Page 75of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
SubI)
Veronica 
Gonzales(Previous 
SubI)
Kristine 
Rausch(Previous 
SubI)
1232 Jeffrey Kingsley April Pixler IACT Health
800 Talbotton Rd
Colombus, GA 31904
UNITED STATES435 429
1235 John Vanchiere Pat Bass
Paul CooperLSUHSC -Shreveport
1501 Kings Hwy
Shreveport, LA 71103
UNITED STATES228 223
LSUHSC -Shreveport Clinical Trials Office
1801 Fairfield Ave, Ste 203
Shreveport, LA 71101
UNITED STATES
1248 Mohamed 
Al-IbrahimPaolo DePetrillo
Katarzyna Fraczek
Albert Fuzayl
Michael MorganPharm aron CPC, Inc.
800 W Baltimore St, 5th and 6th Fl
Baltimore, MARYLAND 21201
UNITED STATES252 238
1251 Hayes Williams Gary  Boyd
LaShondra Cade
Aileen Cunningham
Connie MoyaBirmingham Clinical Research Unit
2017 Canyon Rd, Ste 41
Birmingham, ALABAMA 35216
UNITED STATES264 256
1252 Stephen Grubb Tom  Christensen
Krystal HillMain Street Physician's Care
3612 Mitchell St40 39
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 75
FDA-CBER-2021-5683-1072267
C4591001 Page 76of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Steven Price Loris, SOUTH CAROLINA 29569
UNITED STATES
1254 Robert Heller Monica Lee
Michael PakdamanBayview Research Group
12626 Riverside Dr, Ste 404
Valley Village, CALIFORNIA 91607
UNITED STATES213 206
1258 Martin Schear Missy Chapman
Amy Hitchler
Tammy Jo LillyDayton Clinical Research
1100 Salem Ave
Dayton, OH 45406
UNITED STATES74 74
1260 Robert Finberg Carol Ciccarelli
Mary  Dawn Co
Kaethe Giaquinto
John Haran
Jaclyn Longtine
Karen Longtine
Juan Perez Velazquez
Bethany Trainor
Jennifer Wang
Mireya WessolosskyUMass Memorial Medical Center
ONC/Research Pharmacy
362 Plantation St, Ambulatory Care Center, Rm AC 6.058 (6th floor)
Worcester, MA 01655
UNITED STATES132 130
UMass Memorial Medical Center -University Campus
55 Lake Ave N
Worcester, MASSACHUSETTS 01655
UNITED STATES
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
Richard Harper
Nicholas Kenyon
Brian MorrisseyUC Davis Medical Center
2315 Stockton Blvd
Sacramento, CA 95817
UNITED STATES229 226
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 76
FDA-CBER-2021-5683-1072268
C4591001 Page 77of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Susan Murin
Justin Oldham
Christian Sandrock
Nam ita Sood
Ken Yoneda
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 178
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 STATES142 141
1270 Nicola Klein Rebecca Alexander
Janelle Baires
Jessica Barraza
Latisha Burun
Christine Cash
Gail Cook
David Cooper
Jolynne Encarnacion
Lauren Fontenot
LaVonne Freed
Sarah Kang
Lisa KennedyKaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES155 155
Kaiser Permanente Santa Clara
710 law rence expy
Santa Clara, CA 95051
UNITED STATES
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 77
FDA-CBER-2021-5683-1072269
C4591001 Page 78of 78
CONFIDENTIAL 19-Nov-2020 13:39:50 GMT
        Study 
Site 
NumberPrincipal 
Investigator Sub-Investigator Study Conducted at Address(es)Subjects 
Screened 
per SiteSubjects 
Randomized/
Entered per Site
Rom a Kullar
Ludy Lemus
Eva Lowe
Lorrie Lowe
Shannon Mullen
Courtney Oxandale
Ken Purdy
Sally Upadhyaya
Dana Weisshaar
Amy Wiesner
090177e1959b6a19\Approved\Approved On: 26-Nov-2020 02:33 (GMT) 
Page 78
FDA-CBER-2021-5683-1072270
Protocol C4591001
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
Covance Central Laboratory  Servic es
8211 S ciCor Drive
Indianapolis, IN 46214
United S tatesSafety  labs: hematology  panel 
(hemoglob in, complete blood count with 
differential, and platelets); blood 
chemistry  (ALT, AST, alkaline 
phosphatase, total bilirubin, BUN, and 
creatinine)
Screening la bs:HIV, HBsAg, HBc Ab, 
HCV Ab
CRF Health Management L imited, an 
affiliate of Bracket Global LLC
Ground Floor
Waterfront Building
Manbre Road
Hammersmith
London
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
090177e195962a13\Approved\Approved On: 26-Nov-2020 02:31 (GMT) 
Page 79
FDA-CBER-2021-5683-1072271
Protocol C4591001
16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 2CRO or Vendor Name and Address( es) Service Conducted
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
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
University  of Texas Medical Branch
Depar tment of Biochemistry  &Molecular 
Biology
University  of Texas Medical Bran ch
Galveston, TX 77555 -1055
United St atesSARS -CoV-2 Serum Neutrali zation 
Assay –NT50 and NT90
090177e195962a13\Approved\Approved On: 26-Nov-2020 02:31 (GMT) 
Page 80
(b) (4), (b) (6)
FDA-CBER-2021-5683-1072272
Protocol C4591001
16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 3CRO or Vendor Name and Address( es) Service Conducted
VerilyLife Scie nces LLC
269 East Grand Ave nue
South San Francisco, C A 94080
United Sta tesRecruitment Services
090177e195962a13\Approved\Approved On: 26-Nov-2020 02:31 (GMT) 
Page 81
FDA-CBER-2021-5683-1072273