IPrEx Dec 21 Online Supplemental Clean
Supplementary AppendixThis appendix has been provided by the authors to give readers additional information about their work.Supplement to: Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention inmen who have sex with men. N Engl J Med 2010;363:2587-99. DOI: 10.1056/NEJMoa1011205.(This supplementary appendix was published on November 23, 2010, and updated December 29, 2010, at NEJM.org.)
Grant et alNEJM online supplementiPrEx StudyTable of ContentsThe iPrEx Team . 2J. David Gladstone Institutes Coordinating Center (San Francisco, USA)Investigaciones Medicas en Salud (Lima, Peru)Asociación Civil Impacta Salud y Educación (Lima, Peru)Asociación Civil Selva Amazónica (Iquitos, Peru)Fundación Ecuatoriana Equidad (Guayaquil, Ecuador)Instituto de Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz (Rio de Janeiro, Brazil)Projeto Praça Onze, Hospital Escola São Francisco de Assis, U.F.R.J. (Rio de Janeiro, Brazil)Division of Clinical Immunology and Allergy, School of Medicine, U.S.P. (Sao Paulo, Brazil)HIV Research Section, San Francisco Department of Public Health (San Francisco, USA)The Fenway Institute (Boston, USA)Research Institute for Health Sciences, Chiang Mai University (Chiang Mai, Thailand)Desmond Tutu HIV Centre and Department of Medicine, U.C.T. (Cape Town, South Africa)University of California, San Francisco (San Francisco, USA)DF/Net Research (Seattle, USA)Gilead Sciences (Foster City, USA)National Institutes of Health (Bethesda, USA)CRPMC (Rockville, USA)Bill and Melinda Gates Foundation (Seattle, USA)222233444455555555Supplemental Introduction . 6Supplemental Methods . 6Protocol developmentStudy populationsVisit ProceduresMonitoring and Promotion of Pill UseAdverse Event ReportingLab MethodsAnalytical PharmacologyStatistical MethodsSpecimens for the Pharmacology Analysis6677888910Supplemental Figures and Tables . 11Figure S1. HIV Testing Algorithm During Follow-UpTable S1. List of Excluded Nephrotoxic AgentsTable S2. Hepatitis B virus infection status at screening in enrolled populationTable S3. Perceived Group Assignment At Week 12 By Randomized GroupFigure S2. Sexual Practices by Randomization Group.Table S4. Participants With STIs By Visit And Randomization GroupFigure S3. Nausea and Weight Change by Randomization GroupFigure S4. Plasma RNA level and CD4 T Cell Count by Randomization GroupTable S5. Drug Resistance FindingsFigure S5. Specimens Used In The Nested Case Control Study Of Drug LevelsTable S6. Concordance of Drug Detection in Plasma vs. CellsTable S7. Case-Control Analysis Of HIV Infection And Detectable Drug.Table S8. Comparison Of Drug Detection By Adherence StrataTable S9. Laboratory Abnormalities by Randomization GroupTable S10. Clinical Adverse Events by MedDRA Preferred Term and Group.111213141516171819202123242528Supplemental Discussion . 33Supplemental References Cited. 351December 21, 2010
Grant et alNEJM online supplementiPrEx StudyThe iPrEx TeamJ. David Gladstone Institutes Coordinating Center (San Francisco, USA)Robert Grant (protocol chair); Vanessa McMahan (study coordinator); Mohamed Abdel-Mohsen, K.Rivet Amico, Robert Atchison, Mark Aurigemma, Larry Bragg, Patricia Defechereux, ChristopherEden, John Gagnon, Pedro Goicochea, Robert Hance, Jacqueline Javier, Jeanny Lee, Vivian Levy,Teri Liegler, Jeff McConnell, Megha Mehrotra, Aliza Monroe-Wise, Malu Robles, Timothy Schmidt,Luke Smith, Sophie Stephenson.Investigaciones Médicas en Salud (Lima, Peru)Javier Lama (principal investigator); Lorena Vargas (study coordinator); Carlos Alvarado, CarlosAnton, Wendy Bacilo, Laura Ballesteros, Melissa Barbieri, Julio Chamochumbi, Sergio Chavez,Claudia Christen, Michelle Cohen, Johnny Diaz, Rafael Egoavil, Natalia Fajardo, Roberto Flores,Vanessa Galvez, Julio Gilvonio, Marco Gonzales, Miguel Gonzales, Pedro Gonzales, EdgarGrados, Natalie Grant-Villegas, Monica Guevara, Rosmery Gutierrez, Ana Hernandez, FlorentinoHuayhua, Cesar Huerta, Liz Jacome, Rosario Leon, Martín Llancare, Pedro Llican, Karina Lozano,Yesica Magallanes, Maria Mamani, Kory Martinez, John McRae, Ysela Mendoza, VanessaMeneses, Wylmer Mercado, Cesar Morales, Miguel Morales, Carlos Mosquera, Jristo Novoa, EmilioOlortegui, Judith Orihuella, Keyla Pablo, Rosario Pachas, Jesus Peinado, Esmelin Perez, CarlaPorcille, Genaro Portal, Jessica Reque, Alexander Rios, Jessica Rios, Christian Rojas, ElizabethRojas, Carlos Romero, Eduardo Ruiz, Hugo Sanchez, Monica Sanchez, Luis Seminario, RullerSoto, Carolina Ticse, Mylena Tirado, Sara Tume, Rossana Vargas, Yolanda Vargas, CarlosVelasquez, Jorge Vergara, Patricia Zegarra.Asociación Civil Impacta Salud y Educación (Lima, Peru)Juan Vicente Guanira (principal investigator); María Esther Ramirez (study coordinator); Nair Aoki,Peter Brandes, Juanita Calderon, Cecilia Callirgos, Hector Caro, Luis Castillo, Ruben Castillo, LuisCastro, Johana Centenaro, Oscar Cevallos, Cecilia Chang, Margarita Del Castillo, Julio Dextre, AnaDiaz, Julio Espinoza, Juan Estacio, Marilu Farfan, Diana Flores, Vanessa Galvez, Carmela Ganoza,Nadia Garcia, Mirna Garrido, Oscar Guerra, Maria Esther Guevara, Michelle Huisa, GabrielaIbañez, Irma Izquierdo, Alex Jimenez, Julissa Juarez, Jesus Jurupe, Suyin Kochiu, Martin Lacherre,Percy Mantilla, Giselle Mejia, Melisa Meneses, Sonia Minaya, Sergio Mispireta, Richard Negron,Norma Noda, Jose Ojeda, Ifath Padilla, Edwin Palomino, Anamelba Peceros, Patricia Piña, DinaPopuche, Eberth Quijano, Alberto Quino, Indira Quispe, Luis Quispe, Bertha Ramirez, Eric Ramos,Guiliano Rojas, Pedro Rojas, Gerardo Rosas, Rafael Rosas, Carmen Salinas, Mario Salinas, JavierSalvatierra, Carmen Sanchez, Luis Sanchez, Paola Sanchez, Karin Sosa, Janet Soto, Maria delCarmen Suarez, Armando Talaverano, Anabeli Tataje, Ronny Tirado, Gilda Troncos, RobertoUrday, Eduardo Velarde, Marlene Verastegui, Karen Villanueva, Erika Ygnacio, Martin Ynguil.Asociación Civil Selva Amazónica (Iquitos, Peru)Wilfredo Martin Casapia Morales (principal investigator); Jorge Luis Baldeon Rios (studycoordinator); Angel Alva Montoya, Edith Alva Salas, Debora Alvarado Alvarado, Karen IsabelAntinori Jaen, Nat Frangoise Ayapi Vasquez, Ney Barboza Pizango, Irina Bernuy Heigghen, MarcoAntonio Calixtro Callan, Kelly Nora Carbonel Villanueva, Carmela Casapia Morales, Jorge CelisEstela, Monica Chauca Rosas, Fernando Correa Cajachagua, Kenny Karen Da Costa Ahuite,Armando del Castillo Panduro, Elia Diaz Diaz, Gloria Estrella Grandez, Rony Rolando FasabiIrarica, Anel Karina Flores Mayta, Julissa Garay Quiñones, Flor de Maria Garces Pimentel, AnthonyGomez Garcia, Dora Amelia Guarniz D'orazi, Renato Guedes Cacique, Paola Guerrero Anton, JuanCarlos Hinojosa Boyer, Luis Rafael Hoyle Ganoza, Alonso Huarmiyuri Zambrano, Yoko Long2December 21, 2010
Grant et alNEJM online supplementiPrEx StudyCampos, Chela Lopez Diaz, Jannina Jessica Lopez Yumbato, Percy Lozano Pilco, Rafael MacaDávila, Maria Magdalena Macedo Pinedo, Cesar Alberto Malqui Espino, Johan Marin Lizarraga,Silvia Marin Gonzales, Luis Medina Rengifo, Esmelda Montalvan Sandoval, Rocío Najar Rengifo,Ivonne Navarro del Aguila, Antonio Noronha Gomez, Luz Marina Olortegui Pezantes, Oswaldo OrtizTorres, Rocio del Pilar Panaifo Vela, Jimmy Panduro Babilonia, Darwin Paniagua Yumbato, JorgeParraguez de la Cruz, Javier Omar Peixoto Valdez, Angella Pereyra Otrera, Danny Perez Ledesma,Irma Perez Torres, Roxana Pezo Flores, Maritza Puray Chavez, Martin Querevalu Zapata, PatriciaQuispe Churata, Laura Reategui Vásquez, Margot Reategui Tobler, Ana Rimachi Quiroz, ClaudiaRojas Flores, Jhyanira Romero Guimack, Francisco Ruiz Hidalgo, Lilian Saavedra Sevillano, KarolaSanchez Lozano, Julio Sandoval Vega, Carlos Santana, Julio Cesar Siche Martinez, NancySolignac Ruiz, Arturo Tapullima Sangama, Rolan Tapullima Upiachihua, Allan Tello De La Puente,Jorge Enrique Tello Herrera, Willa Tello Freitas, Belud Torres Barata, Brenda Urday Ruiz, CarlosVela Vela, Esau Zevallos Molano.Fundación Ecuatoriana Equidad (Guayaquil, Ecuador)Orlando Montoya-Herrera (principal investigator); Telmo Eduardo Fernández Cadena (investigatorof record); Luis Fernando Galarza Hinojosa (study coordinator); Gonzalo Rigoberto AbarcaCaceres, Manuel Alejandro Alava Ruiz, Astrid Estefanía Almeida Herrera, Roger Giovanni AlvaradoPalma, Victor Eduardo Alvarez Crespo, Jazmin Maria Andrade Teran, Neptali Dolores AriasZambrano, Belgica Enriqueta Aviles Cerezo, Oscar José Aviles Ronquillo, Wilson Gonzalo BajañaGranja, Ricardo Jaime Carchipulla Almeida, Angela María Casal Cabrera, Ana Maria ChicaizaNaula, Julio Alfredo Diaz Moran, Laurice Roxana Diez Pingel, Alex Javier Esparza Sarango, AlexFernando Franco Acebo, Mercedes de Lourdes García Noboa, Luis Ediel Guiracocha Aquino, RuthAlerxandra Heleno Reina, Alex Alberto Jarrín Alvarez, Ana Isabel Loor Alcivar, Demetrio DionisioMagallanes Mansaba, Wendy Mariuxi Mattos Mattos, Alfredo Argenis Menendez Andrade,Washington Rafael Miranda Vera, Walter Hugo Montaleza Tomala, Soraya Cecilia Montero Vidal,Jacqueline Mercedes Ordinola Valdiviezo, Isabel Cecilia Palomino Alaus, Oswaldo EnriqueParrales Saldarriaga, Reinaldo Miguel Quinga Medina, Jimmy Wagner Rivadeneira Velasco, GuidoAntonio Romero Barzola, Danilo Javier Rosado Rodriguez, Cruz Maribel Salazar Luna, Sonia delCarmen Salinas Salinas, Deisi Alexandra Segura Alvarado, Jessica Lourdes Suarez Luque, EvelynPriscila Vargas Humanante, Hugo Santiago Vinces Asqui, Jorge Ricardo Yonfa Mejia, Miriam delCarmen Zambrano Zambrano.Instituto de Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz (Rio de Janeiro,Brazil)Valdilea Gonçalves Veloso dos Santos (principal investigator); Lucilene de Araújo Freitas (studycoordinator); Marcos Vinícius Souza de Almeida, Ricardo Henrique Freitas de Almeida, CarlaAlmeida Alves, Daniela Murta Amaral, Serafim Campos Armesto, Douglas de Carvalho Baeta,Debora Faber Barreto, Monica Bastos de Lima Barros, Luiz Ricardo Ciqueira Camacho, Edilanedos Santos A. Cardoso, Sandra Wagner Cardoso, Priscila Guedes de Carvalho, Cristiane ReginaViníssius de Castro, Wellington de Azevedo Cavalcanti, Douglas dos Santos Cordeiro, MarcellusDias da Costa, Nilo Martinez Fernandes, Manoel Noé Filho, Alexandre N Mathias França, Josias daSilva Freitas, Ruth Khalili Friedman, Kelly de Souza Gama, Ingebourg George, Maura LassanceGonzales, Beatriz Grinsztejn, Maria Regina Cotrim Guimarães, Brenda Regina de S. Hoagland,Tania Krstic, Flavia Marques Leitão, Flavia Cristina Serrão Lessa, Suelen Renata E. Marques,Roberta Campos Milan, Helga A. B. do Monte, Ronaldo Ismerio Moreira, Fernanda Caria Murta,Juliana dos Santos B. Neto, Ivan Neves Junior, Soraia de Oliveira Nogueira, Flávia Santos Oliveira,Marilia Santini de Oliveira, Monica derrico Pedrosa, Egydio Sampaio Pessanha, Valéria RitaTeixeira Ribeiro, Macio Antônio de Sá, Lucimar Santos Salgado, Ari Pedroso dos Santos Jr, JoséMiguel dos Santos, Toni Araújo dos Santos, Janaína Reis Xavier Senna, Aline Moreira da Silva,3December 21, 2010
Grant et alNEJM online supplementiPrEx StudyCynthia Correa da Silva, Silvio Rodrigues da Silva, Virginia Oliveira da Silva, Alexandre LuizMariano de Souza, Henry Edison Pereira de Souza, Leandro Amparo de Souza, Lúcia HelenaCardoso de Souza, Mauro Nacimento de Souza, Ulisses Padrão de Souza, Wivison Jorge deSouza Junior, Thiago Silva Torres.Projeto Praça Onze, Hospital Escola São Francisco de Assis, Universidade Federal do Rio deJaneiro (Rio de Janeiro, Brazil)Mauro Schechter (principal investigator); Monica Barbosa de Souza (site coordinator); CarinaBeppu Yoshida (study coordinator); Daniele Fernandes de Aguiar, Fernanda Baptista Alves, KarinaVieira Branco, José Cláudio Freitas Brazil, Diana Domingues Camara, Marcellus Dias da Costa,José Cláudio da Rosa Faulhaber, Selma Baia Ferreira, Rita Franco, Paula Silva Gama, RafaelQuaresma Garrido, Paulo Cesar Hammes, Fernanda Hernani, Roberto José Januário, SérgioCarlos Assis de Jesus Junior, Nádia da Silva Leal, Maria de Fatima Melo, Daniel Garcia Pereira daSilva Neto, Jorge M. Pedrosa, Luciano B. Pimentel, Gabriel da Costa Pires, Flávio Luis DomingosRamos, Alessandra da Motta Reis, Adryane Sampaio, Alzenira Oliveira dos Santos, Antônio Joséda Silva, José Roberto Grangeiro da Silva, Narda Nery Tebet, Beatriz de Oliveira Linhares Teixeira,Sandra Regina Barros Telles, Marcio Villard, Ana Lucia A. Weinstein.Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo(São Paulo, Brazil)Esper Georges Kallás (principal investigator); Ricardo Palacios (study coordinator); Julio AntonioPereira Araújo, Vivian Helena Iida Avelino-Silva, Ana Paula Batista, Daniel Bertevello, FlorênciaComello, Ligia Maria Portella Correa, Priscila Ramos Costa, Maria Candida de Souza Dantas,Daniele de Lima Franco, Ricardo Gambôa, Maria Teresa Maidana Giret, Daniella Costa Menezes eGonçalves, Jorge Kalil, Karina Tiemi Kondo, Fabio Eudes Leal, Marcelo Litvoc, Adriana da SilvaMaciel, Lais Campos Magalhães, Mariana Henrique Marques, Augusto Mathias, Edmilson Alves deMedeiros, João Luiz Miraglia, Zelinda M. B. Nakagawa, Ana Helena Paro, Flávia Pennachin,Andrea Macorin Pinheiro, Renata Rebelo, Ricardo Toledo Russo, Alessandro Saraiva, MarianaMelillo Sauer, Issler Moraes Silva, Leandro Fagundes Tarosso, Helena Tomiyama.HIV Research Section, San Francisco Department of Public Health (San Francisco, USA)Susan Buchbinder (principal investigator); Albert Liu (co-principal investigator); Hailey J. Gilmore,Kerry Murphy (study coordinators); Christopher Adams, Pedro Arista, Jose C. Asencios, RobertBlue, Scott Carroll, Sarah Colvano, Aaron Cook, Eric Day, Alfonso Diaz, Elizabeth Faber, JohnFarley, Scott Fields, Jonathan Fuchs, Stephen Funk, Allison Futeral, Mark Goldman, Sally Grant,Saly Holland, Shannon Huffaker, Risha Irby, Tauren Jones, Christine Joseph, Anthony Koester,Jennifer Lam, Rachel Langdon, Mike Levi, Clare Liu-Bell, David Lubensky, Libby Lucas, DeliaMalloy, Brian Martin, Qianya Martin, Tim Matheson, Corvette Moore, Gavin Morrow-Hall, ArvinDavid Nalos, Jim Nehira, Jonathan O'Campo, Bernadette Perez, Christina Perkins, Rose Quinones,Robyn Sera, Shoshana Silberman, Martin Soto, Andrea Teague, Tes Temelso, Belinda Van, JeffWhite, Diana Ng Wong, Joyce C. Ycasas.The Fenway Institute (Boston, USA)Kenneth Mayer (principal investigator); Chris Chianese, Jocelyn Trufant (study coordinators); CocoAlinsug, Matt Box, Shari Lynn Cole, Janet Dargon, Emelia Dunham, Mark Fallon, Marcy Gelman,Sinclair Lao, Vanessa Marquez, Jim Maynard, Ralph Miele, William O'Brien, Lori Panther, AmyPechukas, Jesse Ripton, Sara Rogers, Daniel Tu, Rodney Vanderwalker.4December 21, 2010
Grant et alNEJM online supplementiPrEx StudyResearch Institute for Health Sciences, Chiang Mai University (Chiang Mai, Thailand)Suwat Chariyalertsak (principal investigator); Pongpun Saokhieo (study coordinator); SineenartNimsakul (project manager); Kannika Boursuk, Prathabjit Bunsoy, Chonlisa Chariyalertsak, ChutimaCharuwat, Nuntisa Chotirosniramit, Karand Chunpen, Sirikwan Dokuta, Tobin Guarnacci, KasidechJaithapeang, Parinya Jongpaijitsakul, Chiraphorn Kaewkosaba, Quanhathai Kaewpoowat, MonthianKaibuddhiwat, Rassamee Keawvichit, Pranee Ketdechar, Paweena Khamdam, SurangchitKoottathep, Natthapol Kosashunhanan, Natthaporn Kosashunhanan, Arawan Larplertsakul,Sukanya Linpisarn, Sompit Maneerat, Veruree Manoyos, Sirianong Namwongprom, TuntigonNonraban, Pimsuda Panyawong, Waraporn Pasawad, Rujira Phutthitada, KittipongRungruengthanakit, Phuripath Somnoi, Radchanok Songsupa, Piyathida Sroysuwan, PatcharaphanSugandhaveha, Taweewat Supindham, Tidawan Techajal, Sunida Thetket, Sripun Tunjalern,Pakinee Tuntivate, Surasing Visrutaratna, Gamonchanok Waropassagone, Suthatip Wongsrithep,Antika Wongthanee, Kanlaya Wongworapat, Panuwat Wonkulab, Amornrat Yangnoi, MethaYiamwanichaphong.Desmond Tutu HIV Centre and Department of Medicine, University of Cape Town (CapeTown, South Africa)Linda-Gail Bekker (principal investigator); Peter Chodacki, Andrew Scheibe (co-investigators);Elizabeth Batist, Heidi Frieslich, Christina Hosken (study coordinators); Benjamin Brown, EarlBurrell, Megan Farrow, Nazli Forune, Lindsay Gcwabe, Christie Heiberg, Carmen Hoffman, BrianKanyemba, Nicola Killa, Kim Kocsis, Melanie Macclachla, Machlachlan, Simphiwe Mannie, AshrafMargeman, Daniella Mark, Mabuti Mkangel, Sidwell Ndevu, Caswell Ndobongwana, Daniel Ndzuzo,Bassi Nelson, Bulelwa Panda, Adiel Peters, Martha Qumaba, Kate Snyder, Belgrade Stuurman.University of California, San Francisco (San Francisco, USA)Scott Fields, David Glidden, Jonathan Manzo, Chuck McCulloch, Kathleen Mulligan, Kimberly Page,Steve Shiboski, Furong Wang.DF/Net Research (Seattle, USA)Tami Ahn, Jessica Annis, Lydia Browne, Brittini Callies, Eddie Carlson, Daisy Chen, DavidCoblentz, Pauline Houx, Becca Huff, Bill Larson, Taylor Marshall, Peter McDonnell, Curtis Olsen,Lisa Ondrejcek, Darryl Pahl, Scott Plusquellec, Jenae Post, Brian Postle, Joseph Prencipe, GavinRadkey, Theresa Shea, Patience Shelhorn, Amber Sims, Anne Tran, Dana Van Dalfsen, BoxunZhang.Gilead Sciences (Foster City, USA)Norbert Bischofberger, Richard Clark, Abboud Habr, Howard Jaffe, John C. Martin, Sabina Pfister,Marianne Poblenz, James F. Rooney, Farideh Said, Michael Wulfsohn, Winnie Young.National Institutes of Health (Bethesda, USA)David Burns, Blanca Castillo, Grace Chow, Joanne Csedrik, Carl Dieffenbach, Dennis O. Dixon,Mary Fanning, Alain Kouda, Ana Martinez, Cherlynn Mathias, Mark OʼCallahan, Manizhe Payton,Michael Proschan, Monica Ruiz, Usha Sharma, Bariatu Smith, Sheryl Zwerski.CRPMC (Rockville, USA)John Ferinde, Neeraja Putta.Bill and Melinda Gates Foundation (Seattle, USA)Stephen Becker, Robyn Eakle, Renee Ridzon, Kaisa Sakrison.5December 21, 2010
Grant et alNEJM online supplementiPrEx StudySupplemental IntroductionFew concepts for the prevention of sexual HIV transmission have been rigorously proven: of 37late-phase trials, only 6 have demonstrated a significant protective benefit.1,2 Tenofovir 1% vaginalgel had 39% efficacy in heterosexual women.2 All other successful prevention interventions wereclinic-based and directly observed, including enhanced services for sexually transmitted infections(STIs),3 male circumcision,4-6 and a vaccine candidate.7 None of the successful interventions areknown to be effective in men and transgender women who have sex with men (MSM), who carry amajor burden of the global epidemic.8,9Favorable characteristics of FTC/TDF for PrEP include the following: Both agents persist in activeforms in the body for long periods of time, allowing for once daily dosing. Neither agent hasinteractions with anti-tuberculosis therapy, hormonal contraception, feminizing therapy, or antimalarial agents. Both agents are used for treatment of HIV infection,10 for which they have a wellestablished safety profile, and are available in patented and generic formulations.Supplemental MethodsProtocol developmentThe trial was performed under US FDA IND #71,859 held by the NIH/NIAID/DAIDS. The study wasinitiated with protocol version 3 which included 4 sites in Peru and Ecuador. Version 4 of theprotocol was implemented at all sites in June 2008, including new sites in Brazil, South Africa,Thailand and the United States when co-funding from the Bill and Melinda Gates Foundationbecame available. The decision to expand the study was made prior to enrolling the first participantand aimed to
Roberta Campos Milan, Helga A. B. do Monte, Ronaldo Ismerio Moreira, Fernanda Caria Murta, Juliana dos Santos B. Neto, Ivan Neves Junior, Soraia de Oliveira Nogueira, Flávia Santos Oliveira,
Council for Interior Design Accreditation Council on Academic Accreditation in Audiology and Speech-Language Pathology National Accrediting Agency for Clinical Laboratory . Dec 2 Dec 1 Nov 30 Classes resume Dec 13 Dec 12 Dec 15 Last day of classes Dec 14 Dec 13 Dec 19 Reading day Dec 14 Dec 13 Dec 19 Commencement Dec 16-20 Dec 15-19 Dec 16-18 .
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Supplemental information within a month of institution. 37 C.F.R. § 42.123(a) (a) Motion to submit supplemental information. Once a trial has been instituted, a party may file a motion to submit supplemental information in accordance with the following requirements: (1) A request for
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