Study concept and design: Kieburtz, Tilley, Elm, Babcock, Hauser, Dewey, Kamp, Simon, Tanner.
Acquisition, analysis, or interpretation of data: Kieburtz, Elm, Hauser, Ross, A. Augustine, E. Augustine, Aminoff, Bodis-Wollner, Boyd, Cambi, Chou, Christine, Cines, Dahodwala, Derwent, Dewey, Hawthorne, Houghton, Kamp, Leehey, Lew, Liang, Luo, Mari, Morgan, Parashos, Perez, Petrovitch, Rajan, Reichwein, Roth, Schneider, Shannon, Simon, Simuni, Singer, Sudarsky, Tanner, Umeh, Williams, Wills.
Drafting of the manuscript: Kieburtz, Tilley, Elm, A. Augustine, E. Augustine, Aminoff, Hawthorne, Liang, Mari, Perez, Williams.
Critical revision of the manuscript for important intellectual content: Kieburtz, Elm, Babcock, Hauser, Ross, A. Augustine, E. Augustine, Aminoff, Bodis-Wollner, Boyd, Cambi, Chou, Christine, Cines, Dahodwala, Derwent, Dewey, Houghton, Houghton, Kamp, Leehey, Lew, Liang, Luo, Morgan, Parashos, Petrovitch, Rajan, Reichwein, Roth, Schneider, Shannon, Simon, Singer, Simuni, Sudarsky, Tanner, Umeh, Wills.
Statistical analysis: Tilley, Elm, Luo, Perez.
Obtained funding: Tilley, Ross, Boyd, Dewey, Kamp, Leehey, Petrovitch, Shannon, Simon.
Administrative, technical, or material support: Kieburtz, Babcock, A. Augustine, E. Augustine, Aminoff, Kamp, Mari, Perez, Williams.
Study supervision: Kieburtz, Tilley, Bodis-Wollner, Dewey, Kamp, Luo, Mari.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kieburtz reported serving as a consultant for National Institutes of Health (NIH) (National Institute of Neurological Disorders and Stroke [NINDS]), the US Food and Drug Administration (FDA), the US Veterans Administration, Acorda, Astellas Pharma, AstraZeneca, Auspex, Biotie, Britannia, Cangene, CHDI Foundation, Civitas, Clintrex, Cynapsus, INC Research, Intec, Isis, Lilly, Lundbeck, Medavante, Medivation, Melior Discovery, Neuroderm, Omeros, Otsuka, Pharm2B, Prothena/Neotope/Elan Pharmaceutical, Roche/Genentech, Sage Bionetworks, Serina, Stealth Peptides, Synagile, Teikoku Pharma, Titan, Upsher-Smith, US WorldMeds, Vaccinex, Voyager, and Weston Brain Institute; and receiving grants or research support from the NIH (National Eye Institute, NINDS, National Institute on Aging [NIA], Eunice Kennedy Shriver National Institute of Child Health and Human Development), the Michael J. Fox Foundation, and Teva. Dr Tilley reported receiving grant support from NINDS and receiving travel funding from the CHDI Foundation. Dr Elm reported receiving research grant support from NINDS and serving as a consultant for Teva. Dr Hauser reported receiving honoraria or payments for consulting AbbVie, Allergan, AstraZeneca, Biotie Therapeutics, Ceregene, Chelsea Therapeutics, Cleveland Clinic, Eli Lilly, GE Healthcare, Impax Laboratories, Neurocrine, Indus, Ipsen Biopharmaceuticals, Lundbeck, Merck/MSD, Noven Pharmaceuticals, Pfizer, Straken Pharmaceuticals, Targacept, Teva Pharmaceuticals Industries Ltd, Teva Neuroscience, Upsher-Smith Laboratories, GLG, UCB Pharma SA, University of Houston, US WorldMeds, Xenoport, Zambon Company, SpA, Pricespective LLC, HealthLogix, and Gerson Lehrman Group Inc. Dr Ross reported receiving funding support from NINDS. Dr E. U. Augustine reported receiving funding from NINDS. Dr Aminoff reported receiving research support from NINDS (U10 NS044460; AAV-hAADC-2-003 [site principal investigator]) and the National Parkinson Foundation (NPF). Dr Boyd reported receiving personal fees from Lundbeck and Auspex and receiving grants from Auspex, the Michael J. Fox Foundation, Parkinson Disease Foundation, AbbVie, CHDI Foundation, and NINDS. Dr Chou reported receiving research support from the NIH (NS44504-08) and serving as a consultant to Medtronic. Dr Dahodwala reported receiving grants from NINDS, NIA, Teva, and the Parkinson Council. Dr Dewey reported serving as a consultant for Teva Pharmaceuticals, US WorldMeds, Lundbeck, Acadia, Merz, Xenoport, and GE Healthcare and receiving speakers fees from Teva Pharmaceuticals, US WorldMeds, and UCB. Ms Kamp reported receiving a grant from the University of Rochester. Dr Leehey reported receiving a grant from the NIH and receiving personal fees from Guidepoint Global, Gerson Lehman Group, MEDAcorp, and the Health Practices Institute. Dr Lew reported serving as a consultant for Teva Neurosciences, Baxter, Auspex, UCB, Impax, US WorldMeds, and Ipsen. Dr Liang reported receiving a grant from NINDS to the Parkinson’s Institute; receiving research support from Impax Pharmaceuticals, Teva Neuroscience, the Michael J. Fox Foundation, Novartis, NPF, Merck-Serono, Merck, Adamas, Kyowa, Chelsea Therapeutics, Berg Pharma, and Acadia; receiving an honorarium from Teva Neuroscience; and that she is currently employed by, and holds stock options in, Neurocrine Biosciences. Dr Luo reported receiving grants from the NIH, the Movement Disorder Society, and the CHDI Foundation. Dr Mari reported that his institution has received grant support from the NIH, NPF, Michael J. Fox Foundation, AVID, and AbbVie. Dr Morgan receiving grant support from the NIH and NPF; receiving speaking fees from NPF and Teva; and serving as a consultant for Teva, Impax Labs, Veloxis, Lundbeck, UCB, and Noven. Dr Morgan reported receiving grants from the NIH and the NPF and receiving speaking and consulting fees from Teva. Dr Pérez reported receiving grant support from the NIH. Dr Petrovich reported receiving grant support from NINDS. Dr Simon reported receiving grant support from NINDS. Dr Simuni reported receiving research support from NPF, Teva, Impax, Synosia, Auspex, Serono, Phytopharm, NIH, Michael J. Fox Foundation, the Dixon Foundation, and the Parkinson Associated Risk Study; receiving consulting fees from Acadia, AbbVie, Allergan, Boehringer Ingelheim, GE Medical, Eli Lilly, Harbor, Ibsen, Impax, Lundbeck, Merz, NPF, Navidea, Teva, UCB, and US WorldMeds; receiving honoraria from Allergan, GE Medical, Ibsen, Teva, and UCB; and receiving educational grant support from GE Medical and Teva. Dr Sudarsky reported receiving a grant from the NIH. Dr Tanner reported receiving grant support from NINDS and serving as a consultant for Adamas (fees paid to institution), Impax (fees paid to institution), and Pfizer. No other authors reported disclosures.
Funding/Support: Financial support for the LS-1 study was provided by National Institute of Neurological Disorders and Stroke (NINDS) grant U01NS43128.
Role of the Funder/Sponsor: The NINDS had input as to the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication (required prior review by the NINDS data and safety monitoring board).
NET-PD Steering Committee: Karl Kieburtz, MD, MPH (principal investigator, coordination center), University of Rochester, Rochester, New York; Barbara Tilley, PhD (principal investigator, statistical center), University of Texas, Houston; Debra Babcock, PhD, MD, and Wendy Galpern, MD, PhD, National Institutes of Health, Bethesda, Maryland; Robert Hauser, MD, University of South Florida, Tampa; Connie Kawai, RN, BSN, CCRC, University of Southern California, Los Angeles; Brad A. Racette, MD, Washington University School of Medicine, St Louis, Missouri; Bernard Ravina, MD, MSCE, Voyager Therapeutics Inc, Cambridge, Massachusetts; Sue Reichwein, CCRC, University of Pennsylvania, Philadelphia; G. Webster Ross, MD, Pacific Health Research and Education Institute, Honolulu, Hawaii; Kathleen M. Shannon, MD, Rush University Medical Center, Chicago, Illinois; Oksana Suchowersky, MD, University of Calgary, Alberta, Canada; Caroline M. Tanner, MD, PhD, The Parkinson’s Institute, Sunnyvale, California; Jessie Tatsuno Roth, RN, BSN, University of California San Francisco. NET-PD Statistical Center (University of Texas Health Science Center at Houston): Keith Burau, PhD; Jordan Elm, PhD; Rong Ye, MS; and Adriana Pérez, MS, PhD. NET-PD Clinical Trials Coordination Center Staff (University of Rochester, Rochester, New York): Debbie Baker, AAS; Liana Baker, MPH; Susan Bennett, AAS; Lisa DeBlieck, MPA, CCRC; Debbie Frasier, BS; Irenita Gardiner, RN; Jennifer Harman, PhD, CCRP, CCRC; Cornelia Kamp, MBA; Laith Khadim, MD; Gina Lau, BS; Beverly Olsen, BA; Saloni Sharma, MD; David Shprecher DO; Ann Stoutenburg, CCRC; Christine Weaver, CCRP; and Renee Wilson, MA. NET-PD Consultants: Christopher Goetz, MD, Rush University Medical Center, Chicago, Illinois; David Ploth, MD, Medical University of South Carolina, Charleston. Data and Safety Monitoring Board: Cynthia R. Gross, PhD (chair), University of Minnesota, Minneapolis; Karen L. Bell, MD, Columbia University, New York, New York; Donna T. Chen, MD, MPH, University of Virginia Health System, Charlottesville; Robert Foley, MD, United States Renal Data System Coordinating Center, Minneapolis, Minnesota; David E. Levy, MD, Weill Cornell Medical College, New York, New York; Robert L. Rodnitzky, MD, University of Iowa College of Medicine, Iowa City. Oversight Board: K. Michael Welch, MD (chair), Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; M. Flint Beal, MD, Weill Medical College of Cornell University, New York, New York; Jeffrey L. Cummings, MD, University of California, Los Angeles, Alzheimer Disease Center; Diane DiEuliis, PhD, Health and Human Services, Washington, DC; David J. Edwards, PharmD, Wayne State University, Detroit, Michigan; Stanley Fahn, MD, and Bruce Levin, PhD, Columbia University, New York, New York; Russell G. Katz, MD, US Food and Drug Administration, Rockville, Maryland; Deborah B. Marin, MD, and C. Warren Olanow, MD, Mount Sinai School of Medicine, New York, New York; Jeffrey C. Martin, Esq, Goodwin Proctor LLP, Rockville, Maryland; Steven Piantadosi, MD, PhD, Cedars-Sinai Medical Center, Los Angeles, California; William J. Powers, MD, University of North Carolina School of Medicine, Chapel Hill; Alison Wichman, MD, National Institutes of Health, Bethesda, Maryland. NIH (National Institute of Neurological Disorders and Stroke [NINDS] Bethesda, Maryland): Debra Babcock, PhD, MD; Wendy Galpern, MD, PhD; John Marler, MD; Claudia Moy, PhD; Joanne Odenkirchen, MPH.
Additional Contributions: We would like to acknowledge the long-term efforts and commitment made by the LS-1 participants and their caregivers.
Correction: This article was corrected online on February 19, 2015, to add missing degree information for an author.