Clinical trial NCT01793883: Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Official title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza Laninamivir Octanoate
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-02-18
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

Detailed description: Approximately 636 subjects will be randomized into the Study.

Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

Eligibility criteria: Main Inclusion Criteria:

1. Provide written informed consent
2. Males or females aged 18-64 years, inclusive
3. Symptomatic presumptive influenza A or B infection defined as the presence of:

   1. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND
   2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
   3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)
4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

   1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
   2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
   3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

Main Exclusion Criteria:

1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
6. Presence of clinically significant signs of acute respiratory distress during screening
7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of \<60 mL/min
9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results

Primary outcomes:
measure: Time to Alleviation of Influenza Symptoms
timeFrame: Efficacy will be assessed over 14 days post-randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsboro
country: United States
facility: Scottsboro Quick Care Clinic
state: Alabama
city: Camp Verde
country: United States
facility: Clinical Trial Connection
state: Arizona
city: Chandler
country: United States
facility: Warner Family Practice
state: Arizona
city: Harrisburg
country: United States
facility: Clinical Research Connections, LLC
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Huntington Beach
country: United States
facility: Beach Physicians Medical Group, Inc.
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Long Beach
country: United States
facility: Novo Research, Inc.
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz, MD, Inc
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County, Inc
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine & Family Health Center
state: California
city: Tustin
country: United States
facility: Orange County Research Center, Inc
state: California
city: Upland
country: United States
facility: SC Clinical Research, Inc.
state: California
city: Northglenn
country: United States
facility: Complete Family Care
state: Colorado
city: Boca Raton
country: United States
facility: BRCR Medical Center, Inc DBA Boca Raton Clinical Research
state: Florida
city: Boynton Beach
country: United States
facility: Zasa Clinical Research, LLC
state: Florida
city: Chiefland
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Sanitas Research
state: Florida
city: Jacksonville
country: United States
facility: Southeast Clinical Research, LLC - Parent
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center, Inc
state: Florida
city: Orlando
country: United States
facility: DCT - FMC, LLC, d/b/a Discovery Clinical Trials
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Snellville
country: United States
facility: Dr. B. Abraham, PC
state: Georgia
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates P.A.
state: Idaho
city: Madisonville
country: United States
facility: Baptist Health Clinical Studies
state: Kentucky
city: Mandeville
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Metairie
country: United States
facility: Medipharmics, LLC
state: Louisiana
city: Natchitoches
country: United States
facility: KAMP Medical Research
state: Louisiana
city: Bangor
country: United States
facility: Paul Shapero, MD
state: Maine
city: Bethesda
country: United States
facility: Bethesda Allergy, Asthma & Research Center, LLC
state: Maryland
city: Fall River
country: United States
facility: Neccr Imca, Llc
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Bellevue
country: United States
facility: Pioneer Clinical Research, LLC
state: Nebraska
city: Bellevue
country: United States
facility: The Asthma & Allergy Center, P.C. master
state: Nebraska
city: Fremont
country: United States
facility: Beacom Family Health Connection
state: Nebraska
city: Las Vegas
country: United States
facility: eStudySite
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services, LLC
state: Ohio
city: Milford
country: United States
facility: Hometown Urgent Care & Occupational Health
state: Ohio
city: Sylvania
country: United States
facility: ProMedica Health System, Inc
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Lansdale
country: United States
facility: Detweiler Family Medicine & Associates
state: Pennsylvania
city: Warminster
country: United States
facility: Warminster Medical Associates, PC
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Columbia
country: United States
facility: Clinical Research Solutions, PC
state: Tennessee
city: Franklin
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Franklin
country: United States
facility: Clinical Research Solutions, PC
state: Tennessee
city: Jackson
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Solutions, PC
state: Tennessee
city: Smyrna
country: United States
facility: Clinical Research Solutions, PC
state: Tennessee
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical Research
state: Texas
city: San Antonio
country: United States
facility: DBA Southwest Clinic
state: Texas
city: San Antonio
country: United States
facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Clinton
country: United States
facility: Westside Medical
state: Utah
city: Draper
country: United States
facility: Focus Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research - FirstMed East
state: Utah
city: Roanoke
country: United States
facility: Carilion Infectious Disease
state: Virginia
city: Burwood
country: Australia
facility: Dr Doong's Surgery
state: New South Wales
city: Sydney
country: Australia
facility: Hyde Park Medical
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital
state: Queensland
city: Jimboomba
country: Australia
facility: Jimboomba Junction Family Practice & Skin Cancer Clinic
state: Queensland
city: Mermaid Beach
country: Australia
facility: Mermaid Beach Medical Centre
state: Queensland
city: Morayfield
country: Australia
facility: Morayfield 7 Day Medical Centre
state: Queensland
city: Sherwood
country: Australia
facility: AusTrials Pty Ltd. Sherwood
state: Queensland
city: Adelaide
country: Australia
facility: Pain & Anaesthesia Research Clinic
state: South Australia
city: Broadmeadows
country: Australia
facility: Hunter Clinical Research
state: Victoria
city: Borgerhout
country: Belgium
facility: Dokter Luc Timmermans
city: Halen
country: Belgium
facility: Vereecken Guy
city: Herbeumont
country: Belgium
facility: Calozet, Yven
city: Moerkerke
country: Belgium
facility: Hutsebaut, Andre
city: Moorsel
country: Belgium
facility: Van Mulders, Norbert
city: Mouscron
country: Belgium
facility: Parque, Jean-Luc
city: Oostham
country: Belgium
facility: Mortelmans, Jaak
city: Oudenaarde
country: Belgium
facility: Private Practice
city: Wetteren
country: Belgium
facility: BVBA Dr. Luc Capiau
city: Ruse
country: Bulgaria
facility: SHATPPD-Ruse EOOD
city: Sofia
country: Bulgaria
facility: DCARC "Hill Clinic"
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center II - Sofia OOD
city: Sofia
country: Bulgaria
facility: Fifth MHAT-Sofia, EAD
city: Sofia
country: Bulgaria
facility: MHAT "Lyulin", EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: NMTH "Tsar Boris III"
city: Sofia
country: Bulgaria
facility: UMHAT " Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Lozenets"
city: Veliko Tarnovo
country: Bulgaria
facility: MDHAT Dr Stefan Cherkezov, AD
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd
state: Ontario
city: Etobicoke
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Mirabel
country: Canada
facility: Omnispec Clinical Research Inc
state: Quebec
city: Quebec
country: Canada
facility: Clinique Medicale St-Louis (Recherche) Inc
city: Bogota
country: Colombia
facility: Administradora Country S.A.
city: Bogota
country: Colombia
facility: Centro de Investigacion Clinica - CAFAM
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
city: Paide
country: Estonia
facility: Vee Family Doctor's Center OY
city: Tallinn
country: Estonia
facility: Medicum Perearstikeskus AS
city: Tallinn
country: Estonia
facility: Meie Tervis OU
city: Tallinn
country: Estonia
facility: Merekivi Perearstid OU
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
city: Tallinn
country: Estonia
facility: Mustamae Health Centre
city: Tallinn
country: Estonia
facility: Pirita Family Doctors Centre
city: Tartu
country: Estonia
facility: Dr Monika Vask Ltd.
city: Voru
country: Estonia
facility: Marje Toom Family Doctors Practice
city: La Bouexiere
country: France
facility: Cabinet Medical
state: Ille Et Vilaine
city: Tours
country: France
facility: Cabinet Medical
state: Indre Et Loire
city: La Montagne
country: France
facility: Cabinet Medical
state: Loire Atlantique
city: Nantes
country: France
facility: Cabinet Medical - Alain Boye
state: Loire Atlantique
city: Briollay
country: France
facility: Cabinet Medical
state: Maine Et Loire
city: Murs-Erigne
country: France
facility: Cabinet Medical Jacques Marty
state: Maine Et Loire
city: Segre
country: France
facility: Cabinet Medical Jean Charcot
state: Maine Et Loire
city: Vihiers
country: France
facility: Cabinet Medical
city: Freiburg
country: Germany
facility: Institut fuer Praeventive Medizin Freiburg
state: Baden Wuerttemberg
city: Dietzenbach
country: Germany
facility: Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz
state: Hessen
city: Essen
country: Germany
facility: Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
state: Nordrhein Westfalen
city: Essen
country: Germany
facility: Hausarztzentrum Bocholder Strasse
state: Nordrhein Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein Westfalen
city: Essen
country: Germany
facility: Unterfrintroper Hausarztzentrum
state: Nordrhein Westfalen
city: Goch
country: Germany
facility: medicoKIT
state: Nordrhein Westfalen
city: Kamp-Lintfort
country: Germany
facility: Gemeinschaftspraxis Heisters und Sungen
state: Nordrhein Westfalen
city: Koein
country: Germany
facility: Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
state: Nordrhein Westfalen
city: Dresden
country: Germany
facility: ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
state: Sachsen
city: Hamburg
country: Germany
facility: Praxis Dr. Schiewe
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
city: Budapest
country: Hungary
facility: CSALADGYOGYYASZ Szolgaltato es Oktato Bt.
city: Budapest
country: Hungary
facility: Haziorvosi Rendelo
city: Budapest
country: Hungary
facility: QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft
city: Debrecen
country: Hungary
facility: Kenezy Korhaz es Rendelointezet
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Kecskemet
country: Hungary
facility: Felnott Haziorvosi Rendelo
city: Kecskemet
country: Hungary
facility: Haziorvosi Rendelo
city: Miskolc
country: Hungary
facility: Felnott Haziorvosi Rendelo
city: Nyiregyhaza
country: Hungary
facility: Revamed Kft.
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Balvi
country: Latvia
facility: Liga Kozlovska Family Doctor Practice
city: Jelgava
country: Latvia
facility: Jelgava Outpatient Clinic
city: Kuldiga
country: Latvia
facility: Dr. R. Eglite's Private Practice
city: Lielvarde
country: Latvia
facility: Dr. Dz.Trosk's practice
city: Liepaja
country: Latvia
facility: Regional Hospital of Liepaja
city: Rezekne
country: Latvia
facility: Hospital of Reseknes
city: Riga
country: Latvia
facility: Clinic of GP A.Lasmanis "ALMA"
city: Riga
country: Latvia
facility: Vecverdina Vizma - GP Practice
city: Mexico
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Centro de Investigacion Clinica GRAMEL S.C
state: Distrito Federal
city: Mexico
country: Mexico
facility: Facultad Mexicana de Medicina, Universidad La Salle A.C.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Hospital Angeles Lindavista
state: Distrito Federal
city: Mexico
country: Mexico
facility: Mexico Centre for Clinical Research S.A. de C.V
state: Distrito Federal
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
state: Estado De Mexico
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute S.C.
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)
state: Jalisco
city: Zapopan
country: Mexico
facility: Hospital de Especialidades Centro Medico Puerta de Hierro
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Hospital Universitario de Monterrey
state: Nuevo Leon
city: Durango
country: Mexico
facility: Nucleo Victoria de Investigacion Clinica S.C.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Christchurch
country: New Zealand
facility: Primorus Clinical Trials Ltd
city: Christchurch
country: New Zealand
facility: Shirley Medical Centre
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand Ltd
city: Remuera
country: New Zealand
facility: Auckland Family Medical Centre
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco
city: Lima
country: Peru
facility: Clinica Internacional Sede San Borja
city: Lima
country: Peru
facility: Clinica San Borja
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Port Elizabeth
country: South Africa
facility: Global Clinical Trials PE
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Iatros International
state: Free State
city: Bloemfontein
country: South Africa
facility: Josha Research
state: Free State
city: Welkom
country: South Africa
facility: Drs YAK Vahed and Partners
state: Free State
city: Johannesburg
country: South Africa
facility: Maphutha, MB
state: Gauteng
city: Johannesburg
country: South Africa
facility: Medicross Roodepoort Clinical Research
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
state: Gauteng
city: Krugersdorp
country: South Africa
facility: DJW Research
state: Gauteng
city: Mamelodi East
country: South Africa
facility: Synexus SA, Stanza Bopape Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Engelbrecht, I
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials Pretoria
state: Gauteng
city: Pretoria
country: South Africa
facility: Jongaie Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus SA - Watermeyer Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Syzygy Clinical Research Services Wilgers
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria Clinical Research Unit
state: Gauteng
city: Durban
country: South Africa
facility: De Villiers Clinical Trials
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Sebastian, Peter
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Synapta Clinical Research
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: van Rensburg, CJJ
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Vawda, ZFA
state: KwaZulu-Natal
city: Phoenix
country: South Africa
facility: Brookdale Clinical Research Centre
state: KwaZulu-Natal
city: Richards Bay
country: South Africa
facility: Richards Bay Trial Centre (Pty) Ltd
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Centre
state: KwaZulu-Natal
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
state: Limpopo
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre
state: Mpumalanga
city: Cape Town
country: South Africa
facility: Africa International Research
state: Western Cape
city: Cape Town
country: South Africa
facility: Allergy Diagnostic & Clinical Research Unit
state: Western Cape
city: Cape Town
country: South Africa
facility: Boyd, WV
state: Western Cape
city: Cape Town
country: South Africa
facility: Helderberg Clinical Trials Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
state: Western Cape
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Western Cape Clinical Trials
state: Western Cape
city: George
country: South Africa
facility: Excellentis Clinical Trial Consultants
state: Western Cape
city: Somerset West
country: South Africa
facility: Somerset West Clinical Trial Unit
state: Western Cape
city: Worcester
country: South Africa
facility: Clinical Projects Research SA (PTY) LTD
state: Western Cape
city: Ely
country: United Kingdom
facility: Staploe Medical Centre
state: Cambridgeshire
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery Research
state: Derbyshire
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
state: Devon
city: Watford
country: United Kingdom
facility: Sheepcot Medical Centre
state: Hertfordshire
city: Glasgow
country: United Kingdom
facility: CPS Ltd
state: Strathclyde
city: Coventry
country: United Kingdom
facility: Holbrook Lane Surgery
state: Warwickshire
city: Bradford-on-Avon
country: United Kingdom
facility: Bradford on Avon Health Centre
state: Wiltshire
Study officials:
affiliation: Biota Scientific Management Pty Ltd
name: John Lambert, PhD
role: STUDY_DIRECTOR
References: