<SEC-DOCUMENT>0001654954-20-011247.txt : 20201019
<SEC-HEADER>0001654954-20-011247.hdr.sgml : 20201019
<ACCEPTANCE-DATETIME>20201019072103
ACCESSION NUMBER:		0001654954-20-011247
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20201019
FILED AS OF DATE:		20201019
DATE AS OF CHANGE:		20201019

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		201245225

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a4477c.htm
<DESCRIPTION>TRIXEO AEROSPHERE RECEIVES POSITIVE CHMP OPINION
<TEXT>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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</font><font style="color: rgb(0, 0, 0); font-family: Times New Roman; font-size: 13px;">1.
Trixeo Aerosphere receives positive CHMP opinion</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
19 October 2020 07:00 BST</font></div>
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&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Trixeo
Aerosphere&#xA0;</font><font style="color: #000000">recommended for
approval in the EU</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
by CHMP for the maintenance treatment of COPD</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Recommendation of triple-combination therapy based on</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
positive results from ETHOS and KRONOS Phase III
trials</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo&#xA0;Aerosphere</font><font style="color: #000000">&#xA0;(formoterol
fumarate/glycopyrronium bromide/budesonide) has been recommended
for marketing authorisation in the European Union (EU) for
maintenance treatment in adult patients with moderate to severe
chronic obstructive pulmonary disease (COPD) who are not adequately
treated by a combination of an inhaled corticosteroid (ICS) and
long-acting beta2-agonist (LABA), or a combination of a LABA and a
long-acting muscarinic antagonist.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Trixeo Aerosphere</font><font style="color: #000000">, a
triple-combination therapy, is approved under the brand
name&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;in Japan, China
and the US for patients with COPD.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the ETHOS Phase III trial in which&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">&#xA0;showed a
statistically significant reduction in the rate of moderate or
severe exacerbations compared with dual-combination
therapies&#xA0;</font><font style="font-style: italic; color: #000000">Bevespi
Aerosphere</font><font style="color: #000000">&#xA0;(glycopyrronium/formoterol fumarate) and
PT009 (budesonide/formoterol fumarate) over 52
weeks.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The recommendation for approval was also supported by data from the
KRONOS Phase III trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;In
both trials, the safety and tolerability
of&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">&#xA0;were consistent
with the profiles of the dual comparators.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Klaus Rabe, Professor of Pulmonary Medicine at the University of
Kiel, Director of the Department of Pneumology at Clinic
Grosshansdorf, Germany, Lead Investigator of the ETHOS trial and
National Co-ordinating Investigator of the KRONOS Phase III trial,
said: "Preventing exacerbations is central to the management of
chronic obstructive pulmonary disease, as exacerbations may cause
irreversible damage and disease progression. The triple-combination
therapy,&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere,</font><font style="color: #000000">&#xA0;has
demonstrated significant benefits in reducing moderate or severe
exacerbations in patients suffering from this debilitating
disease."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "Chronic obstructive pulmonary disease is now the
third leading cause of death globally and affects approximately one
in 10 adults over the age of 40 in Europe.&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">&#xA0;has
demonstrated strong clinical benefit when compared with
dual-combination therapies and this positive recommendation brings
us closer to providing a much-needed new treatment to patients in
Europe."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
COPD</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">3,4,5&#xA0;</font><font style="color: #000000">It
affects an estimated 384 million people</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">6</font><font style="color: #000000">&#xA0;and
is the third leading cause of death globally.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">7</font><font style="color: #000000">&#xA0;In
Europe, approximately 10% of adults over the age of 40 have
COPD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font><font style="color: #000000">&#xA0;Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">3</font><font style="color: #000000">&#xA0;A
single COPD exacerbation can have a negative impact on lung
function,</font><font style="font-size: 70%; vertical-align: top; color: #000000">9,10</font><font style="color: #000000">&#xA0;quality
of life</font><font style="font-size: 70%; vertical-align: top; color: #000000">11</font><font style="color: #000000">&#xA0;and
increase the risk of hospitalisation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12</font><font style="color: #000000">&#xA0;Additionally,
even one COPD exacerbation that results in hospitalisation
increases the risk of death.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13,14</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
ATHENA clinical trial programme</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The ETHOS and KRONOS Phase III trials are part of AstraZeneca's
ATHENA Phase III clinical trial programme
for&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">, which included more
than 15,500 patients globally across 11 trials.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
ETHOS is a randomised, double-blinded, multi-centre,
parallel-group, 52-week Phase III trial to assess the efficacy and
safety of&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">&#xA0;in symptomatic
patients with moderate to very severe COPD and a history of
exacerbation(s) in the previous year. The primary endpoint was the
rate of moderate or severe exacerbations.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Results
were published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="font-style: italic; color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
KRONOS is a randomised, double-blinded, parallel-group, 24-week,
chronic-dosing, multi-centre Phase III trial to assess the efficacy
and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Trixeo
Aerosphere</font><font style="color: #000000">&#xA0;in patients
with moderate to very severe COPD regardless of whether or not they
had an exacerbation in the previous year. The primary endpoints
were lung function parameters.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;Results
were published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet Respiratory Medicine</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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&#xA0;</font></div>
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References</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">1.&#xA0;&#xA0;&#xA0;Rabe KF, Martinez FJ, Ferguson
GT,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;Inhaled Triple Therapy
at Two Glucocorticoid Doses in Moderate-to-Very Severe
COPD.&#xA0;</font><font style="font-style: italic; color: #000000">N Engl J
Med</font><font style="color: #000000">&#xA0;2020; 383:
35-48.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0;&#xA0;Ferguson GT, Rabe KF, Martinez
FJ,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;Triple combination of
budesonide/glycopyrrolate /formoterol fumarate using co-suspension
delivery technology versus dual therapies in chronic obstructive
pulmonary disease (KRONOS): a double-blind, parallel-group,
randomised controlled trial.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet Respir
Med.</font><font style="color: #000000">&#xA0;2018; 6:
747-758.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">3.&#xA0;&#xA0;
GOLD. Global Strategy for the Diagnosis, Management and Prevention
of COPD, Global Initiative for Chronic Obstructive Lung Disease
(GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last
accessed: October 2020].</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">4.&#xA0;&#xA0; Laviolette L, Laveneziana P; ERS
Research Seminar Faculty. Dyspnoea: a multidimensional and
multidisciplinary approach.&#xA0;</font><font style="font-style: italic; color: #000000">Eur Respir
J</font><font style="color: #000000">. 2014; 43 (6):
1750-1762.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">5.&#xA0;&#xA0; May SM, Li JT. Burden of chronic
obstructive pulmonary disease: healthcare costs and
beyond.&#xA0;</font><font style="font-style: italic; color: #000000">Allergy Asthma
Proc</font><font style="color: #000000">. 2015; 36 (1):
4-10.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0; Adeloye D, Chua S, Lee
C,&#xA0;</font><font style="font-style: italic; color: #000000">et
al.</font><font style="color: #000000">&#xA0;Global Health
Epidemiology Reference Group (GHERG). Global and regional estimates
of COPD prevalence: Systematic review and
meta-analysis.&#xA0;</font><font style="font-style: italic; color: #000000">J Glob
Health.</font><font style="color: #000000">&#xA0;2015; 5 (2):
020415.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">7.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">Quaderi SA, Hurst JR.
The unmet global burden of COPD.&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Glob
Health Epidemiol Genom</font><font style="color: #000000; background-color: #FFFFFF">. 2018; 3: e4.
Published 2018 Apr 6. doi:10.1017/gheg.2018.1.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">8.&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-size: 13px; background-color: #FFFFFF">European
lung white book. 2013. Chapter 13 Chronic obstructive pulmonary
disease. Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/</font><font style="color: #000000; font-size: 13px; background-color: #FFFFFF">&#xA0;[Last
accessed: October 2020].</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">9.&#xA0;&#xA0;&#xA0;Halpin DMG, Decramer M, Celli
BR,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;Effect of a single
exacerbation on decline in lung function in
COPD.&#xA0;</font><font style="font-style: italic; color: #000000">Respiratory
Medicine</font><font style="color: #000000">&#xA0;2017; 128:
85-91.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0; Kerkhof M, Voorham J, Dorinsky
P,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">. Association between COPD
exacerbations and lung function decline during maintenance
therapy.&#xA0;</font><font style="font-style: italic; color: #000000">Thorax</font><font style="color: #000000">. 2020; 75 (9): 744-753.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">11.&#xA0;&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">Roche N, Wedzicha JA,
Patalano F,&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">et
al.</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;COPD
exacerbations significantly impact quality of life as measured by
SGRQ-C total score: results from the FLAME
study.&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Eur
Resp J</font><font style="color: #000000; background-color: #FFFFFF">.&#xA0;2017;&#xA0;50&#xA0;(Suppl
61): OA1487.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">12.&#xA0;&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">Rothnie KJ,
M&#xFC;llerov&#xE1; H, Smeeth L, Quint JK. Natural History of
Chronic Obstructive Pulmonary Disease Exacerbations in a General
Practice-based Population with Chronic Obstructive Pulmonary
Disease.&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Am
Jour of Resp Crit Care Med.</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;2018; 198 (4):
464-471.&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">13.&#xA0; Ho TW, Tsai YJ, Ruan
SY,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">. In-Hospital and One-Year
Mortality and Their Predictors in Patients Hospitalized for
First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A
Nationwide Population-Based Study.&#xA0;</font><font style="font-style: italic; color: #000000">PLOS ONE</font><font style="color: #000000">. 2014; 9 (12): e114866.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">14.&#xA0; Suissa S, Dell'Aniello S, Ernst P.
Long-term natural history of chronic obstructive pulmonary disease:
severe exacerbations and mortality.&#xA0;</font><font style="font-style: italic; color: #000000">Thorax</font><font style="color: #000000">. 2012; 67 (11): 957-63.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
19 October 2020</font></div>
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