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The Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis: Interim Policy Guidance. Geneva: World Health Organization; 2014.

Abbreviations

AIDS

acquired immunodeficiency syndrome

ART

antiretroviral therapy

BD

twice daily

CEA

cost effectiveness analysis

CEM

cohort event monitoring

CI

confidence interval

CHMP

Committee for Medicinal Products for Human Use

DDI

drug drug interaction

DoI

declaration of interests

DOT

directly observed treatment

DOTS

basic package that underpins the WHO Stop TB Strategy

DST

drug-susceptibility testing

ECG

electrocardiogram

EG

Expert Group

ERP

External Review Panel

EMA

European Medicines Agency

GTB

WHO Global TB Programme

GRADE

Grading of Recommendations, Assessment, Development and Evaluation

GRC

Guidelines Review Committee

HIV

human immunodeficiency virus

ITT

intention to treat

MDR-TB

multidrug-resistant tuberculosis

MIC

minimal inhibitory concentration

MGIT

mycobacteria growth indicator tube liquid culture system

MITT

modified intention to treat

NTP

national tuberculosis programme

OBR

optimized background regimen

PICO

population, intervention, comparator, outcome

PLHIV

people living with HIV

PMDT

programmatic management of drug-resistant tuberculosis

QT

the interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram

QTcF

QT interval corrected for heart rate according to the Fridericia method

RCT

randomized controlled trial

RR

relative risk

SAE

severe adverse event

SCC

sputum culture conversion

SRA

stringent regulatory authority

SSM

sputum-smear microscopy

TB

tuberculosis

TEAE

treatment-emergent adverse effects

USAID

United States Agency for International Development

XDR-TB

extensively-drug resistant tuberculosis

WHO

World Health Organization

Copyright © World Health Organization 2014.

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Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html).

Bookshelf ID: NBK299538