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Table 1 Study endpoints

From: A randomised, controlled, two-Centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional cigarette to a tobacco heating product

BoE Abbreviation Associated Toxicant Matrix
 Carbon monoxide CO Carbon monoxide Exhaled breath
 Total nicotine equivalents (nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates) TNeq Nicotine Urine
 Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol Total NNAL 4 (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) Urine
 Total N-nitrosonornicotine Total NNN NNN Urine
 3-hydroxypropylmercapturic acid 3-HPMA Acrolein Urine
 3-hydroxy-1-methylpropylmercapturic acid HMPMA Crotonaldehyde Urine
 S-phenylmercapturic acid S-PMA Benzene Urine
 Monohydroxybutenyl-mercapturic acid MHBMA 1,3-butadiene Urine
 2-cyanoethylmercapturic acid CEMA Acrylonitrile Urine
 4-aminobiphenyl 4-ABP 4-Aminobiphenyl Urine
 o-toluidine o-Tol o-Toluidine Urine
 2-aminonaphthalene 2-AN 2-Aminonaphthalene Urine
 1-hydroxypyrene 1-OHP Pyrene Urine
 2-hydroxyethylmercapturic acid HEMA Ethylene oxide Urine
 N-acetyl-S-(2-carbamoylethyl)cysteine and N-acetyl-S-(2-hydroxy-2-carbamoylethyl)cysteine AAMA and GAMA Acrylamide Urine
BoBE Abbreviation Biological Effect Matrix
 8-Epi-Prostaglandin F2α Type III 8-Epi-PGF2α Type III Oxidative stress Urine
 White blood cell count WBC count Inflammation Whole blood
Nicotine pharmacokinetic parameters Abbreviation
 Time to maximum observed plasma concentration for nicotine tmax
 Maximum observed plasma concentration for nicotine Cmax
 Area under the nicotine plasma concentration-time curve from time zero to the last measurable concentration AUC0-last
Safety parameters Other measures
 Medical history of study subjects Product satisfaction questionnaire
 Physical examination Puff count during pharmacokinetic assessment period
 Vital signs Creatinine concentration (24-h urine)
 Electrocardiogram (ECG) Product use during exposure phase
 Clinical laboratory evaluations Nicotine molar metabolite ratio
 Lung function test  
 Adverse event /serious adverse event recording  
  1. BoE biomarker of exposure, BoBE biomarker of biological effect