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Table 6 Clinical laboratory tests

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

Serum biochemistry

Haematology

 Aspartate aminotransferase (AST)

 Haemoglobin

 Alanine aminotransferase (ALT)

 Haematocrit (packed cell volume [PCV])

 Alkaline phosphatase

 Total and differential leukocyte count

 Gamma-glutamyl transferase (GGT)

 Red blood cell (RBC) count

 Sodium

 Platelet count

 Potassium

 Mean cell volume (MCV)

 Chloride

 Mean cell haemoglobin (MCH)

 Calcium

 MCH concentration (MCHC)

 Inorganic phosphate

Urinalysis:

 Glucose

 Microscopic examination

 Urea

 pH

 Uric acid

 Specific gravity

 Total bilirubin

 Protein

 Direct bilirubin

 Glucose

 Creatinine

 Ketones

 Total protein

 Bilirubin

 Albumin

 Blood

 Total cholesterol

 Nitrite

 Triglycerides

 Urobilinogen

 Creatinine phosphokinase (CPK)

 Leukocytes

 Blood urea nitrogen (BUN)

 Urine pregnancy testd

Serologya

 Urine drug screene

 Hepatitis B surface antigen (HBsAg)

Additional Tests

 Hepatitis C antibody

 Alcohol breath test

 Human immunodeficiency virus (HIV)c

 Syphilis

 

Hormone Panelb

 

 Follicle-stimulating hormone (FSH)

 

 Human chorionic gonadotropin (hCG; serum pregnancy test)

 
  1. aScreening only
  2. bIn all females at screening only
  3. cHIV1/2 and p24 antigen
  4. dIn all females. A positive urine pregnancy test will be confirmed with a serum pregnancy test
  5. eUrine drugs of abuse screen will be conducted for amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methamphetamine, morphine, methadone, tricyclic antidepressants, and tetrahydrocannabinol