Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence

Main Inclusion Criteria: * Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF. * Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last \>6 months). * Subject has continuously smoked on average ≥10 commercially available mentholated or non-mentholated CIGs per day over the last 4 weeks prior to screening and admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL). * Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history). Main Exclusion Criteria: * Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject. * Subject experienced within 30 days prior to screening/admission a body temperature \>37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) * As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g.,…