A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products

Inclusion criteria

• Ability to read, understand, and be willing to sign an ICF and complete questionnaires written in English.
• Generally healthy male or female, between age 21-65 years (inclusive at the time of consent), verified with government-issued identification.
• All female (assigned at birth) candidate participants and those who identify as "intersex" or "unknown" during screening who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
• Self-report currently smoking at least five CPD on smoking days in the past 30 days.
• Smoke CC on at least 27 days out of last 30 days.
• Have smoked at least 100 factory-made filtered CC in their lifetime prior to SEV.
• Indicate a willingness to use an HTP.
• Agree to participate in the study and to abide by the study restrictions and requirements, including the use of the assigned Study IP, as described in the ICF.
• Agree not to allow any other person to use any product provided to them for use during this study.

Exclusion criteria

• Female participants who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next 6 months from the study start date.
• Women who self-report they are not intending to use adequate contraception methods to prevent pregnancy.

a) Examples of acceptable contraception methods are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); ii. Established use of oral, implantable, injectable, or transdermal methods of contraception associated with inhibition of ovulation; iii. Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; iv. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); v. Vasectomized partner; vi. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and vii. Post-menopausal who are not on hormone replacement therapy.

• Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
• Individuals who self-report having pacemakers or other embedded electronic medical devices.
• Individuals who self-report having an unstable heart condition, severe hypertension or diabetes.
• Individuals who self-report they are sensitive to nicotine.
• Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
• Individuals who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
• Individuals who are employed by a company that manufactures tobacco, HTPs, marketing or in ongoing litigation with a tobacco company.
• Individuals who self-report that they are planning to quit all nicotine products in the next three months.
• Individuals who are personally, have household members, or have close family or friends in ongoing or past litigation with a company that manufactures tobacco or HTPs.
• People who have taken part in a tobacco/nicotine research study in the past 30 days.