A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

This study will be conducted as a separate investigation, as a follow-up of the randomized
exposure period of the original study, extending the exposure from Week 26 (Visit 10 [V10])
to Week 52 (Visit 16 [V16]), and will be using the same sites.

Subjects will continue to use the product they were randomized to in the original study
ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Inclusion Criteria:

- Subject completed V10 of the original study (ZRHR-ERS-09-US).

- The subject is willing to comply to study procedures and to continue to use the
product he/she was allocated to during the original study (THS 2.2 or CC) for an
additional 26 weeks at V10.

- Subject has given written informed consent to enter the 26-week extension study at
V10.

Exclusion Criteria:

- Clinically relevant medical conditions that in the opinion of the investigators would
jeopardize the safety of the participant.

- As per judgment of the PI(s) or designee(s), the subject cannot participate in the
study for any reason (e.g. medical, psychiatric and/or social reason).

- Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS
2.2) during the original study.

- Female subject is pregnant or breast feeding.

- Female subject who does not agree to use an acceptable method of effective
contraception.