Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02649556
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT02649556
Study Brief:
Protocol Section:
NCT02649556