This study tests the safety of a medicine called cytisinicline for people who smoke cigarettes or use e-cigarettes. Cytisinicline is taken in a 3 mg dose three times a day for 52 weeks. Participants should have been part of previous studies called ORCA-2, ORCA-3, or ORCA-V1. They should currently smoke or use nicotine e-cigarettes daily. Before joining, participants will be tested for carbon monoxide (CO) levels or cotinine (a substance that shows nicotine use) to confirm smoking habits. Participants must be ready to start cytisinicline the day after joining and be willing to quit smoking within 14 days. They will also receive support to help them quit smoking. People who are allergic to cytisinicline, have certain medical conditions, or are pregnant cannot join. Women who can become pregnant must use birth control. The study lasts for one year, and participants will be closely monitored to ensure their safety.

• One-year study with cytisinicline treatment.
• Participants will receive support to quit smoking.
• Some medical conditions or pregnancy exclude participation.