NFL Biosciences SA is officially launching its CESTO II Phase II/III clinical trial to assess the efficacy and safety of its NFL-101 smoking cessation treatment. Approved by the Human Research Ethics Committee (HREC) in Australia and by the French National Agency for the Safety of Medicines and Health Products (ANSM), CESTO II will include its first patients beginning January 2022 at the four clinical centers opened. The CESTO II Phase 2/3 clinical trial will be multicentric, randomized, double blind and placebo controlled. The trial is being conducted as follows: three arms (two dose arms and one placebo arm); 318 smokers aged 18 and over; Monitoring of patients over 12 months (CESTO2, NCT04571216); The subjects will receive two initial subcutaneous injections one week apart. Additional follow-up injections could be provided after three and six months for patients who have not stopped smoking by these dates; The opened centers are the University of Tasmania’s clinical center in Australia, and the Clinical Investigation Centers (CIC) in Poitiers, Bordeaux and Rennes in France. This study’s primary objectives are to select the best dose and assess the efficacy of NFL-101 versus placebo, for both immediate and gradual smoking cessation. The criteria for assessment are the subject’s continued abstinence for four weeks (FDA) and six months (EMA). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. A range of secondary criteria will also be assessed, including the number of cigarettes smoked, withdrawal symptoms and level of craving.