CITISILONG

9 evidence topics · 2 sources

Objective

Duration-comparison objective

“efficacy and safety” (opens the source at this quote in a new tab)

Location and study date

Planned centers and country

“A total of 402 patients from 10 smoking cessation units in Spain will be randomized.” (opens the source at this quote in a new tab)

Study design

Trial masking

“open-label” (opens the source at this quote in a new tab)

Eligibility criteria

Adult eligibility threshold

Characteristic	Quoted value
Minimum age, years	“18”

Treatment

Planned cytisine durations

Characteristic	Quoted value
Standard course, days	“25”
Extended course, days	“50”
Longest course, days	“75”

Study outcomes

Rationale for using continuous smoking abstinence as the primary endpoint

Long-term abstinence assessments

“6 and 12 months” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned statistical design

Characteristic	Quoted value
Target participants	“402”
Power	“80%”
Anticipated losses	“21%”

Description of analysis sets

Planned analysis set

“clinically evaluable population” (opens the source at this quote in a new tab)

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

The report contains a protocol, not observed cessation or safety results. Planned comparisons are open-label and use 25-, 50-, and 75-day courses. The clinically evaluable analysis population may differ from all randomized participants.