This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L (NCT02532374), a na na study. The primary outcome is Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02532374 |
| Phase | NA |
| Condition | Smoking |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Philip Morris Products S.A. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled smoking healthy subjects. The primary pharmacokinetic population is described as subjects with informed consent, at least one P3L product-use period, and at least one derivable pharmacokinetic parameter. The record describes this population as 15 subjects after one withdrawal following the admission-visit product test.
Intervention
Subjects used P3L aerosol at approximate nicotine dose levels of 50 µg/puff, 80 µg/puff, and 150 µg/puff, in that order over Visits 4, 5, and 6. The study aimed to assess nicotine pharmacokinetics, subjective pharmacodynamic effects, safety, and tolerability.
Comparator
Subjects used the Nicorette® inhalator (15 mg) at Visit 3 before using P3L. This was a single-group sequence, not a randomized comparison between separate arms. The registry record therefore does not describe a like-for-like randomized control comparison.
Primary question
The registered primary endpoint is the geometric least-squares mean maximum nicotine concentration (Cmax) after single use of the Nicorette® inhalator. Its stated sampling period extends from pre-use measurements to 240 minutes after T0, the start of product use. The numerical Cmax estimate and its 95% confidence interval are not reported in the registry record.
The broader study purpose was to examine nicotine pharmacokinetic and pharmacodynamic profiles for P3L at three nicotine levels in relation to the Nicorette® inhalator, as well as safety and tolerability. The registry description identifies the product sequence and the endpoint selected as primary, but it does not provide numerical pharmacokinetic or pharmacodynamic results. Consequently, the registered primary question can be described, but its answer cannot be evaluated from the outcome information recorded.
3. Trial Design
This was a completed, single-center, open-label, single-group study. The registry lists an enrollment of 16 and an allocation of NA. Masking is listed as none. The record describes a sequence in which subjects used the Nicorette® inhalator at Visit 3 and then used P3L at increasing nicotine dose levels on later visits. It does not describe separate randomized treatment arms, so the sequence should not be read as a randomized comparison.
The registered description specifies Nicorette® inhalator use at Visit 3, followed by P3L aerosol at approximately 50 µg/puff, 80 µg/puff, and 150 µg/puff on Visits 4, 5, and 6, respectively. The study is described as ascending-dose and open-label. The record does not report whether product-use order could be varied, whether there was a washout interval, or how potential order or period effects were handled. Those design details are not reported in the registry record.
The enrollment period and primary completion are both recorded as 2015-10, and the status is completed. The study phase is listed as NA. Its stated focus was pharmacokinetics, pharmacodynamics (subjective effects), safety, and tolerability in smoking healthy subjects. The registry lists 16 outcome measures, but the primary endpoint information available describes Cmax following single use of the Nicorette® inhalator. Numerical results for that endpoint are not reported in the registry record.
A within-subject sequence can allow measurements from different product-use periods to be considered in relation to the same study participants. In general, however, sequential exposure does not by itself establish that differences between periods are caused by the product or dose. Period, order, carryover, and time-related influences may matter, and the record does not report how they were assessed. The study’s open-label, single-group structure also differs from a blinded randomized parallel-group design, in which independent groups are assigned to treatments under a prespecified allocation procedure.
The registry record does not report a sample-size justification, a detailed statistical analysis plan, or whether any interim analyses were planned or conducted. These items should not be inferred from the study being completed or from the number enrolled.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Enrolled population = 16 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
Overall Study
| Stage | Nicorette® Inhalator Then P3L |
|---|---|
| STARTED | 16 |
| Nicorette Inhalator (Visit 3) | 15 |
| P3L 50 μg/Puff (Visit 4) | 15 |
| P3L 80 μg/Puff (Visit 5) | 14 |
| P3L150 μg/Puff (Visit 6) | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Nicorette® Inhalator Then P3L |
|---|---|
| Withdrawal by Subject | 1 |
| Physician Decision | 1 |
Analysis population for the primary outcome, as defined in the registry: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived. =\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived. No subjects were excluded due to major protocol deviations impacting the evaluation of the results. 1 subject withdrew after the product test at the admission visit.
| Characteristic | Unit | Nicorette® Inhalator Then P3L |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 39.8 (SD 13.83) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 8 |
| Daily CC consumption at Screening: 10 to 19 cig/day | Participants | 9 |
| Daily CC consumption at Screening: > 19 cig/day | Participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator, measured over Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0..
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | ng/mL |
| Endpoint classification | Continuous Endpoint |
The registered primary endpoint is maximum concentration (Cmax) of nicotine following single use of the Nicorette® inhalator. Cmax is a pharmacokinetic measure: it describes the highest measured or derived concentration in blood over the sampling period. It is used to characterize the concentration profile after product use, alongside other possible measures of exposure or timing. As a concentration endpoint, it does not by itself describe subjective effects, safety, or the full time course of nicotine exposure.
The registry specifies a geometric least-squares mean and a 95% confidence interval for this endpoint. A geometric mean is commonly used for measurements whose distribution is better represented on a logarithmic scale than on an untransformed scale. A least-squares mean is a model-based mean; the model and adjustment details for this analysis are not reported in the registry record. A confidence interval communicates uncertainty around an estimate under the analysis assumptions. It is not a range containing a known proportion of individual participants’ values.
Blood sampling is specified at 45, 30, and 15 minutes before T0, and at 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0. The record defines T0 as the start of product use and states that the endpoint is derived from multiple pre-use and post-use samples over 240 minutes after product use. The numerical endpoint estimate and its confidence interval are not reported in the registry record, so the magnitude and precision of the primary endpoint cannot be assessed from the registry information available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary endpoint and describes its measurement schedule, but it does not report a Cmax estimate or confidence interval. It also does not provide a primary-endpoint hypothesis test, p-value, or numerical comparison. Accordingly, the posted information does not establish the size or precision of the primary endpoint result. A protocol description and endpoint definition are not substitutes for an outcome estimate.
The endpoint is specifically Cmax after single use of the Nicorette® inhalator. Although the study’s overall purpose includes evaluation of P3L at three nicotine levels in relation to the inhalator, the primary endpoint information recorded is not a reported head-to-head effect estimate for P3L versus Nicorette®. No numerical P3L-versus-inhalator contrast, uncertainty interval, or adjusted comparison is reported in the registry record. The sequence of use alone should not be interpreted as evidence that any observed difference is attributable to dose or product.
The registry describes a PK population of 15 subjects, following the withdrawal of one subject after the admission-visit product test. This population definition is tied to consent, completion of at least one P3L use period, and availability of at least one derivable PK parameter. It is not necessarily identical to every population used for every endpoint; endpoint-specific analysis populations are not reported in the registry record.
In general, estimates should be read together with their uncertainty intervals and the analysis population used to obtain them. A point estimate alone gives no direct indication of precision. A confidence interval expresses uncertainty under the statistical model and data assumptions; it does not account automatically for every possible source of bias, such as unreported missingness or design limitations. Because the primary estimate and interval are absent, these considerations cannot be applied to a numerical Cmax result.
The study is single-group, open-label, and sequential. This makes it important to distinguish descriptive measurements from causal comparisons. In general, repeated measures from the same participant may be correlated, and measurements in later periods may be affected by sequence or time. The registry record does not report the model used to account for these features. It also does not report a statistical plan sufficient to determine how the investigators intended to handle them.
The safety record lists serious adverse event counts of zero during each named period. These are period-specific counts and do not provide evidence about unreported outcomes or establish the absence of risk. Other adverse event counts are also listed by period, but the record does not provide event-level detail in the registry record recorded. Death counts are not reported. A safety count should be interpreted in light of the period-specific participants at risk and the way events were collected; the available record does not describe further collection or adjudication procedures.
The registry includes no analysis entries. Thus, beyond the endpoint definition and descriptive safety counts, no statistical test results or model-based results are available in this record. Any conclusion about the magnitude, precision, or statistical significance of treatment-related differences would go beyond the reported information.
9. Statistical Methods Explained
What does Cmax represent?
Cmax is the maximum concentration of a measured substance over a specified observation period. For nicotine, the registered endpoint uses blood samples collected before and after product use. The sampling schedule defines when concentrations could be observed, while the endpoint definition identifies which summary of those measurements is of interest. Cmax is one aspect of a concentration-time profile. It does not, on its own, describe total exposure, the time at which the maximum occurs, subjective effects, or safety.
In general, observed sampling times may not coincide exactly with the true biological peak. The value of Cmax therefore depends on the sampling schedule and the method used to derive the endpoint. The registry record states that Cmax was derived from multiple samples over 240 minutes after product use, but it does not report the derivation algorithm or how concentrations between sampling times were treated.
What does a geometric least-squares mean convey?
The primary endpoint is described as a geometric least-squares mean. In general, a geometric mean is calculated on a logarithmic scale and then expressed back on the original scale. It is often used when measurements are positive and their distribution is skewed, though the suitability of that approach depends on the data. A least-squares mean is an estimated mean from a statistical model rather than necessarily the raw arithmetic average of observed values.
The registry does not report the model specification, covariates, transformations in detail, or any adjustment factors used to obtain the least-squares mean. It is therefore possible to explain the meaning of the stated summary measure in general, but not to reconstruct or verify the particular model-based estimate from the registry record.
How should a confidence interval be read?
The endpoint’s stated dispersion measure is a 95% confidence interval. In general, a confidence interval gives a range of values compatible with the observed data under a specified statistical procedure and its assumptions. A narrower interval indicates greater precision than a wider interval on the same scale, but width alone does not establish clinical importance. The interval does not describe the range of individual responses, and it is not a guarantee that the true value lies within the particular interval.
The registry record does not provide the interval’s bounds. Without those bounds, readers cannot assess the estimate’s precision or compare the interval with any clinically relevant threshold. No such threshold is reported in the registry record.
What is the role of the sequential design?
The study description gives the same sequence for product use: Nicorette® inhalator first, followed by ascending P3L nicotine levels. In general, measurements collected from the same participant across periods are related rather than independent. Statistical analysis of repeated measurements may need to account for within-participant correlation. Sequential designs can also be sensitive to period effects, order effects, and carryover from an earlier exposure. These are general design considerations, not findings about this trial.
The registry record does not report whether a washout period was used, how long it lasted, or whether the analysis adjusted for period or sequence. It also does not state whether each endpoint was analyzed using a repeated-measures model or another method. The open-label designation means masking is listed as none; the record does not describe any procedure that would remove awareness of the product being used.
Why do distributions and over-dispersion matter?
In general, the choice of statistical method should reflect the type and distribution of the outcome. Concentration measurements may be skewed, which can motivate transformation or geometric summaries. Counts of events may be more variable than a simple probability model assumes; this is called over-dispersion. When it occurs, standard errors from an overly restrictive model can be too small, making uncertainty appear less than it is. These are general statistical concepts. The registry record does not report a model for event counts or enough detail to assess whether over-dispersion was considered.
For a continuous endpoint, useful reporting commonly includes the analysis population, the estimate, its uncertainty interval, and a clear account of the model. For a comparison, the contrast and its uncertainty are also important. Here, the primary endpoint definition identifies the measure and interval type, but the numerical estimate, interval, and analysis model are not reported in the registry record.
What can be said about planning calculations?
In general, sample-size calculations are planning tools based on assumptions about an effect, variability, significance level, allocation, and analysis method. They do not describe the observed treatment effect and should not be called observed power. The record characterizes a sample-size illustration as a planning exercise based on a stated fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also distinguishes the reporting of participants per arm from total events for time-to-event calculations.
Those assumptions do not establish the rationale for this trial’s enrollment, and the registry record does not report the trial’s own sample-size justification. The registry entries do not give numerical planning outputs to interpret. Since this study is described as a single-group sequence, an equal-allocation two-arm planning assumption should not be confused with the actual trial design.
More generally, statistical significance and practical importance are different questions. A p-value, if reported, would not measure the size of an effect or the probability that a hypothesis is true. An estimate and its interval, together with the design and analysis details, are needed to understand the data. No p-value or numerical primary endpoint estimate is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures, while no analysis entries are listed. It does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment for testing several outcomes. When many outcomes or contrasts are examined, the chance of at least one apparently unusual result can increase. In general, a multiplicity plan clarifies which outcomes are confirmatory and how interpretation should account for multiple testing. Without a reported plan or analysis results, the confirmatory status of other endpoints and the handling of multiple comparisons are not reported in the registry record.
The primary pharmacokinetic population is described as subjects who signed informed consent, completed at least one P3L product-use period, and had at least one derivable PK parameter. The record states that this population comprised 15 subjects and that one subject withdrew after the product test at the admission visit. The registry does not describe endpoint-by-endpoint analysis populations or explain how the withdrawal affected each outcome.
Missing-data procedures are not reported in the registry record. In general, missing measurements can affect an estimate when the likelihood of missingness is related to participant characteristics or outcomes. Analysis choices such as excluding incomplete observations, imputing values, or using models that accommodate incomplete repeated measurements rely on assumptions. The record does not specify which, if any, of these approaches were used, and no assumptions about the reason for missingness should be inferred.
The registry also does not report a detailed statistical analysis plan, interim analyses, or the handling of deviations from the planned sequence. These omissions limit assessment of how analysis decisions were specified and applied. They do not establish that any particular method was or was not used outside the information recorded in the registry.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Enrolment Period | 0 | 16 | 0.0% |
| Nicorette® Inhalator Period | 0 | 15 | 0.0% |
| P3L 50 µg/Puff Period | 0 | 15 | 0.0% |
| P3L 80 µg/Puff Period | 0 | 14 | 0.0% |
| P3L 150 µg/Puff Period | 0 | 14 | 0.0% |
| Safety Follow-up Period | 0 | 16 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Enrolment Period | 7 of 16 |
| Nicorette® Inhalator Period | 3 of 15 |
| P3L 50 µg/Puff Period | 4 of 15 |
| P3L 80 µg/Puff Period | 4 of 14 |
| P3L 150 µg/Puff Period | 8 of 14 |
| Safety Follow-up Period | 2 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Enrolment Period | Nicorette® Inhalator Period | P3L 50 µg/Puff Period | P3L 80 µg/Puff Period | P3L 150 µg/Puff Period | Safety Follow-up Period |
|---|---|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | 0 of 16 | 1 of 15 | 3 of 15 | 3 of 14 | 4 of 14 | 0 of 16 |
| Blood Albumin Decreased | Investigations | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 4 of 14 | 0 of 16 |
| Blood Triglycerides Increased | Investigations | 2 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 1 of 14 | 1 of 16 |
| Blood Glucose Decreased | Investigations | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 2 of 14 | 0 of 16 |
| Blood Glucose Increased | Investigations | 2 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 0 of 14 | 0 of 16 |
| Headache | Nervous system disorders | 0 of 16 | 2 of 15 | 0 of 15 | 0 of 14 | 0 of 14 | 0 of 16 |
| Nausea | Gastrointestinal disorders | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 1 of 14 | 1 of 16 |
| Hot Flush | Vascular disorders | 0 of 16 | 0 of 15 | 0 of 15 | 1 of 14 | 1 of 14 | 0 of 16 |
| Blood Bilirubin Increased | Investigations | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 1 of 14 | 0 of 16 |
| Blood Cholesterol Increased | Investigations | 1 of 16 | 0 of 15 | 0 of 15 | 0 of 14 | 0 of 14 | 0 of 16 |
The registry reports zero participants with serious adverse events in each listed period: enrolment, Nicorette® inhalator, P3L 50 µg/puff, P3L 80 µg/puff, P3L 150 µg/puff, and safety follow-up. The numbers at risk are listed separately for each period: 16 during enrolment, 15 during the Nicorette® period, 15 during the P3L 50 µg/puff period, 14 during the P3L 80 µg/puff period, 14 during the P3L 150 µg/puff period, and 16 during safety follow-up. These period-specific figures should not be added together: the same participant may contribute to more than one period.
Other adverse events are reported by period as affected-participant counts: 7 during enrolment, 3 during the Nicorette® period, 4 during the P3L 50 µg/puff period, 4 during the P3L 80 µg/puff period, 8 during the P3L 150 µg/puff period, and 2 during safety follow-up. The record does not provide event-level descriptions in the information recorded here, so these counts do not indicate the nature, severity, duration, or relationship of those events to product use.
Death counts are not reported in the registry record. No serious-event terms are listed. Zero reported serious adverse events in these periods should be read as the recorded counts, not as proof that serious events were impossible or that all safety outcomes are known.
12. What the Result Does, and Does Not, Mean
The registry record describes a study intended to evaluate pharmacokinetic and pharmacodynamic profiles, safety, and tolerability for P3L at three nicotine levels in relation to the Nicorette® inhalator. It identifies the primary endpoint as Cmax after single use of the inhalator and specifies a geometric least-squares mean with a 95% confidence interval. It also records the product-use sequence and period-specific adverse event counts.
The record does not report a numerical Cmax estimate, confidence interval bounds, or a statistical test result. It therefore does not support a quantitative statement about the primary endpoint’s magnitude or precision. Nor does the available information provide a numerical comparison of P3L doses with the inhalator. A study objective is not an outcome, and the existence of a planned endpoint does not reveal its observed value.
The design is a single-group, open-label sequence rather than a randomized comparison between separate groups. In general, measurements from successive product-use periods can be influenced by timing, order, or carryover. The registry does not report how these factors were addressed. Consequently, even if descriptive values were available, a causal interpretation would require design and analysis details beyond those recorded.
The safety counts show the numbers recorded as affected during specific periods, including zero serious adverse events in each period. They do not describe the event types or establish the absence of risk. Death counts are not reported in the registry record. The period-specific nature of the counts also means they should not be combined into a cumulative total.
These data should not be interpreted as medical advice or as establishing that a product is beneficial or harmful. The statistical record supports description of the study’s design, endpoint definition, and recorded counts, while leaving the primary numerical results and important analytic details unreported.
13. Why This Trial Matters Statistically
This study illustrates why a clearly named endpoint and an available numerical result are both necessary for statistical interpretation. The registry identifies Cmax, its measurement schedule, and the intended summary as a geometric least-squares mean with a 95% confidence interval. Yet without the estimate and interval bounds, readers cannot judge the magnitude or precision of the primary result. Endpoint definitions explain what investigators intended to measure; they do not communicate what the measurements showed.
The study also highlights the distinction between a sequence of exposures and a randomized comparison. The described progression from Nicorette® inhalator to ascending P3L nicotine levels provides a structure for collecting measurements across product-use periods, but it does not create separate randomized arms. General concerns about within-participant correlation, period effects, and carryover depend on design and analytic details that the registry does not report.
Safety reporting likewise needs context. The record gives period-specific numbers at risk and affected, including the serious adverse event counts, but does not list the nature of other events or report death counts. Keeping period counts separate avoids treating repeated observations across periods as independent people or combining them into a total that the record does not provide.
Finally, the registry lists multiple outcome measures but does not report an analysis plan or analysis entries. This makes it difficult to distinguish confirmatory findings from exploratory analyses or to assess how uncertainty and multiplicity were handled. The example demonstrates a general principle: transparent reporting of estimates, uncertainty, populations, and methods is needed to move from a trial description to a sound statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting results is that the registry record does not report the numerical Cmax estimate or its 95% confidence interval. It also does not report a p-value or a numerical contrast for P3L versus the Nicorette® inhalator. The study’s stated objective includes pharmacokinetic and pharmacodynamic evaluation of P3L, but the recorded primary endpoint is specifically Cmax after single use of the inhalator.
The design is listed as single-group, open-label, and sequential. There is no randomized allocation between separate arms. The record does not report how period effects, order, carryover, or within-participant correlation were handled, nor does it describe washout procedures. Those missing details limit evaluation of any comparison across product-use periods.
The endpoint description reports a geometric least-squares mean and confidence interval but does not identify the model, transformations in detail, covariates, or other adjustment choices. The registry lists 16 outcome measures but no analysis entries and no multiplicity procedure. The statistical analysis plan and interim-analysis information are not reported in the registry record.
The record identifies one withdrawal after the admission-visit product test and describes a PK population of 15 subjects. It does not report endpoint-specific populations or missing-data procedures. Safety information is limited to period-specific counts; event descriptions and death counts are not reported. These limitations concern what can be assessed from the registry record and should not be treated as evidence about analyses or events that may have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L — NCT02532374.
- Registry record last updated 2020-02-24; status last verified 2020-02.
- Results first posted 2017-06-15.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02532374 is a completed, single-center, open-label, single-group study of P3L and the Nicorette® inhalator in smoking healthy subjects. Enrollment is listed as 16. Subjects used the Nicorette® inhalator at Visit 3, followed by P3L aerosol at approximate nicotine levels of 50 µg/puff, 80 µg/puff, and 150 µg/puff on Visits 4, 5, and 6.
The primary endpoint is maximum nicotine concentration after single use of the Nicorette® inhalator, summarized as a geometric least-squares mean with a 95% confidence interval. The registry describes a PK population of 15 subjects after one withdrawal following the admission-visit product test. Numerical primary endpoint results, the analysis model, missing-data methods, multiplicity handling, and death counts are not reported in the registry record. Serious adverse event counts are recorded as zero for each listed period.