Biomarkers of Exposure and Biomarkers of Potential Harm i... | NCT04800211 | Trialant
NCT04800211
Sponsor
Altria Client Services LLC
Status
Completed
Last Update Posted
Mar 12, 2025Actual
Enrollment
450Actual
Phase
Not Applicable
Conditions
Tobacco Use
Interventions
Experimental: Test Product 1
Experimental: Test Product 2
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04800211
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ALCS-RA-16-06/ALCS-RA-17-11-EV
Secondary IDs
Not provided
Brief Title
Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products
Official Title
An Open-Label, Parallel-Group, Controlled Study to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to Using e-Vapor Products for 24 Weeks
Acronym
Not provided
Organization
Altria Client Services LLCINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 17, 2017Actual
Primary Completion Date
Jul 20, 2018Actual
Completion Date
Nov 6, 2018Actual
First Submitted Date
Mar 11, 2021
First Submission Date that Met QC Criteria
Mar 15, 2021
First Posted Date
Mar 16, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 4, 2024
Results First Submitted that Met QC Criteria
Feb 20, 2025
Results First Posted Date
Mar 12, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 20, 2025
Last Update Posted Date
Mar 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Altria Client Services LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an e-vapor product (EVP) relative to adult smokers who continue smoking exclusively.
Detailed Description
This study was conducted as a randomized, parallel-group, open-label, 24-week, controlled clinical study split into an initial 12-week study (Study 1), with a follow-up at 24 weeks (Study 2) in a sub-population of switchers. For Study 1 a total of 450 subjects were enrolled. Of those subjects who successfully completed Study 1, 150 were then enrolled into Study 2 with no interruption in study participation. The study compared changes in BoE and BoPH in AS who switched to ad libitum use of one of two test EVPs with those in the Control group who continued to smoke conventional cigarettes. The study enrolled AS who were considered to be in overall good health.
Conditions Module
Conditions
Tobacco Use
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
450Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Control
No Intervention
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Test 1
Experimental
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Other: Experimental: Test Product 1
Test 2
Experimental
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Other: Experimental: Test Product 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Experimental: Test Product 1
Other
Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Test 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Urine Total NNAL (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Secondary Outcomes
Measure
Description
Time Frame
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Participant compliance for the abstention of any type of tobacco/nicotine product for the duration of the study was assessed by measuring the participant's exhaled carbon monoxide (eCO, ppm). According to their eCO measurements at Weeks 12 (study ALCS-RA-16-06-EV) and Week 24 (study ALCS-RA-17-11-EV), participants were categorized into 1 of 3 categories: 'eCO ≤ 5', 'eCO < 5 - ≤ 8', or 'eCO > 8'. Lower eCO values represent lower smoking exposure and increased compliance, with the 'eCO ≤ 5' category indicating that the participant abstained from smoking, the 'eCO < 5 - ≤ 8' category indicating low smoking exposure to the participant, and the 'eCO > 8' category indicating non-compliance with the study criteria that the participant refrain from smoking during the study.
Other Outcomes
Measure
Description
Time Frame
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine Nicotine Equivalents (mg/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
The first urine void of the day was collected at Visits 3, 5 and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Study 1
Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
sign an IRB-approved informed consent form (ICF) for the study;
be between the ages of 30 and 65 years, inclusive, at the time of Screening, Visit 1;
have > 500 ng/ml urine cotinine measurement at Screening, Visit 1;
have smoked for ≥ 10 years and smoked an average of ≥ 10 manufactured cigarettes per day during the 12 months prior to Screening, Visit 1;
a) Brief periods [i.e., up to 7 consecutive days] of non smoking during the 12 months prior to Screening, Visit 1 due to illness, trying to quit, or participation in a study where smoking was prohibited are acceptable.
indicate that he/she is "definitely" or "probably" willing and able to replace their cigarettes for 12 weeks with the assigned test e-Vapor product;
have daily access to text messaging capable cellular phone for daily product use reporting;
have a negative ethanol breath test and amphetamines, opiates, cannabinoids, and cocaine urine drug screen results at Screening, Visit 1;
a) Subjects with a prescription from a licensed physician will not be exempted from this criterion.
if female (all females), have a negative serum pregnancy test at Visit 1 and negative urine pregnancy test at Visit 2 through Visit 7, inclusive;
if female, heterosexually active, and of childbearing potential (i.e., not surgically sterile or 2 years naturally postmenopausal), must have used a medically accepted method of contraception (listed below in a) and b)) prior to Screening, Visit 1 and must agree to continue to use such method(s) through the End of Study;
Surgically sterile includes bilateral tubal ligation, Essure, hysterectomy, or bilateral oophorectomy at least 6 months prior to Screening, Visit 1. Naturally postmenopausal is defined as women having 2 years without menses.
Acceptable methods of contraception are: hormonal (i.e., oral, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening, Visit 1; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Screening, Visit 1; and intrauterine device for at least 3 months prior to Screening, Visit 1; or only have a partner who has been vasectomized for at least 6 months prior to Screening, Visit 1.
Be willing and able to comply with the requirements of the study.
Study 2
Subjects must satisfy the following criteria before being enrolled into the study. Subject must:
have participated in and completed the 12-week ALCS-RA-16-06-EV study and have Baseline biomarker samples collected;
demonstrate willingness to participate by signing an Institutional Review Board (IRB)-approved ICF for the study;
have demonstrated consistent daily reporting of product use in the 12-week ALCS-RA-16-06-EV (≥ 80% reporting compliance);
if randomized to a Test group, have reported an average of no more than 10% of Baseline cigarette smoking per day through Week 11 of the 12-week ALCS-RA-16-06-EV study;
if randomized to a Test group, have reported use of at least two Test product cartridges per week in the 12-week ALCS-RA-16-06-EV study;
if randomized to a Test group, have exhaled carbon monoxide (eCO) measurements of ≤ 8 ppm at each post-Baseline time point in the 12-week ALCS-RA-16-06-EV study;
have daily access to text messaging capable cellular phone for daily product use reporting;
if female (all females), have a negative urine pregnancy test at Week 12 (Visit 1) through Week 24 (Visit 5), inclusive;
if female, heterosexually active, and of childbearing potential (i.e., not surgically sterile or 2 years naturally postmenopausal), must have used a medically accepted method of contraception (listed below in a) and b)) prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study and must agree to continue to use such method(s) through Week 24 (EOS);
Surgically sterile includes bilateral tubal ligation, Essure, hysterectomy, or bilateral oophorectomy at least 6 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study. Naturally postmenopausal is defined as women having 2 years without menses.
Acceptable methods of contraception are: hormonal (i.e., oral, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; and intrauterine device for at least 3 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study; or only have a partner who has been vasectomized for at least 6 months prior to Screening, Visit 1 of the 12-week ALCS-RA-16-06-EV study.
Be willing and able to comply with the requirements of the study.
Exclusion Criteria:
Study 1
Subjects may be excluded from the study if there is evidence of any of the following criteria. Exceptions may be permitted at the discretion of the Investigator and in consultation with the Sponsor or designee provided there would be no additional risk to the subject. Any exceptions will be documented.
History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes, existing respiratory diseases, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. (Note: chronic medical conditions controlled and on stable medications [over past 3 months] may not necessarily be exclusionary per Investigator discretion);
Currently taking medication for depression, asthma or diabetes;
Allergy to menthol;
Systolic blood pressure > 140 mmHg and / or diastolic blood pressure > 90 mmHg at Screening Visit 1.
Have clinically significant abnormal findings on the physical examination, vital signs, electrocardiogram (ECG), or medical history that would jeopardize the safety of the subject, in the opinion of the Investigator;
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) at Screening, Visit 1;
Current evidence or any history of congestive heart failure;
Any acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks before Visit 3 (Day 1);
History of drug or alcohol abuse within 24 months of Visit 3 (Day 1) as defined by the Investigator;
BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening, Visit 1;
Post-bronchodilator Forced expiratory volume at one second (FEV1):Forced vital capacity (FVC) ratio < 0.7 and FEV1 < 50% of predicted at Screening, Visit 2;
Post-bronchodilator FEV1:FVC ratio < 0.75 and FEV1 increase ≥ 12% and > 200 mL from pre- to post-bronchodilator at Screening, Visit 2;
Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.5 times the upper limit of the reference range at Screening, Visit 1;
Female candidates who are pregnant, lactating, or intend to become pregnant from Screening, Visit 1 through End of Study;
Use of HDL-C raising medication / supplements (e.g., niacin, gemfibrizole, fenofibrate, etc.) within the past 3 months prior to Screening, Visit 1 or any time during the study;
Use of nicotine-containing products other than manufactured cigarettes (e.g., roll-your-own cigarettes, e-cigarette or e-Vapor products, Bidis, snuff, nicotine inhaler, pipe, cigar, smokeless tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Screening, Visit 1 through Visit 3 (Day 1) except as required for the purpose of this study;
Donation of blood or blood products, including plasma, history of significant blood loss in the opinion of the investigator, or receipt of whole blood or a blood product transfusion within 60 days prior to Visit 3 (Day 1);
Participation in a clinical study of an investigational drug, medical device, biologic, or of a tobacco product, within 30 days before Visit 3 (Day 1);
Participation in more than two ALCS studies within 12 months before Visit 3 (Day 1);
Already enrolled or failed screening for the current study at a different study site;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company.
Study 2
Subjects may be excluded from the study if there is evidence of any of the following. Exceptions may be permitted at the discretion of the Investigator and in consultation with the Sponsor or designee provided there would be no additional risk to the subject. Any exceptions will be documented.
Have clinically significant abnormal findings on the physical examination, vital signs, or ECG at the EOS visit (Visit 7) of the 12-week ALCS-RA-16-06-EV study that would jeopardize the safety of the subject, in the opinion of the Investigator;
Female subjects who are pregnant (as determined at the EOS visit [Visit 7] of the 12-week study), lactating, or intend to become pregnant from Visit 1 (Week 12) through Week 24 (EOS);
Use of any medication for depression, asthma, or diabetes at any time during the study;
Use of HDL-C raising medication / supplements (e.g., niacin, gemfibrozil, fenofibrate, etc.) at any time during the study;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company;
Subject or a first-degree relative (i.e., parent, spouse, sibling, or child) is a current or former employee of Celerion or any of the clinical study sites.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
30 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jeffery Edmiston, PhD
Altria Client Services
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
LA Clinical Trials
Burbank
California
91505
United States
Heartland Research Associates, LLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
After screening, subjects who met all eligibility criteria were randomized to one of the study groups. Eligible subjects who completed ALCS-RA-16-06-EV were entered into the ALCS-RA-17-11-EV 12-week extension study and assigned to the same study groups as the ALCS-RA-16-06-EV study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Periods
Title
Milestones
Reasons Not Completed
ALCS-RA-16-06-EV (Weeks 1-12)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: ALCS-RA-16-06-EV Protocol Version 1
Nov 10, 2016
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This research study utilized a parallel-group, open-label, controlled design and was conducted at multiple study sites.
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental: Test Product 2
Other
Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Test 2
Summary of whole blood carboxyhemoglobin (COHb) (% Saturation) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood COHb (% Saturation) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of whole blood white blood cell (WBC) count (10^3 cells/uL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood WBC Count (10^3 cells/uL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of serum high density lipoprotein cholesterol (HDL-C) (mg/dL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of serum HDL-C (mg/dL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of plasma soluble Intercellular Adhesion Molecule-1 (sICAM-1) (ng/mL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of plasma sICAM-1 (ng/mL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Summary of Whole Blood WBC Absolute Change From Baseline (10^3 Cells/uL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood WBC absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Serum HDL-C Absolute Change From Baseline (mg/dL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of serum HDL-C absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine 8-epi-prostaglandin F2alpha Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine 11-dehydrothromboxane B2 Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Plasma sICAM-1 Absolute Change From Baseline (ng/mL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of plasma sICAM-1 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Urine Total NNAL Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine total NNAL absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Summary of Whole Blood COHB Absolute Change From Baseline (% Saturation) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood COHB absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
Weeks 12 (Study ALCS-RA-16-06-EV) and Week 24 (Study ALCS-RA-17-11-EV) from randomization
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced expiratory volume in the first second (FEV1) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FEV1 = Forced Expiratory Volume in 1 Second
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced vital capacity (FVC) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FVC = Forced Vital Capacity
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted FEV1/FVC and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine nicotine equivalents (mg/g Cr) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Absolute change from baseline = Post Product Use Value - Baseline Val
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
Wichita
Kansas
67207
United States
Central Kentucky Research Associates
Lexington
Kentucky
40509
United States
DaVita Clinical Research
Minneapolis
Minnesota
55404
United States
QPS Bio-Kinetic
Springfield
Missouri
65802
United States
Celerion
Lincoln
Nebraska
68502
United States
Clinical Research Consortium
Las Vegas
Nevada
89119
United States
High Point Clinical Trials Center
High Point
North Carolina
27265
United States
Rose Research Center, LLC
Raleigh
North Carolina
27617
United States
New Orleans Center for Clinical Research
Knoxville
Tennessee
37920
United States
FG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
FG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
FG000151 subjects
FG001150 subjects
FG002149 subjects
COMPLETED
FG000121 subjects
FG001125 subjects
FG002136 subjects
NOT COMPLETED
FG00030 subjects
FG00125 subjects
FG00213 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0011 subjects
FG0020 subjects
Failure To Meet Ie Post Enrollment
FG0001 subjects
FG0010 subjects
FG0020 subjects
Lost to Follow-up
FG0008 subjects
FG0018 subjects
FG0022 subjects
Non-Compliance With Study Procedures
FG0008 subjects
FG0017 subjects
FG0022 subjects
Other
FG0001 subjects
FG0012 subjects
FG0022 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG0008 subjects
FG0017 subjects
FG0025 subjects
ALCS-RA-17-11-EV (Weeks 12-24)
Type
Comment
Milestone Data
STARTED
FG00048 subjects
FG00150 subjects
FG00252 subjects
COMPLETED
FG00047 subjects
FG00150 subjects
FG00249 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0023 subjects
Type
Comment
Reasons
Non-Compliance With Study Procedures
FG0000 subjects
FG0010 subjects
FG0021 subjects
Other
FG000
Clinical Safety Population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
BG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
BG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000151
BG001150
BG002149
BG003450
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.9± 8.45
BG00144.1± 9.26
BG00244.4± 10.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00074
BG00175
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0018
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
BG002
Annual Income
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
I DO NOT WISH TO ANSWER
BG00013
BG00117
BG002
Highest Degree
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
I DO NOT WISH TO ANSWER
BG0000
BG0011
BG002
Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00082.0± 17.43
BG00182.2± 17.63
BG002
Body Mass Index
Mean
Standard Deviation
(kg/m²)
Title
Denominators
Categories
Title
Measurements
BG00027.810± 5.1312
BG00127.915± 5.1466
BG002
Daily Cigarette Use
Data was collected from subject responses at screening reporting the number of cigarettes smoked per day (CPD).
Mean
Standard Deviation
Cigarettes per day
Title
Denominators
Categories
Title
Measurements
BG00018.2± 5.71
BG00117.0± 5.23
Years Smoked
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00024.1± 8.32
BG00125.0± 9.48
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000171.51± 9.402
BG001171.40± 9.682
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Modified Intention-to-Treat (mITT): All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001131
OG002258
OG003
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001131
ParticipantsOG002258
ParticipantsOG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-178.789
2-Sided
95
-204.899
-152.678
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Primary
Summary of Urine Total NNAL and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Urine Total NNAL (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of whole blood carboxyhemoglobin (COHb) (% Saturation) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
percent saturation
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Primary
Summary of Whole Blood COHb and Absolute Change From Baseline (% Saturation) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood COHb (% Saturation) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
percent saturation
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of whole blood white blood cell (WBC) count (10^3 cells/uL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
10^3 cells/uL
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Primary
Summary of Whole Blood WBC Count and Absolute Change From Baseline (10^3 Cells/uL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of Whole Blood WBC Count (10^3 cells/uL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
10^3 cells/uL
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of serum high density lipoprotein cholesterol (HDL-C) (mg/dL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
mg/dL
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Primary
Summary of Serum HDL-C and Absolute Change From Baseline (mg/dL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of serum HDL-C (mg/dL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
mg/dL
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 8-epi-prostaglandin F2alpha and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 8-epi-prostaglandin F2alpha (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
The first urine void of the day was collected at Visits 3, 5 and 7.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 11-dehydrothromboxane B2 and Absolute Change From Baseline (ng/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine 11-dehydrothromboxane B2 (ng/g) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/g
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of plasma soluble Intercellular Adhesion Molecule-1 (sICAM-1) (ng/mL) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3, 5, and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/mL
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Primary
Summary of Plasma sICAM-1 and Absolute Change From Baseline (ng/mL) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of plasma sICAM-1 (ng/mL) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
Blood samples were collected via direct venipuncture on Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Change from Baseline was calculated as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value, where Baseline = values reported on Day 1 (Week 1) of the 12-week ALCS-RA-16-06-EV study
Baseline = Day 1 (Week 1), Visit 1 = Week 12 (Day 84 ± 3), Visit 3 = Week 18 (Day 126 ± 3), and Visit 5 = Week 24 (Day 168 ± 3), relative to the start of the 12-week ALCS-RA-16-06-EV study
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
ng/mL
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Whole Blood WBC Absolute Change From Baseline (10^3 Cells/uL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood WBC absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
10^3 cells/uL
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Serum HDL-C Absolute Change From Baseline (mg/dL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of serum HDL-C absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
mg/dL
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 8-epi-prostaglandin F2alpha Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 8-epi-prostaglandin F2alpha absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
ng/g
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine 11-dehydrothromboxane B2 Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine 11-dehydrothromboxane B2 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
ng/g
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Plasma sICAM-1 Absolute Change From Baseline (ng/mL) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of plasma sICAM-1 absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
ng/mL
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Urine Total NNAL Absolute Change From Baseline (ng/g) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of urine total NNAL absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
The first urine void of the day on Visits 3 and 7 was analyzed for the urine biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration value as follows:
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
ng/g
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Primary
Summary of Whole Blood COHB Absolute Change From Baseline (% Saturation) by Study Group From Week 1 to Week 12 (mITT Population With Outliers Excluded) [ALCS-RA-16-06-EV]
Summary of whole blood COHB absolute change from Baseline in Week 12 is presented (Study ALCS-RA-16-06-EV).
Blood samples were collected via direct venipuncture at Visits 3 and 7 and analyzed for the biomarker. Data outliers were examined through Proc Mixed model residual diagnosis (+/- 4 studentized residuals). A sensitivity analysis excluding outliers was performed for Visit 7 (Week 12).
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT Population with Outliers Excluded: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker. Data outliers, defined as any observation with a studentized residual that is greater than +/- 4, were excluded from the analysis.
Posted
Mean
Standard Deviation
percent saturation
Week 1 (Baseline) and Week 12 for a total of of 12 weeks from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Secondary
Frequency of eCO as Compliance Indicator, Weeks 12 (Study ALCS-RA-16-06-EV) and 24 (Study ALCS-RA-17-11-EV)
Participant compliance for the abstention of any type of tobacco/nicotine product for the duration of the study was assessed by measuring the participant's exhaled carbon monoxide (eCO, ppm). According to their eCO measurements at Weeks 12 (study ALCS-RA-16-06-EV) and Week 24 (study ALCS-RA-17-11-EV), participants were categorized into 1 of 3 categories: 'eCO ≤ 5', 'eCO < 5 - ≤ 8', or 'eCO > 8'. Lower eCO values represent lower smoking exposure and increased compliance, with the 'eCO ≤ 5' category indicating that the participant abstained from smoking, the 'eCO < 5 - ≤ 8' category indicating low smoking exposure to the participant, and the 'eCO > 8' category indicating non-compliance with the study criteria that the participant refrain from smoking during the study.
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Count of Participants
Participants
Weeks 12 (Study ALCS-RA-16-06-EV) and Week 24 (Study ALCS-RA-17-11-EV) from randomization
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Secondary
Percentage of Predicted FEV1 and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced expiratory volume in the first second (FEV1) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FEV1 = Forced Expiratory Volume in 1 Second
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
percentage of predicted FEV1
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Secondary
Percentage of Predicted FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted forced vital capacity (FVC) and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
FVC = Forced Vital Capacity
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
percentage of predicted FVC
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Secondary
Percentage of Predicted FEV1/FVC and Absolute Change From Baseline to Week 12 by Study Group (mITT Population) [ALCS-RA-16-06-EV]
Percentage of predicted FEV1/FVC and absolute change from Baseline to Week 12 by Study Group is presented (Study ALCS-RA-16-06-EV).
Baseline / Screening = Day -28 to Day -5 Visit 7 (Week 12) = Day 84 ± 3
Absolute change from baseline = Post Product Use Value - Baseline Value
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
percentage of predicted FEV1/FVC
Assessments at Screening (Day -28 to Day -5) and Week 12 (Day 84 +/- 3 )
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Other Pre-specified
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 12 (mITT Population) [ALCS-RA-16-06-EV]
Summary of urine Nicotine Equivalents (mg/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV).
The first urine void of the day was collected at Visits 3, 5 and 7.
Absolute change from baseline = Post Product Use Value - Baseline Value
Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
mg/g
12 weeks total with measurement timepoints at Week 1/Baseline, Week 6 and Week 12
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Other Pre-specified
Summary of Urine Nicotine Equivalents and Absolute Change From Baseline (mg/g) by Study Group and Visit From Week 1 to Week 24 (mITT Population) [ALCS-RA-17-11-EV]
Summary of urine nicotine equivalents (mg/g Cr) and absolute change from Baseline in Weeks 12, 18 and 24 are presented (Study ALCS-RA-17-11-EV).
The first urine void of the day was collected at Visits 1, 3 and 5 of the ALCS-RA-17-11-EV study. Baseline samples were collected Week 1 of the ALCS-RA-16-06-EV study.
Absolute change from baseline = Post Product Use Value - Baseline Val
Modified ITT: All subjects were randomized according to the randomization schedule; who used at least one study products after randomization was recorded and for whom there was a valid (within ±3 days of the planned measurement day) baseline and at least one post-baseline biomarker.
Posted
Mean
Standard Deviation
mg/g
24 weeks total with measurement timepoints at Week 1/Baseline [ALCS-RA-16-06-EV study]), and Week 12, Week 18 and Week 24 [ALCS-RA-17-11-EV study]
ID
Title
Description
OG000
Test 1
Exclusive ad libitum use of test e-Vapor Product NuMark LLC, MarkTen® XL Bold CLASSIC* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 1: Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
Time Frame
Adverse events were monitored and recorded from the time of Screening/Visit 2 of the 12-week ALCS-RA-16-06-EV study until Week 24/ End of Study of the ALCS-RA-17-11-EV extension study (or upon early termination).
Description
After completing screening at Visit 2 of the ALCS-RA-16-06-EV study, eligible subjects were randomized to a study group. Eligible subjects completing ALCS-RA-16-06-EV were enrolled in the ALCS-RA-17-11-EV extension study to the same study group. Adverse events are reported per study (ALCS-RA-16-06-EV or ALCS-RA-17-11-EV).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Test 1 (ALCS-RA-16-06-EV)
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
*Product no longer sold commercially
0
151
1
151
49
151
EG001
Test 2 (ALCS-RA-16-06-EV)
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
*Product no longer sold commercially
0
150
1
150
47
150
EG002
Control (ALCS-RA-16-06-EV)
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-16-06-EV.
0
149
1
149
24
149
EG003
Overall (ALCS-RA-16-06-EV)
This group consists of all subjects who participated in study ALCS-RA-16-06-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
0
450
3
450
120
450
EG004
Test 1 (ALCS-RA-17-11-EV)
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 1 (Nu Mark LLC, MarkTen® XL Bold CLASSIC*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
*Product no longer sold commercially
0
48
0
48
13
48
EG005
Test 2 (ALCS-RA-17-11-EV)
Subjects were instructed to stop use of their own brand of cigarettes and were provided with exclusive ad libitum use of e-vapor Test Product 2 (Nu Mark LLC, MarkTen® XL Bold MENTHOL*) without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
*Product no longer sold commercially
0
50
0
50
15
50
EG006
Control (ALCS-RA-17-11-EV)
Subjects continued smoking their own brand of conventional lit-end cigarettes under ad libitum use of, without use of any other type of tobacco/nicotine containing product, for the entire duration of participation in study ALCS-RA-17-11-EV.
0
52
0
52
10
52
EG007
Overall (ALCS-RA-17-11-EV)
This group consists of all subjects who participated in study ALCS-RA-17-11-EV and were assigned to the Test 1 group, the Test 2 group or the Control group.
0
150
0
150
38
150
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Multiple fractures secondary to motor vehicle accident
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
Subject 5048 had multiple fractures due to a road traffic accident during Week 8 of the study. The subject completed the study. The PI considered the multiple fractures, road traffic accident, and hematoma (on scalp) not related to study product.
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG0031 events1 affected450 at risk
Suicidal Ideation
Psychiatric disorders
MedDRA
Systematic Assessment
Subject 9082 experienced suicidal ideation during Week 8 of study. Subject failed to report his history of treatment for psychiatric condition since age 16. The PI considered suicidal ideation unlikely to be related, or not related, to the product.
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
MISCARRIAGE
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
Subject 6105 was found to be pregnant during Week 12 of the study and was discontinued. On 18 July 2017, the subject reported that she had a spontaneous miscarriage at home the day prior. The PI considered this event not related to study product.
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0021 events1 affected149 at risk
EG0032 events2 affected450 at risk
EG0040 events0 affected48 at risk
EG0050 events0 affected50 at risk
EG0061 events1 affected52 at risk
EG0071 events1 affected150 at risk
Haemoconcentration
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Osteogenesis imperfecta
Congenital, familial and genetic disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Thyroglossal cyst
Congenital, familial and genetic disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dry eye
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Eye irritation
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0013 events3 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0003 events3 affected151 at risk
EG0014 events4 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Gingival recession
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0012 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Feeling jittery
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Abscess jaw
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Furuncle
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Otitis media
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0006 events5 affected151 at risk
EG0018 events3 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0012 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0012 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Fractured coccyx
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0014 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Bilirubin urine present
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Colonoscopy
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Haematocrit increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Urine ketone body present
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Urobilinogen urine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Weight increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Food craving
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0013 events3 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Muscle strain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Intraductal papilloma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Oral papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0006 events5 affected151 at risk
EG0013 events3 affected150 at risk
EG0022 events2 affected149 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0012 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Haemoglobinuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0005 events5 affected151 at risk
EG0017 events7 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0022 events2 affected149 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0003 events3 affected151 at risk
EG0013 events3 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected151 at risk
EG0011 events1 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0010 events0 affected150 at risk
EG0021 events1 affected149 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected151 at risk
EG0010 events0 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected151 at risk
EG0012 events2 affected150 at risk
EG0020 events0 affected149 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Jeffery Edmiston, Functional Director Clinical Research
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-184.391
2-Sided
95
-211.184
-157.598
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-175.100
2-Sided
95
-200.964
-149.237
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-161.576
2-Sided
95
-187.543
-135.609
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-172.983
2-Sided
95
-192.080
-153.886
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.7781
Mean Difference (Net)
-3.585
2-Sided
95
-28.572
21.401
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.5457
Mean Difference (Net)
-7.764
2-Sided
95
-32.993
17.465
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-175.203
2-Sided
95
-220.445
-129.961
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-176.627
2-Sided
95
-222.672
-130.582
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-171.515
2-Sided
95
-216.626
-126.404
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-153.812
2-Sided
95
-199.270
-108.354
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-165.220
2-Sided
95
-195.898
-134.541
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2188
Mean Difference (Net)
-22.815
2-Sided
95
-59.223
13.593
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Title
Measurements
OG000258.644± 190.1771
OG001294.309± 217.0554
OG002277.028± 204.2020
OG003
Visit 1: Week 12
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-248.311
2-Sided
95
-286.423
-210.199
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-247.572
2-Sided
95
-280.904
-214.241
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-245.868
2-Sided
95
-284.945
-206.791
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-234.942
2-Sided
95
-271.603
-198.282
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-244.049
2-Sided
95
-275.269
-212.829
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-221.385
2-Sided
95
-258.371
-184.398
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-233.626
2-Sided
95
-261.113
-206.140
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1672
Mean Difference (Net)
26.266
2-Sided
95
-11.130
63.661
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0140
Mean Difference (Net)
-40.051
2-Sided
95
-71.881
-8.221
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0288
Mean Difference (Net)
-42.635
2-Sided
95
-80.785
-4.484
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-274.577
2-Sided
95
-345.428
-203.726
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-207.521
2-Sided
95
-269.198
-145.844
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-203.233
2-Sided
95
-275.683
-130.784
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-261.208
2-Sided
95
-330.647
-191.769
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-203.998
2-Sided
95
-263.396
-144.599
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-178.750
2-Sided
95
-249.092
-108.408
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-190.992
2-Sided
95
-237.134
-144.850
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3590
Mean Difference (Net)
-24.483
2-Sided
95
-77.096
28.130
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001131
OG002258
OG003138
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001131
ParticipantsOG002258
ParticipantsOG003138
Title
Measurements
OG0005.63± 2.073
OG0015.39± 1.868
OG0025.51± 1.971
OG003
Visit 5: Week 6
ParticipantsOG000124
ParticipantsOG001126
ParticipantsOG002250
ParticipantsOG003135
Visit 7: Week 12
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003128
Change from Baseline (Week 6)
ParticipantsOG000124
ParticipantsOG001126
ParticipantsOG002250
ParticipantsOG003135
Change from Baseline (Week 12)
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003128
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.287
2-Sided
95
-2.582
-1.992
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.415
2-Sided
95
-2.722
-2.107
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.382
2-Sided
95
-2.673
-2.090
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.486
2-Sided
95
-2.782
-2.190
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.450
2-Sided
95
-2.668
-2.233
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0012
Mean Difference (Net)
0.466
2-Sided
95
0.185
0.747
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.4957
Mean Difference (Net)
0.099
2-Sided
95
-0.187
0.386
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.753
2-Sided
95
-3.266
-2.239
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.514
2-Sided
95
-3.043
-1.986
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.848
2-Sided
95
-3.359
-2.336
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.586
2-Sided
95
-3.105
-2.066
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.550
2-Sided
95
-2.901
-2.199
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.7372
Mean Difference (Net)
0.071
2-Sided
95
-0.346
0.489
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00348
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Title
Measurements
OG0005.36± 2.096
OG0015.27± 1.572
OG0025.31± 1.835
OG003
Visit 1: Week 12
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Visit 3: Week 18
ParticipantsOG00039
ParticipantsOG00149
ParticipantsOG00288
ParticipantsOG00346
Visit 5: Week 24
ParticipantsOG00041
ParticipantsOG00147
ParticipantsOG00288
ParticipantsOG00343
Change from Baseline (Week 12)
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Change from Baseline (Week 18)
ParticipantsOG00039
ParticipantsOG00149
ParticipantsOG00288
ParticipantsOG00346
Change from Baseline (Week 24)
ParticipantsOG00041
ParticipantsOG00147
ParticipantsOG00288
ParticipantsOG00343
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.106
2-Sided
95
-3.502
-2.710
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.824
2-Sided
95
-3.235
-2.414
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.228
2-Sided
95
-3.553
-2.904
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.839
2-Sided
95
-3.221
-2.457
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.449
2-Sided
95
-2.828
-2.070
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.023
2-Sided
95
-3.328
-2.718
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG002
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.126
2-Sided
95
-3.354
-2.897
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
0.908
2-Sided
95
0.518
1.298
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
1.291
2-Sided
95
0.902
1.679
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
0.2772
Mean Difference (Net)
0.174
2-Sided
95
-0.142
0.490
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-4.014
2-Sided
95
-4.750
-3.278
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-4.115
2-Sided
95
-4.865
-3.365
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.403
2-Sided
95
-4.005
-2.801
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.747
2-Sided
95
-4.473
-3.020
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.740
2-Sided
95
-4.461
-3.018
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.197
2-Sided
95
-3.784
-2.610
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-3.300
2-Sided
95
-3.678
-2.921
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
Mixed Models Analysis
0.3480
Mean Difference (Net)
-0.206
2-Sided
95
-0.638
0.226
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001130
OG002257
OG003139
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002257
ParticipantsOG003139
Title
Measurements
OG0007.003± 2.3185
OG0016.947± 1.9468
OG0026.974± 2.1346
OG003
Visit 5: Week 6
ParticipantsOG000124
ParticipantsOG001125
ParticipantsOG002249
ParticipantsOG003135
Visit 7: Week 12
ParticipantsOG000110
ParticipantsOG001119
ParticipantsOG002229
ParticipantsOG003128
Change from Baseline (Week 6)
ParticipantsOG000124
ParticipantsOG001125
ParticipantsOG002249
ParticipantsOG003135
Change from Baseline (Week 12)
ParticipantsOG000110
ParticipantsOG001119
ParticipantsOG002229
ParticipantsOG003128
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)
Mixed Models Analysis
<0.0001
Mean Difference (Net)
-0.716
2-Sided
95
-0.951
-0.481
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)
OG000
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)
Mixed Models Analysis
<0.0001
Mean Difference (Net)
-0.686
2-Sided
95
-0.966
-0.406
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)
OG001
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-0.521
2-Sided
95
-0.755
-0.288
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)
OG001
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)
Mixed Models Analysis
0.0131
Mean Difference (Net)
-0.342
2-Sided
95
-0.612
-0.072
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)
OG002
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-0.514
2-Sided
95
-0.712
-0.316
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)
Mixed Models Analysis
0.0435
Mean Difference (Net)
-0.231
2-Sided
95
-0.455
-0.007
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)
Mixed Models Analysis
0.4012
Mean Difference (Net)
0.111
2-Sided
95
-0.149
0.371
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)
OG000
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)
Mixed Models Analysis
0.0133
Mean Difference (Net)
-0.485
2-Sided
95
-0.895
-0.074
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)
OG000
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-0.797
2-Sided
95
-1.277
-0.317
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)
OG001
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)
Mixed Models Analysis
0.2641
Mean Difference (Net)
-0.290
2-Sided
95
-0.699
0.119
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)
OG001
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)
Mixed Models Analysis
0.0639
Mean Difference (Net)
-0.453
2-Sided
95
-0.924
0.018
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)
OG002
OG003
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)
Mixed Models Analysis
0.0001
Mean Difference (Net)
-0.625
2-Sided
95
-0.945
-0.305
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)
OG000
OG001
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)
Mixed Models Analysis
0.0776
Mean Difference (Net)
-0.344
2-Sided
95
-0.725
0.038
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Title
Measurements
OG0006.547± 1.6295
OG0016.851± 1.8432
OG0026.704± 1.7406
OG003
Visit 1: Week 12
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00149
ParticipantsOG00289
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00147
ParticipantsOG00289
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00149
ParticipantsOG00289
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00147
ParticipantsOG00289
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0055
Mean Difference (Net)
-0.621
2-Sided
95
-1.055
-0.186
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0011
Mean Difference (Net)
-0.778
2-Sided
95
-1.240
-0.316
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-0.900
2-Sided
95
-1.260
-0.540
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0150
Mean Difference (Net)
-0.520
2-Sided
95
-0.938
-0.103
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1048
Mean Difference (Net)
-0.349
2-Sided
95
-0.771
0.074
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-0.846
2-Sided
95
-1.185
-0.507
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-0.873
2-Sided
95
-1.127
-0.619
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2525
Mean Difference (Net)
0.247
2-Sided
95
-0.178
0.671
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.6503
Mean Difference (Net)
0.098
2-Sided
95
-0.330
0.527
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1759
Mean Difference (Net)
0.239
2-Sided
95
-0.109
0.588
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0293
Mean Difference (Net)
-0.867
2-Sided
95
-1.674
-0.060
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0362
Mean Difference (Net)
-0.876
2-Sided
95
-1.714
-0.038
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-1.139
2-Sided
95
-1.809
-0.469
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0621
Mean Difference (Net)
-0.767
2-Sided
95
-1.559
0.025
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5259
Mean Difference (Net)
-0.447
2-Sided
95
-1.246
0.352
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-1.085
2-Sided
95
-1.736
-0.435
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-1.112
2-Sided
95
-1.532
-0.693
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8248
Mean Difference (Net)
-0.054
2-Sided
95
-0.535
0.427
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000125
OG001130
OG002255
OG003138
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000125
ParticipantsOG001130
ParticipantsOG002255
ParticipantsOG003138
Title
Measurements
OG00044.8± 14.15
OG00146.1± 12.56
OG00245.5± 13.35
OG003
Visit 5: Week 6
ParticipantsOG000122
ParticipantsOG001125
ParticipantsOG002247
ParticipantsOG003135
Visit 7: Week 12
ParticipantsOG000110
ParticipantsOG001119
ParticipantsOG002229
ParticipantsOG003128
Change from Baseline (Week 6)
ParticipantsOG000122
ParticipantsOG001125
ParticipantsOG002247
ParticipantsOG003135
Change from Baseline (Week 12)
ParticipantsOG000110
ParticipantsOG001119
ParticipantsOG002229
ParticipantsOG003128
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
2.821
2-Sided
95
1.369
4.273
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
3.468
2-Sided
95
1.850
5.086
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0022
Mean Difference (Net)
2.245
2-Sided
95
0.812
3.679
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
3.329
2-Sided
95
1.768
4.891
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
3.399
2-Sided
95
2.252
4.545
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0761
Mean Difference (Net)
1.250
2-Sided
95
-0.132
2.633
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0211
Mean Difference (Net)
1.778
2-Sided
95
0.269
3.286
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.3841
Mean Difference (Net)
1.570
2-Sided
95
-0.951
4.092
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.3934
Mean Difference (Net)
1.690
2-Sided
95
-1.084
4.464
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.7782
Mean Difference (Net)
0.995
2-Sided
95
-1.505
3.494
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.4576
Mean Difference (Net)
1.552
2-Sided
95
-1.171
4.274
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0849
Mean Difference (Net)
1.621
2-Sided
95
-0.224
3.466
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.9016
Mean Difference (Net)
0.139
2-Sided
95
-2.064
2.341
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00046
OG00149
OG00295
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00046
ParticipantsOG00149
ParticipantsOG00295
ParticipantsOG00349
Title
Measurements
OG00046.3± 13.05
OG00145.2± 12.29
OG00245.7± 12.61
OG003
Visit 1: Week 12
ParticipantsOG00046
ParticipantsOG00149
ParticipantsOG00295
ParticipantsOG00349
Visit 3: Week 18
ParticipantsOG00039
ParticipantsOG00148
ParticipantsOG00287
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00287
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00046
ParticipantsOG00149
ParticipantsOG00295
ParticipantsOG00349
Change from Baseline (Week 18)
ParticipantsOG00039
ParticipantsOG00148
ParticipantsOG00287
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00041
ParticipantsOG00146
ParticipantsOG00287
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0004
Mean Difference (Net)
5.587
2-Sided
95
2.511
8.662
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1141
Mean Difference (Net)
2.556
2-Sided
95
-0.620
5.732
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0007
Mean Difference (Net)
5.536
2-Sided
95
2.367
8.705
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
6.629
2-Sided
95
3.680
9.577
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0072
Mean Difference (Net)
4.083
2-Sided
95
1.118
7.047
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0023
Mean Difference (Net)
4.688
2-Sided
95
1.691
7.686
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
5.112
2-Sided
95
2.874
7.350
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.6030
Mean Difference (Net)
0.777
2-Sided
95
-2.165
3.720
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5053
Mean Difference (Net)
1.003
2-Sided
95
-1.960
3.967
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.6607
Mean Difference (Net)
0.674
2-Sided
95
-2.347
3.694
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1309
Mean Difference (Net)
4.809
2-Sided
95
-0.827
10.446
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.9776
Mean Difference (Net)
1.553
2-Sided
95
-4.212
7.318
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1422
Mean Difference (Net)
4.862
2-Sided
95
-0.939
10.663
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0334
Mean Difference (Net)
5.851
2-Sided
95
0.307
11.396
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5622
Mean Difference (Net)
3.080
2-Sided
95
-2.501
8.660
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2841
Mean Difference (Net)
4.014
2-Sided
95
-1.643
9.672
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0178
Mean Difference (Net)
4.438
2-Sided
95
0.774
8.103
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.6944
Mean Difference (Net)
0.847
2-Sided
95
-3.398
5.093
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001131
OG002258
OG003138
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001131
ParticipantsOG002258
ParticipantsOG003138
Title
Measurements
OG000377.138± 211.0106
OG001355.984± 177.9443
OG002366.397± 194.8302
OG003
Visit 5: Week 6
ParticipantsOG000124
ParticipantsOG001122
ParticipantsOG002246
ParticipantsOG003134
Visit 7: Week 12
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003128
Change from Baseline (Week 6)
ParticipantsOG000124
ParticipantsOG001122
ParticipantsOG002246
ParticipantsOG003134
Change from Baseline (Week 12)
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003128
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0031
Mean Difference (Net)
-35.556
2-Sided
95
-59.038
-12.075
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0371
Mean Difference (Net)
-31.350
2-Sided
95
-60.818
-1.882
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0043
Mean Difference (Net)
-34.356
2-Sided
95
-57.877
-10.834
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2091
Mean Difference (Net)
-18.096
2-Sided
95
-46.375
10.183
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0197
Mean Difference (Net)
-24.723
2-Sided
95
-45.473
-3.973
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.2353
Mean Difference (Net)
-13.595
2-Sided
95
-36.080
8.891
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.7329
Mean Difference (Net)
-4.759
2-Sided
95
-32.159
22.641
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.5420
Mean Difference (Net)
-21.962
2-Sided
95
-62.989
19.065
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.5234
Mean Difference (Net)
-26.591
2-Sided
95
-77.049
23.866
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.5975
Mean Difference (Net)
-20.761
2-Sided
95
-61.867
20.344
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.9331
Mean Difference (Net)
-13.337
2-Sided
95
-62.853
36.179
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2444
Mean Difference (Net)
-19.964
2-Sided
95
-53.637
13.709
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.5169
Mean Difference (Net)
-13.254
2-Sided
95
-53.427
26.919
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Title
Measurements
OG000331.217± 145.3767
OG001359.269± 204.4360
OG002345.677± 177.9266
OG003
Visit 1: Week 12
ParticipantsOG00046
ParticipantsOG00150
ParticipantsOG00296
ParticipantsOG00349
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00046
ParticipantsOG00150
ParticipantsOG00296
ParticipantsOG00349
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1359
Mean Difference (Net)
-40.174
2-Sided
95
-93.120
12.772
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0129
Mean Difference (Net)
-71.725
2-Sided
95
-127.961
-15.490
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3262
Mean Difference (Net)
-37.308
2-Sided
95
-112.293
37.678
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.4343
Mean Difference (Net)
-20.012
2-Sided
95
-70.468
30.444
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0967
Mean Difference (Net)
-44.657
2-Sided
95
-97.481
8.167
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.4198
Mean Difference (Net)
-28.974
2-Sided
95
-99.915
41.966
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2121
Mean Difference (Net)
-33.141
2-Sided
95
-85.475
19.193
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5445
Mean Difference (Net)
15.799
2-Sided
95
-35.614
67.212
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.9534
Mean Difference (Net)
1.583
2-Sided
95
-51.951
55.116
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8366
Mean Difference (Net)
7.584
2-Sided
95
-65.126
80.295
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5437
Mean Difference (Net)
-55.973
2-Sided
95
-154.862
42.916
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2974
Mean Difference (Net)
-73.308
2-Sided
95
-177.224
30.608
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.9026
Mean Difference (Net)
-44.892
2-Sided
95
-181.909
92.126
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8954
Mean Difference (Net)
-35.811
2-Sided
95
-132.513
60.891
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.7485
Mean Difference (Net)
-46.239
2-Sided
95
-146.766
54.288
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.9578
Mean Difference (Net)
-36.559
2-Sided
95
-169.770
96.653
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3635
Mean Difference (Net)
-40.725
2-Sided
95
-129.208
47.757
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8713
Mean Difference (Net)
-8.333
2-Sided
95
-110.097
93.431
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000126
OG001131
OG002257
OG003136
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000126
ParticipantsOG001131
ParticipantsOG002257
ParticipantsOG003136
Title
Measurements
OG000824.877± 726.5075
OG001761.598± 518.6039
OG002792.622± 628.7305
OG003
Visit 5: Week 6
ParticipantsOG000123
ParticipantsOG001122
ParticipantsOG002245
ParticipantsOG003132
Visit 7: Week 12
ParticipantsOG000110
ParticipantsOG001120
ParticipantsOG002230
ParticipantsOG003125
Change from Baseline (Week 6)
ParticipantsOG000123
ParticipantsOG001122
ParticipantsOG002245
ParticipantsOG003132
Change from Baseline (Week 12)
ParticipantsOG000110
ParticipantsOG001120
ParticipantsOG002230
ParticipantsOG003125
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0003
Mean Difference (Net)
-115.256
2-Sided
95
-177.973
-52.539
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0467
Mean Difference (Net)
-74.904
2-Sided
95
-148.706
-1.102
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-144.035
2-Sided
95
-206.668
-81.402
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0807
Mean Difference (Net)
-62.755
2-Sided
95
-133.221
7.710
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0095
Mean Difference (Net)
-68.830
2-Sided
95
-120.753
-16.907
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.9586
Mean Difference (Net)
-1.593
2-Sided
95
-61.873
58.687
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.9402
Mean Difference (Net)
-2.635
2-Sided
95
-71.714
66.443
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0390
Mean Difference (Net)
-113.663
2-Sided
95
-223.330
-3.996
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.4543
Mean Difference (Net)
-72.269
2-Sided
95
-199.091
54.554
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0051
Mean Difference (Net)
-142.442
2-Sided
95
-252.080
-32.805
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.6061
Mean Difference (Net)
-60.120
2-Sided
95
-184.286
64.046
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.1242
Mean Difference (Net)
-66.194
2-Sided
95
-150.672
18.284
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.8117
Mean Difference (Net)
-12.149
2-Sided
95
-112.350
88.052
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00348
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00348
Title
Measurements
OG000710.827± 429.3286
OG001750.519± 463.9992
OG002731.287± 445.6561
OG003
Visit 1: Week 12
ParticipantsOG00046
ParticipantsOG00150
ParticipantsOG00296
ParticipantsOG00347
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00346
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00343
Change from Baseline (Week 12)
ParticipantsOG00046
ParticipantsOG00150
ParticipantsOG00296
ParticipantsOG00347
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00346
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00343
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0567
Mean Difference (Net)
-111.957
2-Sided
95
-227.151
3.237
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2103
Mean Difference (Net)
-76.728
2-Sided
95
-197.025
43.569
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0052
Mean Difference (Net)
-169.735
2-Sided
95
-288.220
-51.251
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3490
Mean Difference (Net)
-52.505
2-Sided
95
-162.721
57.711
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8410
Mean Difference (Net)
-11.413
2-Sided
95
-123.333
100.507
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3465
Mean Difference (Net)
-53.565
2-Sided
95
-165.400
58.270
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0087
Mean Difference (Net)
-111.650
2-Sided
95
-194.865
-28.435
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2688
Mean Difference (Net)
63.944
2-Sided
95
-49.678
177.565
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0096
Mean Difference (Net)
151.222
2-Sided
95
37.114
265.330
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0023
Mean Difference (Net)
182.631
2-Sided
95
65.754
299.509
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1612
Mean Difference (Net)
-175.901
2-Sided
95
-390.865
39.063
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0396
Mean Difference (Net)
-227.950
2-Sided
95
-448.725
-7.175
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-352.366
2-Sided
95
-573.315
-131.418
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5616
Mean Difference (Net)
-116.449
2-Sided
95
-327.445
94.547
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2176
Mean Difference (Net)
-162.635
2-Sided
95
-375.570
50.299
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0242
Mean Difference (Net)
-236.196
2-Sided
95
-451.334
-21.059
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-294.281
2-Sided
95
-434.513
-154.050
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1524
Mean Difference (Net)
-116.170
2-Sided
95
-275.521
43.180
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001131
OG002258
OG003139
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001131
ParticipantsOG002258
ParticipantsOG003139
Title
Measurements
OG000230.4± 76.704
OG001222.8± 77.888
OG002226.6± 77.250
OG003
Visit 5: Week 6
ParticipantsOG000124
ParticipantsOG001126
ParticipantsOG002250
ParticipantsOG003136
Visit 7: Week 12
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003129
Change from Baseline (Week 6)
ParticipantsOG000124
ParticipantsOG001126
ParticipantsOG002250
ParticipantsOG003136
Change from Baseline (Week 12)
ParticipantsOG000111
ParticipantsOG001120
ParticipantsOG002231
ParticipantsOG003129
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-32.792
2-Sided
95
-39.375
-26.208
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-25.921
2-Sided
95
-33.398
-18.443
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-25.484
2-Sided
95
-31.990
-18.979
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-26.899
2-Sided
95
-34.135
-19.663
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-26.410
2-Sided
95
-31.716
-21.103
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0280
Mean Difference (Net)
-7.021
2-Sided
95
-13.278
-0.763
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0972
Mean Difference (Net)
-5.902
2-Sided
95
-12.881
1.077
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-25.771
2-Sided
95
-37.189
-14.353
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0005
Mean Difference (Net)
-20.019
2-Sided
95
-32.833
-7.205
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-18.463
2-Sided
95
-29.825
-7.101
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-20.997
2-Sided
95
-33.619
-8.375
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-20.508
2-Sided
95
-29.061
-11.955
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.8504
Mean Difference (Net)
0.978
2-Sided
95
-9.216
11.172
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Title
Measurements
OG000206.6± 60.303
OG001205.0± 57.117
OG002205.8± 58.381
OG003
Visit 1: Week 12
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00149
ParticipantsOG00289
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00147
ParticipantsOG00289
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00149
ParticipantsOG00289
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00147
ParticipantsOG00289
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-31.257
2-Sided
95
-41.957
-20.557
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-29.862
2-Sided
95
-44.234
-15.491
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-31.512
2-Sided
95
-46.971
-16.053
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-37.197
2-Sided
95
-47.522
-26.872
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-31.442
2-Sided
95
-44.960
-17.923
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-28.597
2-Sided
95
-43.340
-13.853
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-30.054
2-Sided
95
-40.943
-19.166
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2667
Mean Difference (Net)
-5.904
2-Sided
95
-16.370
4.563
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2085
Mean Difference (Net)
8.767
2-Sided
95
-4.950
22.485
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1041
Mean Difference (Net)
12.455
2-Sided
95
-2.595
27.505
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0058
Mean Difference (Net)
-25.353
2-Sided
95
-45.410
-5.295
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0010
Mean Difference (Net)
-38.630
2-Sided
95
-65.062
-12.197
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0005
Mean Difference (Net)
-43.967
2-Sided
95
-72.443
-15.491
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0003
Mean Difference (Net)
-31.293
2-Sided
95
-51.159
-11.428
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0004
Mean Difference (Net)
-40.209
2-Sided
95
-65.941
-14.477
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0011
Mean Difference (Net)
-41.052
2-Sided
95
-68.965
-13.138
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-42.509
2-Sided
95
-60.902
-24.116
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.7835
Mean Difference (Net)
-2.915
2-Sided
95
-23.855
18.025
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000110
OG001118
OG002128
Title
Denominators
Categories
Title
Measurements
OG000-0.564± 1.8111
OG001-0.389± 1.7261
OG0020.227± 1.6425
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
Mixed Models Analysis
0.0002
Mean Difference (Net)
-0.769
2-Sided
95
-1.228
-0.309
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
Mixed Models Analysis
0.0175
Mean Difference (Net)
-0.520
2-Sided
95
-0.972
-0.068
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000110
OG001117
OG002127
Title
Denominators
Categories
Title
Measurements
OG0003.3± 6.68
OG0012.3± 6.95
OG0020.4± 7.54
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
Mixed Models Analysis
0.0362
Mean Difference (Net)
2.408
2-Sided
95
0.110
4.705
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2142
Mean Difference (Net)
1.692
2-Sided
95
-0.569
3.953
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000108
OG001120
OG002125
Title
Denominators
Categories
Title
Measurements
OG000-61.644± 138.3599
OG001-18.092± 135.9049
OG002-11.452± 133.6618
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0250
Mean Difference (Net)
-39.501
2-Sided
95
-75.396
-3.605
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.9997
Mean Difference (Net)
-2.940
2-Sided
95
-37.896
32.016
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000110
OG001120
OG002124
Title
Denominators
Categories
Title
Measurements
OG000-47.736± 488.1213
OG001-55.751± 486.6897
OG002-3.878± 414.5263
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.6778
Mean Difference (Net)
-54.398
2-Sided
95
-177.281
68.485
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.7497
Mean Difference (Net)
-48.395
2-Sided
95
-168.697
71.908
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000111
OG001119
OG002129
Title
Denominators
Categories
Title
Measurements
OG000-23.71± 52.739
OG001-26.02± 46.433
OG002-7.056± 37.619
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0003
Mean Difference (Net)
-20.010
2-Sided
95
-32.447
-7.573
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-22.566
2-Sided
95
-34.837
-10.295
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000112
OG001120
OG002128
Title
Denominators
Categories
Title
Measurements
OG000-191.327± 220.6982
OG001-160.201± 192.1456
OG002-15.898± 149.1447
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-179.365
2-Sided
95
-225.708
-133.022
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-153.220
2-Sided
95
-198.930
-107.509
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000110
OG001120
OG002128
Title
Denominators
Categories
Title
Measurements
OG000-2.57± 2.363
OG001-2.44± 2.187
OG0020.07± 1.920
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.569
2-Sided
95
-3.084
-2.054
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
<.0001
Mean Difference (Net)
-2.586
2-Sided
95
-3.092
-2.081
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Units
Counts
Participants
OG000112
OG001121
Title
Denominators
Categories
Exhaled CO at Week 12
ParticipantsOG000112
ParticipantsOG001121
Title
Measurements
eCO ≤ 5
OG00076
OG00177
eCO < 5 - ≤ 8
OG00013
OG00121
eCO > 8
OG00023
OG00123
Exhaled CO at Week 24
ParticipantsOG00042
ParticipantsOG00148
Title
Measurements
eCO ≤ 5
OG00035
OG001
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000100
OG001112
OG002212
OG003115
Title
Denominators
Categories
Screening (Baseline)
Title
Measurements
OG00091.059± 13.9979
OG00191.335± 12.8396
OG00291.205± 13.3671
OG00390.139± 13.4146
Week 12
Title
Measurements
OG00089.989± 13.7140
OG00190.918± 13.3174
OG00290.480± 13.4818
OG003
Change from Baseline at Week 12
Title
Measurements
OG000-1.070± 6.5798
OG001-0.416± 5.4848
OG002-0.725± 6.0205
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.0839
Mean Difference (Net)
1.42
2-Sided
95
-0.19
3.04
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.0089
Mean Difference (Net)
2.10
2-Sided
95
0.53
3.66
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000100
OG001112
OG002212
OG003115
Title
Denominators
Categories
Screening (Baseline)
Title
Measurements
OG00092.709± 12.7747
OG00193.789± 11.7222
OG00293.280± 12.2126
OG00392.809± 12.2784
Week 12
Title
Measurements
OG00091.733± 13.3234
OG00192.730± 11.9222
OG00292.260± 12.5822
OG003
Change from Baseline at Week 12
Title
Measurements
OG000-0.976± 5.1281
OG001-1.059± 5.3244
OG002-1.020± 5.2205
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.7101
Mean Difference (Net)
0.26
2-Sided
95
-1.13
1.66
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.7325
Mean Difference (Net)
0.24
2-Sided
95
-1.12
1.59
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000100
OG001112
OG002212
OG003115
Title
Denominators
Categories
Screening (Baseline)
Title
Measurements
OG00098.202± 7.5989
OG00197.535± 7.9699
OG00297.849± 7.7859
OG00397.243± 8.1131
Week 12
Title
Measurements
OG00098.219± 7.7279
OG00198.135± 7.3706
OG00298.175± 7.5234
OG003
Change from Baseline at Week 12
Title
Measurements
OG0000.017± 4.4796
OG0010.600± 3.3508
OG0020.325± 3.9251
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.0136
Mean Difference (Net)
1.48
2-Sided
95
0.31
2.66
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
ANCOVA
0.0009
Mean Difference (Net)
1.94
2-Sided
95
0.80
3.08
The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.
Equivalence
Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG000127
OG001131
OG002258
OG003138
Title
Denominators
Categories
Visit 3 (Baseline): Week 1
ParticipantsOG000127
ParticipantsOG001131
ParticipantsOG002258
ParticipantsOG003138
Title
Measurements
OG00010.865± 5.6124
OG00110.629± 5.5776
OG00210.745± 5.5851
OG003
Visit 5: Week 6
ParticipantsOG000124
ParticipantsOG001123
ParticipantsOG002247
ParticipantsOG003134
Visit 7: Week 12
ParticipantsOG000112
ParticipantsOG001119
ParticipantsOG002231
ParticipantsOG003127
Change from Baseline (Week 6)
ParticipantsOG000124
ParticipantsOG001123
ParticipantsOG002247
ParticipantsOG003134
Change from Baseline (Week 12)
ParticipantsOG000112
ParticipantsOG001119
ParticipantsOG002231
ParticipantsOG003127
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.9294
Mean Difference (Net)
0.038
2-Sided
95
-0.795
0.870
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.5290
Mean Difference (Net)
0.277
2-Sided
95
-0.587
1.142
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.2291
Mean Difference (Net)
-0.508
2-Sided
95
-1.337
0.321
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2179
Mean Difference (Net)
0.525
2-Sided
95
-0.311
1.361
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.2002
Mean Difference (Net)
0.401
2-Sided
95
-0.213
1.016
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.4760
Mean Difference (Net)
-0.290
2-Sided
95
-1.089
0.509
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0914
Mean Difference (Net)
-0.699
2-Sided
95
-1.512
0.113
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.9705
Mean Difference (Net)
0.328
2-Sided
95
-1.122
1.777
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.3280
Mean Difference (Net)
0.977
2-Sided
95
-0.512
2.465
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
Mixed Models Analysis
0.9951
Mean Difference (Net)
-0.218
2-Sided
95
-1.667
1.230
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.1367
Mean Difference (Net)
1.225
2-Sided
95
-0.244
2.693
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.0294
Mean Difference (Net)
1.101
2-Sided
95
0.111
2.091
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
Mixed Models Analysis
0.6792
Mean Difference (Net)
-0.248
2-Sided
95
-1.424
0.928
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)
OG001
Test 2
Exclusive ad libitum use of test e-Vapor Product Nu Mark LLC, MarkTen® XL Bold MENTHOL* without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
*Product no longer sold commercially
Experimental: Test Product 2: Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
OG002
Test 1 + Test 2 Group
Combined e-Vapor Use Group
OG003
Control
Continue smoking under ad libitum use of subjects' own brand of conventional lit-end cigarettes, without use of any other type of tobacco/nicotine containing product, for the entire duration of study participation.
Units
Counts
Participants
OG00047
OG00150
OG00297
OG00349
Title
Denominators
Categories
Baseline: Week 1
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Title
Measurements
OG00010.107± 4.9952
OG00110.684± 5.2636
OG00210.404± 5.1168
OG003
Visit 1: Week 12
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Visit 3: Week 18
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Visit 5: Week 24
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Change from Baseline (Week 12)
ParticipantsOG00047
ParticipantsOG00150
ParticipantsOG00297
ParticipantsOG00349
Change from Baseline (Week 18)
ParticipantsOG00040
ParticipantsOG00148
ParticipantsOG00288
ParticipantsOG00347
Change from Baseline (Week 24)
ParticipantsOG00042
ParticipantsOG00148
ParticipantsOG00290
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.4012
Mean Difference (Net)
0.638
2-Sided
95
-0.860
2.137
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0201
Mean Difference (Net)
2.163
2-Sided
95
0.343
3.983
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1709
Mean Difference (Net)
1.210
2-Sided
95
-0.528
2.948
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0307
Mean Difference (Net)
1.593
2-Sided
95
0.150
3.035
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0691
Mean Difference (Net)
1.588
2-Sided
95
-0.126
3.302
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0034
Mean Difference (Net)
2.487
2-Sided
95
0.838
4.137
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0034
Mean Difference (Net)
1.849
2-Sided
95
0.622
3.075
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.8123
Mean Difference (Net)
-0.178
2-Sided
95
-1.654
1.299
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5879
Mean Difference (Net)
-0.480
2-Sided
95
-2.226
1.267
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.4910
Mean Difference (Net)
-0.596
2-Sided
95
-2.304
1.111
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.9673
Mean Difference (Net)
0.816
2-Sided
95
-1.967
3.599
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.1787
Mean Difference (Net)
2.643
2-Sided
95
-0.683
5.968
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.5243
Mean Difference (Net)
1.806
2-Sided
95
-1.406
5.018
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3956
Mean Difference (Net)
1.770
2-Sided
95
-0.966
4.507
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.3810
Mean Difference (Net)
2.068
2-Sided
95
-1.160
5.295
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG001
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0557
Mean Difference (Net)
3.084
2-Sided
95
-0.049
6.216
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG002
OG003
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.0195
Mean Difference (Net)
2.445
2-Sided
95
0.400
4.490
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
OG000
OG001
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)
Mixed Models Analysis
0.2817
Mean Difference (Net)
-1.277
2-Sided
95
-3.615
1.060
LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.
Equivalence
Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)