Effect of Switching From Cigarette Smoking to IQOS on Exe... | NCT03887117

Effect of Switching From Cigarette Smoking to IQOS on Exe... | NCT03887117 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IQOS-1	Active Comparator	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.	Other: IQOS + Exercise Training Program
IQOS-2	Active Comparator	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.	Other: IQOS without Exercise Training Program
Cigarette Smoking	Active Comparator	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.	Other: Cigarette Smoking + Exercise Training Program
Smoking Abstinence	Active Comparator	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.	Other: Smoking Abstinence + Exercise Training Program

Name	Type	Description	Arm Group Labels	Other Names
IQOS + Exercise Training Program	Other	Switch to IQOS use + participation in a training program	IQOS-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal Oxygen Uptake (VO2max, Absolute Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in absolute values [mL*min-1]).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in weight-adjusted [mLkg-1min-1] values).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in fat-free weight adjusted values [mLkg-1min-1]).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Exercise Capacity	To measure exercise capacity, by measuring time to complete a pre-defined work (determined as 25% more work than the study subject produced during baseline VO2max test) on a cycle ergometer (seconds).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)
Exercise Training Intensity: Cumulative Work	To measure cumulative work (calories) produced during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.	Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Exercise Training Intensity: Average Work Rate	To measure the average work rate (watt) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Smoking, healthy subject based on safety laboratory, ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
Subject has been smoking for at least three years prior to V1.
Subject has been smoking ≥ 10 cigarettes per day over the last 12 months. Smoking status will be verified by a urinary cotinine ≥ 200 ng/mL and CO exhaled breath test > 10 ppm both at V1 and V2.
Subject does not plan to quit smoking within 6 months after V1.

Exclusion Criteria:

Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary [such as but not limited to pulmonary oedema, asthma], and cardiovascular [such as, but not limited to myocardial infarction, unstable angina, uncontrolled arrhythmias, heart failure], disease) or any other clinically significant medical condition (including abnormal safety laboratory result as per CTCAE), which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject performs more than 45 min of vigorous physical activity per week.
Subject takes medication influencing blood volume such as erythropoietin, diuretics and beta blockers, or diabetic medications.
Subject cannot participate in the study for any reason other than medical as per the Investigator's judgment (e.g. psychological and/or social reason)
For women only: subject is pregnant (does not have negative pregnancy tests at V1 and at V2) or is breastfeeding.
For women of childbearing potential : female subject who does not agree to using an acceptable method of effective contraception during the entire study.
Subject has a BMI < 18.5 kg/m2 or BMI ≥ 30 kg/m2.
Subject has a positive urine drug screen.
Subject has been previously screened for this study.
Subject, or one of their family members (e.g., spouse, parent, sibling or child), is a current or former employee of the tobacco industry.
Subject, or one of their family members (e.g. spouse, parent, sibling or child), is an employee of the investigational site or any other parties involved in the study.
Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners, or subjects who are involuntarily incarcerated).

Contacts/Locations Module

Name	Affiliation	Role
Armin Schultz, MD	CRS Clinical Research Services Mannheim GmbH	Principal Investigator
Christelle Haziza, PhD	Philip Morris Products S.A.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
CRS Clinical Research Services Mannheim GmbH		Mannheim		D-68167	Germany

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program. IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program
FG001	IQOS-2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 2, 2019	Apr 19, 2021

Arm/Group Information

ID	Title	Description
BG000	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program. IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program
BG001	IQOS-2	No Training Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program. No Training: Switch to IQOS use only, without participation in a training program
BG002	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program. Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program
BG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program. Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program
BG004	Total	Total of all reporting groups

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
	BG00038.8± 12.8 BG00140.5± 13.4 BG00240.0± 10.9 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Height (cm)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000171± 10.3 BG001171± 10.4 BG002

Cigarettes smoked/day (last year)

Mean

Standard Deviation

cigarettes/day

Title

Denominators

Categories

Title	Measurements
	BG00018.8± 5.51 BG00117.2± 4.3 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

Maximal Oxygen Uptake (VO2max, Absolute Values)

To measure VO2max during maximal cycle ergometer exercise (expressed in absolute values [mL*min-1]).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mL/min

Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.
OG004	Dual-1	Subject randomized to IQOS-1 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
OG005	Dual-2	Subject randomized to IQOS-2 using ≥30 HeatSticks /month and ≥30 cigarettes/month.
OG006	Other	Other (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)

Units	Counts
Participants	OG00021 OG00119 OG00213 OG003

Title	Denominators	Categories
Acute Baseline (V3)	ParticipantsOG00020 ParticipantsOG00117 ParticipantsOG00213 ParticipantsOG003

Primary

Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)

To measure VO2max during maximal cycle ergometer exercise (expressed in weight-adjusted [mL*kg-1*min-1] values).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mL/(kg*min)

Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)

To measure VO2max during maximal cycle ergometer exercise (expressed in fat-free weight adjusted values [mL*kg-1*min-1]).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mL/(kg*min)

Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Exercise Capacity

To measure exercise capacity, by measuring time to complete a pre-defined work (determined as 25% more work than the study subject produced during baseline VO2max test) on a cycle ergometer (seconds).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

seconds

Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Exercise Training Intensity: Cumulative Work

To measure cumulative work (calories) produced during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

calorie

Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.
OG003

Primary

Exercise Training Intensity: Average Work Rate

To measure the average work rate (watt) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Watt

Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.
OG003	Other

Primary

Exercise Training Intensity: Average Heart Rate

To measure the average heart rate (bpm) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

beats/minute

Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.
OG003

Primary

Exercise Training Intensity: Time Spent at Maximal Heart Rate

To measure the time (seconds) spent at 0-50%, 50-60%, 60-70%, 70-80 % and >80% of maximal heart rate during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

seconds

Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Hemoglobin Mass

To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at Baseline (V3) and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Red Blood Cell Volume

To measure Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at Baseline (V3) and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Plasma Volume

To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at Baseline (V3) and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Total Blood Volume

To measure total blood volume (mL), measured with the carbon monoxide-rebreathing method.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at Baseline (V3) and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Capillary Blood Lactate Levels

To measure changes from baseline of Capillary blood lactate levels (mmol/L), measured (with a portable lactate analyzer) during VO2max test.

Not Posted

Measured at Baseline and week 15.

Participants

Primary

Ventilation at VO2 Max

To measure ventilation (L/min) at VO2max.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

L/min

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Respiratory Rate

To measure respiratory rate (breaths per minute) at VO2max.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

breaths/minute

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

VCO2

To measure VCO2 (L/min) at VO2 max.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

L/min

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Respiratory Exchange Ratio

To measure the respiratory exchange ratio (VCO2/VO2) at VO2max

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

ratio

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Rating of Perceived Capacity by Sex

To measure Rating of Perceived Capacity (RPC), determined by using the RPC scale. The RPC scale is a list of physical activities arranged in order, with a scale of values from least strenuous (1) to most exhausting (18 for women, 20 for men). Subjects choose the most strenuous activity, with corresponding value, which they could sustain for 30 minutes.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Rating of Perceived Capacity

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

Primary

Rating of Perceived Exertion

To measure changes from baseline of the Rating of Perceived Exertion, determined by using the Borg scale. The Borg RPE scale is a numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." Subjects choose a number from the scale that best describes their level of exertion during a physical activity.

Not Posted

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

Participants

Primary

Heart Rate

To measure changes from baseline of heart rate (bpm) during VO2max test.

Not Posted

Measured at Baseline, at week 1, and at week 15.

Participants

Primary

Oxygen Uptake

To measure changes from baseline of Oxygen uptake during VO2max test. (mL/min)

Not Posted

Measured at Baseline, at week 1, and at week 15.

Participants

Primary

High Density Lipoprotein (HDL)

To measure HDL concentrations in serum (mg/dL).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mg/dL

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Low Density Lipoprotein (LDL)

To measure LDL concentrations in serum (mg/dL).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mg/dL

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Very Low Density Lipoprotein (VLDL)

To measure VLDL concentrations in serum (mg/dL).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mg/dL

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

High Sensitivity C-reactive Protein (Hs-CRP)

To measure hs-CRP concentrations in serum (mg/dL).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mg/L

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Growth Hormone

To measure growth hormone concentrations in serum (ng/mL).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

ng/mL

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Hemoglobin A1c (HbA1c)

To measure glycosylated hemoglobin (HbA1c in whole blood).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

% (of red blood cells)

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Resting Systolic Blood Pressure

To measure resting systolic blood pressure in mmHg.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

mmHg

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Resting Pulse Rate

To measure resting heart rate in bpm.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

beats/minute

Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Body Fat

To measure body fat as a percentage.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

% (body fat)

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Waist Circumference

To measure waist circumference in cm.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Body Weight

To measure body weight in kilograms.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

Measured at each visit, starting from Baseline (V3) until week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Exhaled Carbon Monoxide

To measure exhaled carbon monoxide (ppm).

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

ppm

Measured at each visit, starting from Baseline (V3) until week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Primary

Carboxyhemoglobin

To measure Carboxyhemoglobin (COHb), assayed from whole blood. Expressed as % of saturation of hemoglobin.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

% (of saturation of hemoglobin)

Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

NEQ

To measure Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

mg/g creat

Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Total NNAL

To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

pg/mg creat

Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

CEMA

To measure 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Geometric Mean

95% Confidence Interval

ng/mg creat

Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Nicotine/Tobacco Product Use (Cigarettes)

To measure self-reported number of any nicotine/tobacco product used on a daily basis.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

cigarettes per day

Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Nicotine/Tobacco Product Use (HeatSticks)

To measure self-reported number of any nicotine/tobacco product used on a daily basis.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

heatsticks per day

Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Primary

Nicotine/Tobacco Product Use (E-cigarettes)

To measure self-reported number of any nicotine/tobacco product used on a daily basis.

AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Posted

Mean

95% Confidence Interval

e-cigarettes per day

Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.

ID	Title	Description
OG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
OG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
OG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
OG003	Smoking Abstinence

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cigarette Smoking	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program. Cigarette Smoking + Exercise Training Program: Continue to smoke cigarettes + participation in a training program	22	0	22	12	22
EG001	IQOS-1	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program. IQOS + Exercise Training Program: Switch to IQOS use + participation in a training program	22	0	22	10	22
EG002	IQOS-2	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.	13	1	13	8	13
EG003	Smoking Abstinence	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program. Smoking Abstinence + Exercise Training Program: Switch to smoking abstinence + participation in a training program	24	1	24	12	24
EG004	Other	Other product use (use of <30 HeatSticks/month and 5-30 cig/month or other forms of product use)	12	0	12	5	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk EG0031 events1 affected24 at risk EG004
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MeDRA Version 21.0	Non-systematic Assessment	EG0008 events8 affected22 at risk EG0013 events3 affected22 at risk EG0023 events3 affected13 at risk EG0033 events3 affected24 at risk EG0043 events3 affected12 at risk
Gastroenteritis	Infections and infestations	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk EG003
Gastrointestinal infection	Infections and infestations	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0003 events3 affected22 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk EG003
Blood Tryglycerides Increased	Investigations	MeDRA Version 21.0	Non-systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected22 at risk EG0021 events1 affected13 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected22 at risk EG0020 events0 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk EG003
Dental caries	Gastrointestinal disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected22 at risk EG0022 events2 affected13 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected22 at risk EG0020 events0 affected13 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk EG003
Headache	Nervous system disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected22 at risk EG0021 events1 affected13 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MeDRA Version 21.0	Non-systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected22 at risk EG0020 events0 affected13 at risk EG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG0001823(1686 to 1960) OG0012062(1823 to 2300) OG0022156(1747 to 2565) OG003

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321
- ParticipantsOG0040
- ParticipantsOG0050
- ParticipantsOG0065

Title	Measurements
	OG0001977(1807 to 2147) OG0012178(1889 to 2468) OG0022150(1709 to 2591) OG003

Title

Denominators

Categories

Acute Baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG00027.3(24.8 to 29.8) OG00127.4(24.9 to 29.9) OG00228.9(24.6 to 33.3) OG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute Baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG00037.5(34.4 to 40.5) OG00138.4(35.3 to 41.6) OG00238.3(34.0 to 42.6) OG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute Baseline (V3)

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG0002283(2033 to 2534) OG0012366(2109 to 2623) OG0022330(2013 to 2648) OG003

Acute Effect (V4)

- ParticipantsOG00019
- ParticipantsOG00114
- ParticipantsOG00212
- ParticipantsOG00319

Training Effect (V43)

- ParticipantsOG00019
- ParticipantsOG00118
- ParticipantsOG00211
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V5)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

Title	Measurements
	OG000169(145 to 193) OG001222(196 to 249) OG002208(176 to 239) OG003

V14

- ParticipantsOG00021
- ParticipantsOG00118
- ParticipantsOG00222
- ParticipantsOG0034

V29

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

V41

- ParticipantsOG00020
- ParticipantsOG00118
- ParticipantsOG00220
- ParticipantsOG0033

Title

Denominators

Categories

Baseline (V5)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

Title	Measurements
	OG00070.7(61.1 to 80.3) OG00187.6(77.2 to 98.0) OG00284.4(71.1 to 97.8) OG003

V14

- ParticipantsOG00021
- ParticipantsOG00118
- ParticipantsOG00222
- ParticipantsOG0034

V29

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

V41

- ParticipantsOG00020
- ParticipantsOG00118
- ParticipantsOG00220
- ParticipantsOG0033

Title

Denominators

Categories

Baseline (V5)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

Title	Measurements
	OG000125(119 to 131) OG001127(122 to 132) OG002123(117 to 128) OG003

V14

- ParticipantsOG00021
- ParticipantsOG00118
- ParticipantsOG00222
- ParticipantsOG0034

V29

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

V41

- ParticipantsOG00020
- ParticipantsOG00118
- ParticipantsOG00220
- ParticipantsOG0033

Title

Denominators

Categories

V5 (Baseline): 0-50%

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

Title	Measurements
	OG00033.7(1.00 to 66.4) OG00126.1(-7.68 to 59.8) OG00214.2(-2.15 to 30.5) OG003

V5 (Baseline): 50-60%

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

V5 (Baseline): 60-70%

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

V5 (Baseline): 70-80%

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

V5 (Baseline): >80%

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00221
- ParticipantsOG0034

Visit 14: 0-50%

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00221
- ParticipantsOG0034

Visit 14: 50-60%

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00221
- ParticipantsOG0034

Visit 14: 60-70%

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00221
- ParticipantsOG0034

Visit 14: 70-80%

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00221
- ParticipantsOG0034

Visit 14: >80%

- ParticipantsOG00019
- ParticipantsOG00117
- ParticipantsOG00221
- ParticipantsOG0034

Visit 29: 0-50%

- ParticipantsOG00020
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

Visit 29: 50-60%

- ParticipantsOG00020
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

Visit 29: 60-70%

- ParticipantsOG00020
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

Visit 29: 70-80%

- ParticipantsOG00020
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

Visit 29: >80%

- ParticipantsOG00020
- ParticipantsOG00119
- ParticipantsOG00222
- ParticipantsOG0033

Visit 41: 0-50%

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00220
- ParticipantsOG0033

Visit 41: 50-60%

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00220
- ParticipantsOG0033

Visit 41: 60-70%

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00220
- ParticipantsOG0033

Visit 41: 70-80%

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00220
- ParticipantsOG0033

Visit 41: >80%

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00220
- ParticipantsOG0033

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321
- ParticipantsOG0044

Title	Measurements
	OG000861(747 to 975) OG001796(701 to 891) OG002905(808 to 1003) OG003

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321
- ParticipantsOG0044

Title	Measurements
	OG0002541(2207 to 2875) OG0012353(2076 to 2629) OG0022681(2388 to 2975) OG003

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321
- ParticipantsOG0044

Title	Measurements
	OG0003429(3044 to 3814) OG0013156(2811 to 3500) OG0023558(3242 to 3874) OG003

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321
- ParticipantsOG0044

Title	Measurements
	OG0005970(5282 to 6657) OG0015508(4914 to 6102) OG0026239(5709 to 6770) OG003

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG00074.8(66.1 to 83.4) OG00178.9(70.4 to 87.4) OG00287.3(74.1 to 101) OG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute Baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG00034.5(31.3 to 37.7) OG00137.5(33.4 to 41.5) OG00237.1(30.7 to 43.4) OG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute Baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG0002.21(2.01 to 2.42) OG0012.36(2.07 to 2.65) OG0022.58(2.14 to 3.02) OG003

Acute Effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute baseline (V3)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320
- ParticipantsOG0041
- ParticipantsOG0051
- ParticipantsOG0068

Title	Measurements
	OG0001.18(1.14 to 1.22) OG0011.16(1.12 to 1.20) OG0021.19(1.14 to 1.23) OG003

Acute effect (V4)

- ParticipantsOG00020
- ParticipantsOG00117
- ParticipantsOG00213
- ParticipantsOG00320

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Acute Baseline - Female (V3)

- ParticipantsOG00013
- ParticipantsOG0019
- ParticipantsOG0026
- ParticipantsOG00310
- ParticipantsOG0040
- ParticipantsOG0051
- ParticipantsOG0064

Title	Measurements
	OG0007.77(5.75 to 9.79) OG0018.22(6.56 to 9.89) OG0028.17(5.83 to 10.5) OG003

Acute Effect - Female (V4)

- ParticipantsOG00013
- ParticipantsOG0019
- ParticipantsOG0026
- ParticipantsOG00310

Acute Baseline - Male (V3)

- ParticipantsOG0007
- ParticipantsOG0018
- ParticipantsOG0027
- ParticipantsOG00310

Acute Effect - Male (V4)

- ParticipantsOG0007
- ParticipantsOG0018
- ParticipantsOG0027
- ParticipantsOG00310

Training Baseline - Female (V3)

- ParticipantsOG00012
- ParticipantsOG0019
- ParticipantsOG0026
- ParticipantsOG00311

Training Effect - Female (V43)

- ParticipantsOG00012
- ParticipantsOG0019
- ParticipantsOG0025
- ParticipantsOG00311

Training Baseline - Male (V3)

- ParticipantsOG0009
- ParticipantsOG00110
- ParticipantsOG0027
- ParticipantsOG00311

Training Effect - Male (V43)

- ParticipantsOG0009
- ParticipantsOG00110
- ParticipantsOG0027
- ParticipantsOG00310

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00049.3(44.9 to 53.7) OG00148.2(40.3 to 56.0) OG00247.1(39.7 to 54.6) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG000124(107 to 141) OG001111(102 to 121) OG002122(109 to 136) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00014.7(9.05 to 20.4) OG00113.7(8.29 to 19.1) OG00215.8(10.2 to 21.4) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00020
- ParticipantsOG00118
- ParticipantsOG00211
- ParticipantsOG00321

Week 12 (V43)

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00212
- ParticipantsOG00318

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG0002.10(0.590 to 3.62) OG0012.19(0.983 to 3.40) OG0020.804(0.432 to 1.18) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG0002.15(0.726 to 3.58) OG0011.37(0.594 to 2.15) OG0022.49(0.0590 to 4.93) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG0005.44(5.34 to 5.53) OG0015.39(5.27 to 5.51) OG0025.38(5.22 to 5.53) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG000118(113 to 123) OG001121(116 to 127) OG002118(110 to 126) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00068.8(64.5 to 73.2) OG00168.2(63.8 to 72.5) OG00267.9(61.8 to 74.0) OG003

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00027.8(24.8 to 30.8) OG00128.2(24.6 to 31.8) OG00225.6(20.9 to 30.2) OG003

Acute Effect (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Training Effect (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00082.6(77.9 to 87.3) OG00183.7(79 to 88.5) OG00284.4(80 to 88.8) OG003

Acute Effect (V4)

- ParticipantsOG00017
- ParticipantsOG00114
- ParticipantsOG00212
- ParticipantsOG00319

Training Effect (V43)

- ParticipantsOG00018
- ParticipantsOG00114
- ParticipantsOG0028
- ParticipantsOG00317

Title

Denominators

Categories

Baseline (V3)

Title	Measurements
	OG00072(66.9 to 77.1) OG00175.7(69.7 to 81.7) OG00275.5(68.7 to 82.3) OG00377.5(72.2 to 82.8) OG00469.3(57.4 to 81.2)

Acute Effect (V4)

Title	Measurements
	OG00072.2(67 to 77.4) OG00175.7(69.7 to 81.6) OG00275.5(68.5 to 82.4) OG003

Month 1 (V5 - V13)

Title	Measurements
	OG00072(66.9 to 77) OG00175.7(69.8 to 81.6) OG00275.7(69 to 82.5) OG003

Month 2 (V14 - V27)

Title	Measurements
	OG00072(67.1 to 76.8) OG00175.8(69.7 to 81.9) OG00276.1(69.4 to 82.9) OG003

Month 3 (V28 - V43)

Title	Measurements
	OG00072(67.1 to 76.8) OG00175.8(69.7 to 81.9) OG00276.6(69.6 to 83.5) OG003

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00020.8(17.3 to 24.3) OG00120.8(16.6 to 25.0) OG00219.7(14.8 to 24.6) OG003

Week 1 (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0044

Title	Measurements
	OG0001.92(1.43 to 2.58) OG0012.37(1.82 to 3.09) OG0021.71(1.31 to 2.23) OG003

Week 1 (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG00014.9(11.7 to 19.0) OG00114.2(11.5 to 17.5) OG00210.5(7.55 to 14.5) OG003

Week 1 (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG000170(99.3 to 291) OG001239(184 to 310) OG002164(87.5 to 307) OG003

Week 1 (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Baseline (V3)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322
- ParticipantsOG0045

Title	Measurements
	OG000140(106 to 185) OG001170(143 to 202) OG002135(97.1 to 188) OG003

Week 1 (V4)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 6 (V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 10 (V28)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Week 12 (V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00212
- ParticipantsOG00321

Title

Denominators

Categories

Pre-randomization (V2-V3)

- ParticipantsOG00017
- ParticipantsOG00118
- ParticipantsOG00212
- ParticipantsOG00322
- ParticipantsOG0043

Title	Measurements
	OG00016.8(13.9 to 19.7) OG00119.0(16.4 to 21.5) OG00217.4(14.3 to 20.4) OG003

Week 1 (V3-V4)

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321

Up to month 1 (V3-V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Up to month 2 (V3-V26

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Overall (V3-V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Title

Denominators

Categories

Pre-randomization (V2-V3)

- ParticipantsOG00017
- ParticipantsOG00118
- ParticipantsOG00212
- ParticipantsOG00322
- ParticipantsOG0043

Title	Measurements
	OG0000(0 to 0) OG0010(0 to 0) OG0020(0 to 0) OG003

Week 1 (V3-V4)

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321

Up to month 1 (V3-V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Up to month 2 (V3-V26

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Overall (V3-V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Title

Denominators

Categories

Pre-randomization (V2-V3)

- ParticipantsOG00017
- ParticipantsOG00118
- ParticipantsOG00212
- ParticipantsOG00322
- ParticipantsOG0043

Title	Measurements
	OG0000(0 to 0) OG0010(0 to 0) OG0020.0952(0 to 0.305) OG003

Week 1 (V3-V4)

- ParticipantsOG00019
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00321

Up to month 1 (V3-V14)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Up to month 2 (V3-V26

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322

Overall (V3-V43)

- ParticipantsOG00021
- ParticipantsOG00119
- ParticipantsOG00213
- ParticipantsOG00322