Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Study Overview
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Brief Summary
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A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Official Title
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A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: tiotropium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria: post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years. Subjects must have a Medical Research Council (MRC) dyspnea score >= 2. Exclusion criteria: Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Oral inhalation once daily of placebo matching tiotropium via handihaler | Drug: Placebo<br>* Oral inhalation once daily of placebo matching tiotropium via handihaler<br>|
| Experimental: tiotropium<br>Oral inhalation once daily of 18mcg tiotropium via handihaler | Drug: tiotropium<br>* Oral inhalation once daily of 18mcg tiotropium via handihaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) | Change = Week 24 Value - Baseline Value | baseline, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Baseline | 
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Baseline, week 8 | 
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Baseline, week 16 | 
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24) | Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | Baseline, week 24 | 
| Peak Forced Expiratory Volume in 1 Second (Baseline) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. | Baseline | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Baseline, week 8 | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Baseline, week 16 | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | Baseline, week 24 | 
| Forced Expiratory Volume in 1 Second (Baseline, Pre-dose) | Forced expiratory volume in 1 second (baseline, pre-dose) | Baseline | 
| Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes) | Forced expiratory volume in 1 second (baseline, 30 minutes) | baseline, 30 minutes | 
| Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes) | Forced expiratory volume in 1 second (baseline, 60 minutes) | baseline, 60 minutes | 
| Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes) | Forced expiratory volume in 1 second (baseline, 120 minutes) | Baseline, 120 minutes | 
| Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes) | Forced expiratory volume in 1 second (baseline, 180 minutes) | Baseline, 180 minutes | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose) | Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose) | baseline, week 8, pre-dose | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes) | Baseline, week 8, 30 minutes | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes) | baseline, week 8, 60 minutes | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes) | baseline, week 8, 120 minutes | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes) | Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes) | baseline, week 8, 180 minutes | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose) | Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose) | baseline, week 16, pre-dose | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes) | Baseline, week 16, 30 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes) | baseline, week 16, 60 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes) | baseline, week 16, 120 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes) | baseline, week 16, 180 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose) | baseline, week 24, pre-dose | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes) | baseline, week 24, 30 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes) | baseline, week 24, 60 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes) | baseline, week 24, 120 minutes | 
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes) | Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes) | baseline, week 24, 180 minutes | 
| FVC AUC0-3 at Baseline | Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) | baseline | 
| FVC AUC0-3 at Week 8 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8) | baseline, week 8 | 
| FVC AUC0-3 at Week 16 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16) | baseline, week 16 | 
| FVC AUC0-3 at Week 24 Minus Baseline | Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24) | baseline, week 24 | 
| Trough Forced Vital Capacity (Baseline) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | baseline | 
| Change From Baseline in Trough Forced Vital Capacity (at Week 8) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | baseline, week 8 | 
| Change From Baseline in Trough Forced Vital Capacity (at Week 16) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | baseline, week 16 | 
| Change From Baseline in Trough Forced Vital Capacity (at Week 24) | Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication. | baseline, week 24 | 
| Peak Forced Vital Capacity (FVC) (Baseline) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. | baseline | 
| Change From Baseline in Peak Forced Vital Capacity (at Week 8) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | baseline, week 8 | 
| Change From Baseline in Peak Forced Vital Capacity (at Week 16) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | baseline, week 16 | 
| Change From Baseline in Peak Forced Vital Capacity (at Week 24) | Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit. | baseline, week 24 | 
| Forced Vital Capacity (Baseline, Pre-dose) | Forced vital capacity (baseline, pre-dose) | baseline | 
| Forced Vital Capacity (Baseline, 30 Minutes) | Forced vital capacity (baseline, 30 minutes) | baseline, 30 minutes | 
| Forced Vital Capacity (Baseline, 60 Minutes) | Forced vital capacity (baseline, 60 minutes) | baseline, 60 minutes | 
| Forced Vital Capacity (Baseline, 120 Minutes) | Forced vital capacity (baseline, 120 minutes) | baseline, 120 minutes | 
| Forced Vital Capacity (Baseline, 180 Minutes) | Forced vital capacity (baseline, 180 minutes) | baseline, 180 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose) | Change from baseline in forced vital capacity (week 8, pre-dose) | baseline, week 8, pre-dose | 
| Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes) | Change from baseline in forced vital capacity (week 8, 30 minutes) | baseline, week 8, 30 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes) | Change from baseline in forced vital capacity (week 8, 60 minutes) | baseline, week 8, 60 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes) | Change from baseline in forced vital capacity (week 8, 120 minutes) | baseline, week 8, 120 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes) | Change from baseline in forced vital capacity (week 8, 180 minutes) | baseline, week 8, 180 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose) | Change from baseline in forced vital capacity (week 16, pre-dose) | baseline, week 16, pre-dose | 
| Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes) | Change from baseline in forced vital capacity (week 16, 30 minutes) | baseline, week 16, 30 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes) | Change from baseline in forced vital capacity (week 16, 60 minutes) | baseline, week 16, 60 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes) | Change from baseline in forced vital capacity (week 16, 120 minutes) | baseline, week 16, 120 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes) | Change from baseline in forced vital capacity (week 16, 180 minutes) | baseline, week 16, 180 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose) | Change from baseline in forced vital capacity (week 24, pre-dose) | baseline, week 24, pre-dose | 
| Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes) | Change from baseline in forced vital capacity (week 24, 30 minutes) | baseline, week 24, 30 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes) | Change from baseline in forced vital capacity (week 24, 60 minutes) | baseline, week 24, 60 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes) | Change from baseline in forced vital capacity (week 24, 120 minutes) | baseline, week 24, 120 minutes | 
| Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes) | Change from baseline in forced vital capacity (week 24, 180 minutes) | baseline, week 24, 180 minutes | 
| Albuterol Use p.r.n. (Baseline) | Number of days that participants used albuterol prn per week | baseline | 
| Change From Baseline in Albuterol Use p.r.n. - (Week 4) | Difference in number of days that participants used albuterol prn per week between week 4 and baseline | baseline, week 4 | 
| Change From Baseline in Albuterol Use p.r.n. - (Week 8) | Difference in number of days that participants used albuterol prn per week between week 8 and baseline | baseline, week 8 | 
| Change From Baseline in Albuterol Use p.r.n. -(Week 12) | Difference in number of days that participants used albuterol prn per week between week 12 and baseline | baseline, week 12 | 
| Change From Baseline in Albuterol Use p.r.n. - (Week 16) | Difference in number of days that participants used albuterol prn per week between week 16 and baseline | baseline, week 16 | 
| Change From Baseline in Albuterol Use p.r.n. -(Week 20) | Difference in number of days that participants used albuterol prn per week between week 20 and baseline | baseline, week 20 | 
| Change From Baseline in Albuterol Use p.r.n. - (Week 24) | Difference in number of days that participants used albuterol prn per week between week 24 and baseline | baseline, week 24 | 
| Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | baseline | 
| Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | week 12 | 
| Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24) | The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | week 24 | 
| Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | baseline | 
| Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | week 12 | 
| Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24) | The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent. | week 24 | 
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | baseline | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | baseline, week 4 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | baseline, week 8 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | baseline, week 12 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | baseline, week 16 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | baseline, week 20 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | baseline, week 24 | 
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | baseline | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | baseline, week 4 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | baseline, week 8 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | baseline, week 12 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | baseline, week 16 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | baseline, week 20 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | baseline, week 24 | 
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | baseline | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | baseline, week 4 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | baseline, week 8 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | baseline, week 12 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | baseline, week 16 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | baseline, week 20 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | baseline, week 24 | 
| Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. | baseline | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline. | baseline, week 4 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline. | baseline, week 8 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline. | baseline, week 12 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline. | baseline, week 16 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline. | baseline, week 20 | 
| Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24) | WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline. | baseline, week 24 | 
| Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm. | baseline | 
| Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 4 | 
| Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 8 | 
| Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 12 | 
| Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 16 | 
| Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 20 | 
| Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 24 | 
| Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 4 | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 8 | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 12 | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 16 | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 20 | 
| Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day | Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm | baseline, week 24 | 
| Number of Participants With Healthy Lifestyle (Baseline) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | baseline | 
| Number of Participants With Healthy Lifestyle (Week 4) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 4 | 
| Number of Participants With Healthy Lifestyle (Week 8) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 8 | 
| Number of Participants With Healthy Lifestyle (Week 12) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 12 | 
| Number of Participants With Healthy Lifestyle (Week 16) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 16 | 
| Number of Participants With Healthy Lifestyle (Week 20) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 20 | 
| Number of Participants With Healthy Lifestyle (Week 24) | Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no | week 24 | 
| Active Energy Expenditure (Baseline) | The amount of energy (kcal/day) that a person uses while physically active. | baseline | 
| Change From Baseline in Active Energy Expenditure (Week 4) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 4 | 
| Change From Baseline in Active Energy Expenditure (Week 8) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 8 | 
| Change From Baseline in Active Energy Expenditure (Week 12) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 12 | 
| Change From Baseline in Active Energy Expenditure (Week 16) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 16 | 
| Change From Baseline in Active Energy Expenditure (Week 20) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 20 | 
| Change From Baseline in Active Energy Expenditure (Week 24) | The amount of energy (kcal/day) that a person uses while physically active. | baseline, week 24 | 
| Number of Steps Per Day (Baseline) | Number of steps per day (baseline) | baseline | 
| Change From Baseline in Number of Steps Per Day (Week 4) | Change from baseline in number of steps per day (week 4) | baseline, week 4 | 
| Change From Baseline in Number of Steps Per Day(Week 8) | Change from baseline in number of steps per day (week 8) | baseline, week 8 | 
| Change From Baseline in Number of Steps Per Day (Week 12) | Change from baseline in Number of steps per day (week 12) | baseline, week 12 | 
| Change From Baseline in Number of Steps Per Day (Week 16) | Change from baseline in number of steps per day (week 16) | baseline, week 16 | 
| Change From Baseline in Number of Steps Per Day (Week 20) | Change from baseline in number of steps per day (week 20) | baseline, week 20 | 
| Change From Baseline in Number of Steps Per Day (Week 24) | Change from baseline in number of steps per day (week 24) | baseline, week 24 |