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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, week 24

Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)

Forced expiratory volume in 1 second (baseline, pre-dose)

Time frame: Baseline

Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)

Forced expiratory volume in 1 second (baseline, 30 minutes)

Time frame: baseline, 30 minutes

Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)

Forced expiratory volume in 1 second (baseline, 60 minutes)

Time frame: baseline, 60 minutes

Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)

Forced expiratory volume in 1 second (baseline, 120 minutes)

Time frame: Baseline, 120 minutes

Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)

Forced expiratory volume in 1 second (baseline, 180 minutes)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: baseline, week 24, 180 minutes

FVC AUC0-3 at Baseline

Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, week 24

Forced Vital Capacity (Baseline, Pre-dose)

Forced vital capacity (baseline, pre-dose)

Time frame: baseline

Forced Vital Capacity (Baseline, 30 Minutes)

Forced vital capacity (baseline, 30 minutes)

Time frame: baseline, 30 minutes

Forced Vital Capacity (Baseline, 60 Minutes)

Forced vital capacity (baseline, 60 minutes)

Time frame: baseline, 60 minutes

Forced Vital Capacity (Baseline, 120 Minutes)

Forced vital capacity (baseline, 120 minutes)

Time frame: baseline, 120 minutes

Forced Vital Capacity (Baseline, 180 Minutes)

Forced vital capacity (baseline, 180 minutes)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: baseline, week 24, 180 minutes

Albuterol Use p.r.n. (Baseline)

Number of days that participants used albuterol prn per week

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: week 24

Active Energy Expenditure (Baseline)

The amount of energy (kcal/day) that a person uses while physically active.

Time frame: baseline

Change From Baseline in Active Energy Expenditure (Week 4)

The amount of energy (kcal/day) that a person uses while physically active.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, week 24

Number of Steps Per Day (Baseline)

Number of steps per day (baseline)

Time frame: baseline

Change From Baseline in Number of Steps Per Day (Week 4)

Change from baseline in number of steps per day (week 4)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: baseline, week 24