Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China

Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30

The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline (Day 1 of Month 1) and at Month 30

Main Cohort: Absolute Values of CAT Score at Month 30

The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact.

Time frame: At Month 30

Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline

The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk). Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Main Cohort: Total Score of CAPTURE at Month 18

The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk).

Time frame: At Month 18

Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6

CID was defined as decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Baseline to Month 6 have been presented.

Time frame: Baseline (Day 1 of Month 1) to Month 6

Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18

CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 6 to 18 have been presented.

Time frame: Months 6 to 18

Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30

CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 18 to 30 have been presented.

Time frame: Months 18 to 30

Main Cohort: Number of Participants Who Died

Number of participants who died during study have been presented.

Time frame: Up to 30 months

Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6

E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 1 to 6 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 1 and 6. Change from Baseline was calculated by subtracting Baseline value from 1-6 month average total score value.

Time frame: Baseline (Day 1 of Month 1) and Months 1 to 6

Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24

E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 18 to 24 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 18 and 24. Change from Baseline was calculated by subtracting Baseline value from 18-24 month average total score value.

Time frame: Baseline (Day 1 of Month 1) and Months 18 to 24

Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6

The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 1 to 6 have been presented.

Time frame: Months 1 to 6

Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24

The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 18 to 24 have been presented.

Time frame: Months 18 to 24

Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7)

Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Baseline value was derived as the average value of first 7 days (Days 1 to 7 at Month 1).

Time frame: At Baseline (Days 1 to 7 at Month 1)

Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1)

Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 1 value was derived as the average of daily step data up to 30 days from study Day 8.

Time frame: Up to 30 days from study Day 8

Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19)

Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 18 value was derived as the average of daily step data up to 30 days from Month 18.

Time frame: Up to 30 days from Month 18 (Months 18 to 19)

Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline

Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30

Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen.

Time frame: At Month 30

Main Cohort: Absolute Values of C-Reactive Protein at Baseline

Blood samples were collected for the analysis of C-Reactive Protein. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Main Cohort: Absolute Values of C-Reactive Protein at Month 30

Blood samples were collected for the analysis of C-Reactive Protein.

Time frame: At Month 30

Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline

Blood samples were collected for the analysis of eosinophils and neutrophils. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30

Blood samples were collected for the analysis of eosinophils and neutrophils.

Time frame: At Month 30

Main Cohort: Absolute Values of Hemoglobin at Baseline

Blood samples were collected for the analysis of hemoglobin. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Main Cohort: Absolute Values of Hemoglobin at Months 30

Blood samples were collected for the analysis of hemoglobin.

Time frame: At Month 30

Sub-cohort: Absolute Values of Serum Interferon-gamma-inducible Protein -10 (IP-10) and Serum Soluble Receptor for Advanced Glycation End Products (sRAGE) at Baseline

Blood samples were collected at Baseline for the analysis of blood biomarkers serum IP-10 and serum sRAGE. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30

Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE.

Time frame: At Month 30

Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline

Blood samples were collected for the analysis of blood biomarker CC16. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of CC16 at Month 30

Blood samples were collected for the analysis of blood biomarker CC16.

Time frame: At Month 30

Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline

Blood samples were collected for the analysis of HbA1c. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: At Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of HbA1c at Month 30

Blood samples were collected for the analysis of HbA1c.

Time frame: At Month 30

Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods

Sputum microbiome evaluation involves extraction of deoxyribonucleic acid from sputum samples and analyzing it to identify the microbial community present in the samples using molecular methods. There were not enough samples for analysis. Consequently, data was not analyzed, and data will never be analyzed for this outcome measure in the future.

Time frame: Up to 30 months

Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline

Sputum samples were collected from the participants for assessment of total cell count. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Data was not collected for "Never Smoker Healthy Control" arm as sputum samples were not collected at Baseline visit for healthy control group as per the Protocol.

Time frame: At Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30

Sputum samples were collected from the participants for assessment of total cell count.

Time frame: At Month 30

Main Cohort: Number of Participants With COPD Medication

Number of participants with COPD medications received have been presented in separate categories. Data was collected in following categories: Naïve, long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA), inhaled corticosteroid (ICS)/LABA, LAMA/LABA, Triple (open), and Triple (closed).

Time frame: Up to 30 months

Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern

Data was collected in following categories: Step-up (the treatment pattern grade become larger than previous visit), Switch (the treatment pattern changed within a same grade (except grade 0), Stable (the treatment pattern remain the same (except grade 0), Step-down (participants receive treatment and the grade goes down compared with the previous visit), Stop/Missing (No treatment record in the period), and Naïve with respect to their treatment received. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Number of participants with change from Baseline in treatment pattern have been presented.

Time frame: Baseline (Day 1 of Month 1) and Month 30

Number of Participants With COPD Related Outpatient Visits

Number of participants with COPD related outpatient visits have been presented.

Time frame: Up to 30 months

Number of Participants With Non-COPD Related Outpatient Visits

Number of participants with non-COPD related outpatient visits have been presented.

Time frame: Up to 30 months

Number of Participants With COPD Related Emergency Visits

Number of participants with COPD related emergency visits have been presented.

Time frame: Up to 30 months

Number of Participants With Non-COPD Related Emergency Visits

Number of participants with non-COPD related emergency visits have been presented.

Time frame: Up to 30 months

Number of Participants With COPD Related Hospitalizations Visits

Number of participants with COPD related hospitalizations visits have been presented.

Time frame: Up to 30 months

Number of Participants With Non-COPD Related Hospitalizations Visits

Number of participants with non-COPD related hospitalizations visits have been presented.

Time frame: Up to 30 months

Direct Medical Costs Associated With COPD Medications During Study Period

Direct medical costs of out-of-pocket payment and basic insurance were included for following items: Hospital, Outpatient, Emergency, Participant check, Participant therapy and Prescribing costs.

Time frame: Up to 30 months

Sub-cohort: Absolute Values of Airway Wall Area at Baseline

Airway wall area, in ratio, at Baseline is calculated by dividing airway wall area by total airway area, using low-dose high-resolution computed tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of Airway Wall Area at Month 30

Airway wall area, in ratio, at Month 30 is calculated by dividing airway wall area by total airway area, using low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Average of Airway Major Inner Diameter at Baseline

Average of airway major inner diameter at Baseline is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Average of Airway Major Inner Diameter at Month 30

Average of airway major inner diameter at Month 30 is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Average of Airway Minor Inner Diameter at Baseline

Average of airway minor inner diameter at Baseline is the averaged shortest axis of the airway's cross-section in low-dose high-resolution Computed Tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Average of Airway Minor Inner Diameter at Month 30

Average of airway minor inner diameter at Month 30 is the averaged shortest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Total Airway Count at Baseline

Total airway count at Baseline is derived by summing the number of airway segments identified on low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Total Airway Count at Month 30

Total airway count at Month 30 is derived by summing the number of airway segments identified on low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline

Pi10 at Baseline is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of Pi10 at Month 30

Pi10 at Month 30 is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline

Perc15 in residual volume (RV) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Perc15 in Residual Volume at Month 30

Perc15 in residual volume (RV) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Month 30.

Time frame: At Month 30

Sub-cohort: Perc15 in Total Lung Capacity at Baseline

Perc15 in total lung capacity (TLC) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Perc15 in Total Lung Capacity at Month 30

Perc15 in total lung capacity (TLC) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Month 30.

Time frame: At Month 30

Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline

LAA-950 at Baseline is percentage (%) of voxels with attenuation less than or equal to (\<=)-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of LAA-950 at Month 30

LAA-950 at Month 30 is percentage (%) of voxels with attenuation \<=-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Month 30.

Time frame: At Month 30

Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline

Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30

Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Week 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping.

Time frame: At Month 30

Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline

Percentage of whole lung associated with emphysema as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30

Percentage of whole lung associated with emphysema as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema.

Time frame: At Month 30

Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline

Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30

Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue.

Time frame: At Month 30

Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline

Air volume ratio at Baseline is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.

Time frame: Baseline (Day 1 of Month 1)

Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30

Air volume ratio at Month 30 is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Month 30.

Time frame: At Month 30