Trial Outcomes & Findings for A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT05169424)
NCT ID: NCT05169424
Last Updated: 2023-10-19
Results Overview
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
COMPLETED
9117 participants
From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.
2023-10-19
Participant Flow
This was a non-interventional, observational, retrospective study using existing real-world data, investigating the risk of Chronic obstructive pulmonary disease (COPD) exacerbations, community acquired pneumonia, and health care utilization in maintenance treatment naive patients treated as first line therapy with Stiolto, in comparison to Trelegy.
All subjects who strictly met all inclusion and none of the exclusion criteria were included.
Participant milestones
| Measure |
Stiolto Initiators
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Overall Study
STARTED
|
3996
|
5121
|
|
Overall Study
Propensity Score Matching
|
2951
|
2951
|
|
Overall Study
COMPLETED
|
3996
|
5121
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stiolto Initiators
n=3996 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=5121 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Total
n=9117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 8.37 • n=3996 Participants
|
60.9 Years
STANDARD_DEVIATION 78.7 • n=5121 Participants
|
61.25 Years
STANDARD_DEVIATION 8.10 • n=9117 Participants
|
|
Sex: Female, Male
Female
|
1894 Participants
n=3996 Participants
|
2368 Participants
n=5121 Participants
|
4262 Participants
n=9117 Participants
|
|
Sex: Female, Male
Male
|
2102 Participants
n=3996 Participants
|
2753 Participants
n=5121 Participants
|
4855 Participants
n=9117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry
|
0.28 exacerbation per patient-year
|
0.32 exacerbation per patient-year
|
PRIMARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had no baseline exacerbation were included in the analysis.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2128 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2114 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation
|
0.25 exacerbation per patient-year
|
0.3 exacerbation per patient-year
|
PRIMARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subject who had 0 or 1 baseline exacerbation were included in the analysis.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2852 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2829 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation
|
0.27 exacerbation per patient-year
|
0.31 exacerbation per patient-year
|
PRIMARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only subjects with 2 or more baseline exacerbations were included in the analysis.
Incidence rate of chronic obstructive pulmonary disease (COPD) exacerbation after cohort entry among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of exacerbation for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=99 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=122 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations
|
0.49 exacerbation per patient-year
|
0.58 exacerbation per patient-year
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position)
|
0.025 pneu. hospitalization per patient-year
|
0.030 pneu. hospitalization per patient-year
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with no baseline exacerbation were included.
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with no baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2128 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2114 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation
|
0.024 pneu. hospitalization per patient-year
|
0.023 pneu. hospitalization per patient-year
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 0 or 1 baseline exacerbation were included.
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 0 or 1 baseline exacerbation were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2852 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2829 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation
|
0.024 pneu. hospitalization per patient-year
|
0.028 pneu. hospitalization per patient-year
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort. Only participants with 2 or more baseline exacerbations were included.
The incidence rates of pneumonia (pneu.) hospitalization (diagnosis in any position) among patients with 2 or more baseline exacerbations were reported. The incidence rate was calculated as totaling the number of pneumonia hospitalization for all patients / total follow-up in days \* 365.
Outcome measures
| Measure |
Stiolto Initiators
n=99 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=122 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations
|
0.075 pneu. hospitalization per patient-year
|
0.072 pneu. hospitalization per patient-year
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The total annualized costs of COPD or pneumonia-related health care cost and resource utilization (HCRU) were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU)
|
9834 dollars per year
Interval 8413.0 to 11256.0
|
10020 dollars per year
Interval 8216.0 to 11824.0
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The total annualized costs of COPD-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Total Costs of COPD-related HCRU
|
9688 dollars per year
Interval 8271.0 to 11105.0
|
9834 dollars per year
Interval 8038.0 to 11630.0
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The total annualized costs of pneumonia-related HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Total Costs of Pneumonia-related HCRU
|
2244 dollars per year
Interval 1406.0 to 3082.0
|
2274 dollars per year
Interval 676.0 to 3872.0
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The total annualized costs of COPD or pneumonia attributable HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Total Costs of COPD or Pneumonia Attributable HCRU
|
5729 dollars per year
Interval 4565.0 to 6894.0
|
5409 dollars per year
Interval 4808.0 to 6009.0
|
SECONDARY outcome
Timeframe: From index date (i.e. baseline, cohort entry, 15 September 2017) until 31st March 2020, up to 30 months and 16 days.Population: Only subjects who strictly met all inclusion and none of the exclusion criteria and who were included in the propensity score matched cohort.
The total annualized costs of all-cause HCRU were calculated for each cohort by totaling the costs for all patients divided by the total follow-up in days, multiplied by 365.
Outcome measures
| Measure |
Stiolto Initiators
n=2951 Participants
Chronic obstructive pulmonary disease (COPD) patients who initiated with Stiolto Respimat (Tiotropium + Olodaterol (5/5 micrograms (mcg)) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
Trelegy Initiators
n=2951 Participants
COPD patients who initiated with Trelegy Ellipta (Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg) in the existing real-world data from the Commercial Insurance and Medicare beneficiaries data using administrative claims between 15 September 2016 and 31st March 2020.
All participants had enrolled 1 year before the index date (starting from 15 September 2017).
|
|---|---|---|
|
Total Costs of All-cause HCRU
|
20849 dollars per year
Interval 18803.0 to 22896.0
|
19384 dollars per year
Interval 17282.0 to 21487.0
|
Adverse Events
Stiolto Initiators
Trelegy Initiators
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER