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| ID | Type | Description | Link |
|---|---|---|---|
| H0P-MC-NP02 | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3526318 | Experimental | Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period. |
|
| Placebo | Placebo Comparator | Participants received placebo orally, once daily, for 8-weeks treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3526318 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research US, Inc. | Chandler | Arizona | 85224 | United States | ||
| Synexus Clinical Research - Glendale |
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| Label | URL |
|---|---|
| Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 250 Milligram (mg) LY3526318 | Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2021 | Sep 7, 2023 |
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| Drug |
Administered orally |
|
| Baseline, Week 4 |
| Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Week 4 |
| Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Week 8 |
| Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 4 |
| Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | Baseline, Week 8 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Arizona Research Center | Phoenix | Arizona | 85053 | United States |
| Alliance for Multispecialty Research, LLC Tempe | Tempe | Arizona | 85281 | United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| CMR of Greater New Haven | Hamden | Connecticut | 06517 | United States |
| VIN-Julie Schwartzbard | Aventura | Florida | 33180 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| University of Miami Don Suffer Clinical Research Building | Miami | Florida | 33136 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Synexus Clinical Research US, Inc - Orlando | Orlando | Florida | 32806 | United States |
| Synexus Clinical Research US, Inc. | Pinellas Park | Florida | 33781 | United States |
| Synexus Clinical Research US, Inc - Orlando | The Villages | Florida | 32162 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Synexus Clinical Research US, Inc. | Chicago | Illinois | 60602 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| Synexus - Cincinnati | Cincinnati | Ohio | 45236 | United States |
| META Medical Research Institute | Dayton | Ohio | 45432 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| Cedar Health Research | Dallas | Texas | 75251 | United States |
| Synexus - US | San Antonio | Texas | 78229 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
Participants received placebo orally, once daily, for 8-weeks treatment period.
| Received at Least One Dose of Study Drug (Safety Population Week 1-4) |
|
| Safety Population Week 5-8 | All participants who took at least 1 dose of study drug and who did not discontinue at or prior to week 4. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 250 mg LY3526318 | Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period. |
| BG001 | Placebo | Participants received placebo orally, once daily, for 8-weeks treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Primary | Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
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| Secondary | Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | hours per night | Baseline, Week 4 |
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| Secondary | Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | hours per night | Baseline, Week 8 |
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| Secondary | Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | mg per day (mg/day) | Week 4 |
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| Secondary | Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | mg/day | Week 8 |
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| Secondary | Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval. | All enrolled participants who took at least 1 dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 8 |
|
Baseline through Week 8
All participants under the safety population for week 1-4 and week 5-8.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 250 mg LY3526318 Week 1-4 | Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period (Week 1-4). | 0 | 102 | 2 | 102 | 40 | 102 |
| EG001 | 250 mg LY3526318/Placebo Week 5-8 | Participants who received 250 mg of LY3526318 in the first 4 weeks were switched to received placebo once daily for the next 4 weeks of the treatment period (Week 5-8). | 0 | 95 | 3 | 95 | 23 | 95 |
| EG002 | Placebo Week 1-4 | Participants received placebo orally, once daily, for week 1 to 4 of treatment period. | 0 | 52 | 1 | 52 | 22 | 52 |
| EG003 | Placebo Week 5-8 | Participant from Week 1-4 continued to receive placebo orally, once daily, for week 5 to 8 of treatment period. | 0 | 46 | 1 | 46 | 10 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Medical device site irritation | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 25.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Electrocardiogram ST-T change | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Lymphocyte count | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 25.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Poor quality sleep | Psychiatric disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA version 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2022 | Sep 7, 2023 | SAP_001.pdf |
Not provided
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Participants |
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| Participants |
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Participants received placebo orally, once daily, for 8-weeks treatment period. |
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Participants received placebo orally, once daily, for 8-weeks treatment period. |
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Participants received placebo orally, once daily, for 8-weeks treatment period. |
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Participants received placebo orally, once daily, for 8-weeks treatment period. |
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