Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01760954
• Collaborator: (none)
• Enrollment: 506
• Arms: 2
• Actual Duration (Months): 39.6

Study Details

Study Description

Brief Summary

A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Elagolix	Phase 3

Detailed Description

This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 506 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
• Actual Study Start Date: Dec 28, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Apr 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elagolix 150 mg QD Participants received elagolix 150 mg tablets once a day (QD) for 6 months.	Drug: Elagolix; Elagolix tablets administered orally; Other Names: Orilissa™
Experimental: Elagolix 200 mg BID Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.	Drug: Elagolix; Elagolix tablets administered orally; Other Names: Orilissa™

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6]

   Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.

2. Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6]

   Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.

Secondary Outcome Measures

1. Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5]

   Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. Dysmenorrhea was assessed according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.

2. Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5]

   Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.

3. Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Response was defined as a reduction of -0.36 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesics). Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

4. Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.

5. Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.

6. Percent Change From Baseline in Dyspareunia Based on Daily Assessment [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Participants assessed dyspareunia each day in an e-Diary according to the following response options: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

7. Change From Baseline in Any Rescue Analgesic Use [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.

8. Change From Baseline in NSAID Rescue Analgesic Use [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.

9. Change From Baseline in Opioid Rescue Analgesic Use [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

   Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.

10. Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6]

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.

11. Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved [Months 1, 2, 3, 4, 5, and 6]

    The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories: Very Much Improved Much Improved Minimally Improved Not Changed Minimally Worse Much Worse Very Much Worse

12. Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6]

    The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis. Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always. The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.

13. Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6]

    The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse [5 items]) was used in this study. The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.

14. Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household [Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6]

    The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home. Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments. Total hours lost is the sum of hours missed due to absenteeism plus presenteeism.

15. Number of Participants With Non-study Health Visits During the Treatment Period [6 months]

    The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study.

16. Number of Days in Hospital During the Treatment Period [6 months]

    The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)

• Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

• Clinically significant gynecological condition

• Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip

• Plans to become pregnant in the next 18 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

• Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160. doi: 10.1097/AOG.0000000000002675. Erratum in: Obstet Gynecol. 2018 Dec;132(6):1507-1508.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01760954
• Other Study ID Numbers: M12-667
• First Posted: Jan 4, 2013
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Endometriosis associated pain; Elagolix; Gonadotropin-Releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP)
• Additional relevant MeSH terms: Endometriosis

Study Results

Participant Flow

Recruitment Details	Participants who completed the 6-month Treatment Period in the pivotal Study M12-665 (NCT01620528) were eligible to enter this extension study. A total of 506 participants were enrolled at 131 sites in the United States, Puerto Rico, and Canada. Two enrolled participants did not receive study drug and are not included in the tables reported below.
Pre-assignment Detail	The study consisted of a 6-month Treatment Period and a Post-treatment Follow-up (PTFU) of up to 12 months. Participants who received elagolix in the pivotal study continued to receive the same dose for a further 6 months; participants on placebo in the pivotal study were randomized 1:1 to either elagolix 150 mg once daily or 200 mg twice daily.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Period Title: Treatment Period (6 Months)
STARTED	149	138	108	109
COMPLETED	116	110	87	83
NOT COMPLETED	33	28	21	26
Period Title: Treatment Period (6 Months)
STARTED	126	118	86	87
COMPLETED	96	83	65	67
NOT COMPLETED	30	35	21	20

Baseline Characteristics

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID	Total
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.	Total of all reporting groups
Overall Participants	149	138	108	109	504
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.8 (6.52)	31.3 (6.32)	32.4 (6.08)	32.2 (6.38)	31.9 (6.34)
Sex: Female, Male (Count of Participants)
Female	149 100%	138 100%	108 100%	109 100%	504 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	23 15.4%	21 15.2%	19 17.6%	22 20.2%	85 16.9%
Not Hispanic or Latino	126 84.6%	117 84.8%	89 82.4%	87 79.8%	419 83.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	133 89.3%	126 91.3%	96 88.9%	95 87.2%	450 89.3%
Black or African American	12 8.1%	9 6.5%	8 7.4%	12 11%	41 8.1%
Asian	2 1.3%	0 0%	0 0%	0 0%	2 0.4%
American Indian/Alaska Native	1 0.7%	0 0%	1 0.9%	0 0%	2 0.4%
Multi race	1 0.7%	3 2.2%	3 2.8%	1 0.9%	8 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	1 0.9%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Description	Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	117	110	86	87
Number [percentage of participants]	52.1 35%	78.2 56.7%	32.6 30.2%	64.4 59.1%

2. Primary Outcome

Title	Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Description	Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	117	110	86	87
Number [percentage of participants]	67.5 45.3%	69.1 50.1%	39.5 36.6%	57.5 52.8%

3. Secondary Outcome

Title	Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment
Description	Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. Dysmenorrhea was assessed according to the following: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	108	109
Month 1	48.0 32.2%	80.9 58.6%	21.0 19.4%	20.6 18.9%
Month 2	51.1 34.3%	78.9 57.2%	40.2 37.2%	60.0 55%
Month 3	49.2 33%	80.5 58.3%	36.8 34.1%	54.3 49.8%
Month 4	53.9 36.2%	79.8 57.8%	39.6 36.7%	58.2 53.4%
Month 5	54.0 36.2%	83.3 60.4%	32.6 30.2%	64.0 58.7%

4. Secondary Outcome

Title	Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment
Description	Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	108	109
Month 1	55.4 37.2%	74.3 53.8%	23.8 22%	29.0 26.6%
Month 2	62.6 42%	69.5 50.4%	38.1 35.3%	41.0 37.6%
Month 3	61.4 41.2%	70.7 51.2%	33.7 31.2%	45.7 41.9%
Month 4	64.1 43%	75.6 54.8%	39.6 36.7%	47.3 43.4%
Month 5	61.3 41.1%	71.9 52.1%	40.4 37.4%	51.7 47.4%

5. Secondary Outcome

Title	Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment
Description	Response was defined as a reduction of -0.36 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesics). Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point; if a participant's mean score was not defined because all reports in that month were "Not Applicable," then that mean score was treated as missing.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	108	109
Month 1	50.0 33.6%	61.3 44.4%	33.3 30.8%	15.6 14.3%
Month 2	51.9 34.8%	58.3 42.2%	35.8 33.1%	30.0 27.5%
Month 3	50.0 33.6%	63.8 46.2%	36.4 33.7%	32.8 30.1%
Month 4	48.9 32.8%	65.3 47.3%	46.9 43.4%	41.9 38.4%
Month 5	46.6 31.3%	65.3 47.3%	38.1 35.3%	39.7 36.4%
Month 6	45.2 30.3%	60.0 43.5%	39.0 36.1%	43.1 39.5%

6. Secondary Outcome

Title	Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment
Description	Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-46.7 (44.00)	-82.7 (34.81)	-19.0 (50.35)	-19.3 (51.09)
Month 2	-46.7 (44.93)	-84.8 (29.81)	-46.6 (47.39)	-67.3 (47.74)
Month 3	-47.9 (42.37)	-84.5 (33.24)	-36.3 (57.28)	-65.9 (47.17)
Month 4	-51.4 (44.65)	-85.1 (30.52)	-38.2 (52.48)	-67.4 (47.80)
Month 5	-52.4 (43.55)	-83.4 (31.19)	-33.4 (48.29)	-77.2 (41.90)
Month 6	-49.2 (43.75)	-82.0 (33.29)	-37.9 (47.43)	-71.6 (47.81)

7. Secondary Outcome

Title	Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment
Description	Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: 0: No discomfort 1: Mild discomfort but I was easily able to do the things I usually do 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-37.4 (43.90)	-54.5 (40.35)	-9.6 (104.61)	-20.7 (51.24)
Month 2	-41.4 (41.49)	-56.4 (38.54)	-22.6 (85.60)	-18.0 (98.73)
Month 3	-44.0 (40.44)	-56.8 (39.14)	-19.7 (93.18)	-30.2 (57.07)
Month 4	-47.2 (41.30)	-59.6 (37.30)	-32.0 (66.23)	-33.9 (53.27)
Month 5	-45.3 (41.05)	-58.0 (39.18)	-17.7 (126.45)	-42.5 (43.01)
Month 6	-48.9 (41.69)	-56.5 (40.15)	-10.2 (163.42)	-43.9 (43.57)

8. Secondary Outcome

Title	Percent Change From Baseline in Dyspareunia Based on Daily Assessment
Description	Participants assessed dyspareunia each day in an e-Diary according to the following response options: 0: None; No discomfort during sexual intercourse 1: Mild; Able to tolerate the discomfort during sexual intercourse 2: Moderate; Intercourse was interrupted due to pain 3: Severe; Avoided intercourse because of pain Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point; participants with responses of 'Not Applicable' on all reported days during baseline or for the entire time point were excluded from the analysis.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	123	109	85	82
Month 1	-32.8 (63.13)	-39.5 (71.30)	-12.9 (62.92)	-1.1 (63.74)
Month 2	-36.2 (56.97)	-40.4 (63.27)	-16.2 (82.49)	-27.1 (48.17)
Month 3	-36.1 (55.41)	-38.6 (75.34)	-14.1 (76.54)	-23.5 (50.71)
Month 4	-35.0 (55.27)	-48.6 (63.81)	-24.3 (76.26)	-20.7 (71.89)
Month 5	-34.9 (58.90)	-44.8 (76.01)	-20.2 (62.92)	-27.5 (58.78)
Month 6	-30.7 (66.57)	-41.7 (68.50)	-28.0 (66.59)	-12.6 (107.83)

9. Secondary Outcome

Title	Change From Baseline in Any Rescue Analgesic Use
Description	Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-0.35 (0.743)	-0.58 (0.687)	-0.15 (0.398)	-0.16 (0.486)
Month 2	-0.35 (0.646)	-0.59 (0.735)	-0.24 (0.471)	-0.28 (0.481)
Month 3	-0.37 (0.733)	-0.61 (0.785)	-0.25 (0.525)	-0.32 (0.470)
Month 4	-0.40 (0.703)	-0.62 (0.697)	-0.26 (0.521)	-0.35 (0.616)
Month 5	-0.41 (0.687)	-0.59 (0.685)	-0.27 (0.626)	-0.34 (0.590)
Month 6	-0.40 (0.699)	-0.56 (0.667)	-0.22 (0.616)	-0.38 (0.602)

10. Secondary Outcome

Title	Change From Baseline in NSAID Rescue Analgesic Use
Description	Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-0.24 (0.484)	-0.34 (0.469)	-0.07 (0.217)	-0.09 (0.314)
Month 2	-0.24 (0.472)	-0.34 (0.462)	-0.12 (0.302)	-0.14 (0.311)
Month 3	-0.24 (0.488)	-0.34 (0.460)	-0.12 (0.324)	-0.14 (0.346)
Month 4	-0.25 (0.461)	-0.35 (0.450)	-0.13 (0.336)	-0.17 (0.397)
Month 5	-0.27 (0.494)	-0.32 (0.417)	-0.13 (0.378)	-0.17 (0.394)
Month 6	-0.27 (0.517)	-0.31 (0.430)	-0.12 (0.380)	-0.23 (0.453)

11. Secondary Outcome

Title	Change From Baseline in Opioid Rescue Analgesic Use
Description	Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-0.11 (0.547)	-0.24 (0.469)	-0.09 (0.272)	-0.07 (0.329)
Month 2	-0.11 (0.441)	-0.25 (0.532)	-0.12 (0.267)	-0.14 (0.344)
Month 3	-0.13 (0.540)	-0.28 (0.599)	-0.13 (0.298)	-0.17 (0.338)
Month 4	-0.15 (0.541)	-0.27 (0.581)	-0.13 (0.298)	-0.19 (0.501)
Month 5	-0.15 (0.469)	-0.27 (0.558)	-0.14 (0.384)	-0.17 (0.444)
Month 6	-0.13 (0.439)	-0.25 (0.534)	-0.10 (0.369)	-0.16 (0.392)

12. Secondary Outcome

Title	Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)
Description	The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	107	107
Month 1	-41.0 (39.85)	-60.0 (36.93)	-9.2 (81.63)	-22.3 (34.41)
Month 2	-44.4 (38.35)	-62.1 (33.80)	-31.2 (39.22)	-34.6 (41.07)
Month 3	-45.5 (36.23)	-62.2 (34.10)	-28.0 (55.94)	-39.9 (41.48)
Month 4	-47.7 (37.99)	-63.5 (32.93)	-32.8 (57.74)	-40.0 (54.65)
Month 5	-46.4 (38.07)	-62.1 (34.56)	-29.0 (71.65)	-46.4 (39.07)
Month 6	-48.2 (38.97)	-60.7 (36.09)	-27.8 (64.75)	-45.5 (44.10)

13. Secondary Outcome

Title	Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
Description	The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories: Very Much Improved Much Improved Minimally Improved Not Changed Minimally Worse Much Worse Very Much Worse
Time Frame	Months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	148	108	109
Month 1	63.3 42.5%	86.4 62.6%	47.1 43.6%	45.5 41.7%
Month 2	64.7 43.4%	87.3 63.3%	65.7 60.8%	70.0 64.2%
Month 3	64.3 43.2%	87.4 63.3%	73.7 68.2%	71.3 65.4%
Month 4	70.7 47.4%	91.5 66.3%	73.9 68.4%	70.8 65%
Month 5	75.2 50.5%	87.5 63.4%	66.3 61.4%	78.7 72.2%
Month 6	69.4 46.6%	91.2 66.1%	70.4 65.2%	79.3 72.8%

14. Secondary Outcome

Title	Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension
Description	The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis. Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always. The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	135	108	109
Month 1	-29.50 (20.917)	-40.28 (21.503)	-12.98 (17.426)	-13.27 (17.010)
Month 3	-30.10 (20.231)	-43.16 (20.951)	-17.87 (21.160)	-21.87 (24.087)
Month 6	-31.18 (22.213)	-41.62 (21.553)	-15.63 (22.676)	-25.17 (23.387)

15. Secondary Outcome

Title	Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension
Description	The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse [5 items]) was used in this study. The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	120	102	97	95
Month 1	-19.81 (23.828)	-29.42 (28.257)	-8.15 (21.287)	-9.86 (17.484)
Month 3	-20.88 (24.979)	-27.27 (30.431)	-15.00 (22.890)	-18.24 (23.015)
Month 6	-24.23 (27.065)	-30.55 (33.831)	-12.45 (26.858)	-23.17 (25.763)

16. Secondary Outcome

Title	Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household
Description	The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home. Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments. Total hours lost is the sum of hours missed due to absenteeism plus presenteeism.
Time Frame	Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point. Hours lost from workplace were only calculated for participants who were employed.

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	140	135	102	106
Absenteeism from workplace	-1.84 (5.636)	-3.01 (6.771)	-2.15 (4.258)	-2.78 (4.730)
Presenteeism from workplace	-11.14 (8.484)	-12.45 (10.464)	-8.29 (8.307)	-10.15 (10.724)
Total hours of work lost from workplace	-12.98 (9.662)	-15.15 (11.653)	-10.44 (9.422)	-13.03 (11.911)
Absenteeism from household	-3.10 (7.588)	-3.69 (4.486)	-3.76 (7.457)	-2.80 (4.971)
Presenteeism from household	-2.72 (6.459)	-2.49 (4.531)	-2.95 (4.793)	-2.72 (4.698)
Total hours of work lost from household	-5.82 (11.356)	-6.15 (7.628)	-6.90 (11.673)	-5.52 (6.934)

17. Secondary Outcome

Title	Number of Participants With Non-study Health Visits During the Treatment Period
Description	The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	149	138	108	109
Count of Participants [Participants]	81 54.4%	68 49.3%	59 54.6%	48 44%

18. Secondary Outcome

Title	Number of Days in Hospital During the Treatment Period
Description	The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of double-blind study drug in this extension study and who underwent hospitalization

Arm/Group Title	Elagolix/Elagolix 150 mg QD	Elagolix/Elagolix 200 mg BID	Placebo/Elagolix 150 mg QD	Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.	Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Measure Participants	7	6	5	4
Median (Full Range) [days]	2.0	1.5	3.0	1.0

Adverse Events

Time Frame	From the date of the first dose of study drug in Study M12-667 through up to 30 days after the last dose of study drug (up to 7 months).
Arm/Group Title	Elagolix/Elagolix 150 mg QD		Elagolix/Elagolix 200 mg BID		Placebo/Elagolix 150 mg QD		Placebo/Elagolix 200 mg BID
Arm/Group Description	Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.		Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.		Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.		Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
All Cause Mortality
	Elagolix/Elagolix 150 mg QD		Elagolix/Elagolix 200 mg BID		Placebo/Elagolix 150 mg QD		Placebo/Elagolix 200 mg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/149 (0%)		0/138 (0%)		0/108 (0%)		0/109 (0%)
Serious Adverse Events
	Elagolix/Elagolix 150 mg QD		Elagolix/Elagolix 200 mg BID		Placebo/Elagolix 150 mg QD		Placebo/Elagolix 200 mg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/149 (3.4%)		4/138 (2.9%)		5/108 (4.6%)		5/109 (4.6%)
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	0/109 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN UPPER	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
COLITIS	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	0/109 (0%)	0
GASTROINTESTINAL HAEMORRHAGE	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
INCARCERATED UMBILICAL HERNIA	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	0/109 (0%)	0
NAUSEA	0/149 (0%)	0	0/138 (0%)	0	0/108 (0%)	0	1/109 (0.9%)	1
VOMITING	0/149 (0%)	0	0/138 (0%)	0	0/108 (0%)	0	1/109 (0.9%)	1
Hepatobiliary disorders
CHOLELITHIASIS	0/149 (0%)	0	0/138 (0%)	0	0/108 (0%)	0	1/109 (0.9%)	1
Infections and infestations
DIVERTICULITIS	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
Injury, poisoning and procedural complications
JOINT INJURY	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
NECK PAIN	0/149 (0%)	0	1/138 (0.7%)	1	0/108 (0%)	0	0/109 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	0/109 (0%)	0
Nervous system disorders
MIGRAINE	0/149 (0%)	0	1/138 (0.7%)	1	0/108 (0%)	0	0/109 (0%)	0
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS	0/149 (0%)	0	0/138 (0%)	0	0/108 (0%)	0	1/109 (0.9%)	1
Psychiatric disorders
AFFECTIVE DISORDER	0/149 (0%)	0	1/138 (0.7%)	1	0/108 (0%)	0	0/109 (0%)	0
SUICIDAL IDEATION	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
Reproductive system and breast disorders
OVARIAN CYST	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	0/109 (0%)	0
PELVIC PAIN	0/149 (0%)	0	2/138 (1.4%)	2	0/108 (0%)	0	2/109 (1.8%)	2
PREMENSTRUAL DYSPHORIC DISORDER	1/149 (0.7%)	1	0/138 (0%)	0	0/108 (0%)	0	0/109 (0%)	0
Surgical and medical procedures
ABORTION INDUCED	0/149 (0%)	0	0/138 (0%)	0	1/108 (0.9%)	1	1/109 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Elagolix/Elagolix 150 mg QD		Elagolix/Elagolix 200 mg BID		Placebo/Elagolix 150 mg QD		Placebo/Elagolix 200 mg BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/149 (53%)		74/138 (53.6%)		55/108 (50.9%)		68/109 (62.4%)
Gastrointestinal disorders
ABDOMINAL PAIN	7/149 (4.7%)	7	8/138 (5.8%)	9	2/108 (1.9%)	3	1/109 (0.9%)	1
NAUSEA	7/149 (4.7%)	8	10/138 (7.2%)	12	6/108 (5.6%)	6	11/109 (10.1%)	12
General disorders
FATIGUE	9/149 (6%)	9	5/138 (3.6%)	5	3/108 (2.8%)	3	4/109 (3.7%)	4
Infections and infestations
BRONCHITIS	8/149 (5.4%)	8	7/138 (5.1%)	7	3/108 (2.8%)	3	3/109 (2.8%)	3
INFLUENZA	6/149 (4%)	6	6/138 (4.3%)	7	7/108 (6.5%)	7	1/109 (0.9%)	1
NASOPHARYNGITIS	9/149 (6%)	9	9/138 (6.5%)	11	5/108 (4.6%)	5	3/109 (2.8%)	3
SINUSITIS	10/149 (6.7%)	10	10/138 (7.2%)	11	6/108 (5.6%)	6	10/109 (9.2%)	10
UPPER RESPIRATORY TRACT INFECTION	16/149 (10.7%)	18	4/138 (2.9%)	4	5/108 (4.6%)	5	5/109 (4.6%)	5
URINARY TRACT INFECTION	17/149 (11.4%)	23	11/138 (8%)	12	10/108 (9.3%)	10	8/109 (7.3%)	9
VULVOVAGINAL MYCOTIC INFECTION	8/149 (5.4%)	10	6/138 (4.3%)	6	6/108 (5.6%)	7	3/109 (2.8%)	5
Investigations
BONE DENSITY DECREASED	2/149 (1.3%)	2	9/138 (6.5%)	9	2/108 (1.9%)	2	3/109 (2.8%)	3
C-REACTIVE PROTEIN INCREASED	3/149 (2%)	3	7/138 (5.1%)	7	3/108 (2.8%)	4	3/109 (2.8%)	4
Musculoskeletal and connective tissue disorders
ARTHRALGIA	2/149 (1.3%)	2	7/138 (5.1%)	7	2/108 (1.9%)	2	4/109 (3.7%)	5
BACK PAIN	6/149 (4%)	7	10/138 (7.2%)	11	3/108 (2.8%)	3	5/109 (4.6%)	5
Nervous system disorders
HEADACHE	10/149 (6.7%)	11	8/138 (5.8%)	11	10/108 (9.3%)	13	15/109 (13.8%)	20
Psychiatric disorders
ANXIETY	5/149 (3.4%)	5	2/138 (1.4%)	2	6/108 (5.6%)	6	3/109 (2.8%)	4
DEPRESSION	8/149 (5.4%)	8	4/138 (2.9%)	4	2/108 (1.9%)	2	0/109 (0%)	0
INSOMNIA	5/149 (3.4%)	5	5/138 (3.6%)	6	1/108 (0.9%)	1	6/109 (5.5%)	7
Vascular disorders
HOT FLUSH	6/149 (4%)	7	8/138 (5.8%)	8	18/108 (16.7%)	19	33/109 (30.3%)	38

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.