Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004768-72 | EudraCT Number |
Not provided
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Due to a change in the development program, the study was closed prematurely.
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The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.
The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.
With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Experimental | Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg |
|
| Vilaprisan (BAY1002670) 4 mg | Experimental | Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg |
|
| Placebo group | Placebo Comparator | Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | Intake orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding | Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' on bleeding/non-bleeding days was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Dr. James A. Simon, MD | Washington D.C. | District of Columbia | 20036 | United States | ||
| Helix Biomedics, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38983729 | Derived | Taylor HS, Dong L, Haikonen J, Oppelt P, Tamussino K, Wenzl R, Faustmann T, Groettrup-Wolfers E, Ren X, Seitz C. Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial. F S Rep. 2024 Mar 11;5(2):189-196. doi: 10.1016/j.xfre.2024.03.002. eCollection 2024 Jun. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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With the implementation of protocol version 4.0 dated 11-Dec-2018, no new participants were enrolled. The objectives of this study cannot be reached as only limited data is available from participants recruited before the treatment stopped. Overall, 48 participants were screened, of whom 8 participants were randomized and received the study treatment.
Study was conducted at 7 study centers worldwide, between 04-Jul-2018 (first participant first visit) and 26-Nov-2020 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vilaprisan (BAY1002670) 2 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg. |
| FG001 | Vilaprisan (BAY1002670) 4 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg |
| 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 | Feb 17, 2020 | Dec 18, 2020 |
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| Matching Placebo | Drug | Intake orally, once daily |
|
| Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
| Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
| Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
| The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study. | Up to 6 months |
| Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps | Up to 6 months |
| Number of Participants With Clinical Significant Abnormal Ultrasound Examinations | Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study. | Up to 6 months |
| Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements | A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed. | Up to 6 months |
| Number of Participants With Clinical Significant Abnormal Laboratory Values | Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins. | Up to 6 months |
| Boynton Beach |
| Florida |
| 33435 |
| United States |
| Solutions Through Advanced Research, Inc. | Jacksonville | Florida | 32256 | United States |
| Southern Clinical Research Associates LLC | Metairie | Louisiana | 70001 | United States |
| Unified Women's Clinical Research - Morehead City | Morehead City | North Carolina | 28557 | United States |
| Unified Women's Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Medizinische Universität Graz | Graz | Styria | 8036 | Austria |
| Kepler Universitätsklinikum Campus IV | Linz | Upper Austria | 4020 | Austria |
| Universitätsklinikum AKH Wien | Vienna | 1090 | Austria |
| KABEG Landeskrankenhaus Villach | Villach | 9500 | Austria |
| Queen's University | Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa Hospital-Riverside Campus | Ottawa | Ontario | K1H 7W9 | Canada |
| Clinique OVO | Montreal | Quebec | H4P 2S4 | Canada |
| Gynekologie MEDA s.r.o. | Brno | 602 00 | Czechia |
| GynCare MUDr. Michael Svec s.r.o. | Pilsen | 326 00 | Czechia |
| VL-Medi Oy | Helsinki | 00510 | Finland |
| Satakunnan keskussairaala | Pori | 28500 | Finland |
| A.O.U.I. Verona | Verona | Veneto | 37126 | Italy |
| Tokeidai Memorial Clinic | Sapporo | Hokkaido | 060-0031 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | 861-8520 | Japan |
| Toyama Prefectural Central Hospital | Toyama | 930-8550 | Japan |
| Centrum Medyczne Chodzki | Lublin | 20-093 | Poland |
| FG002 | Placebo | Premenopausal women 18 years and older with endometriosis received placebo. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vilaprisan (BAY1002670) 2 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg. |
| BG001 | Vilaprisan (BAY1002670) 4 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg |
| BG002 | Placebo | Premenopausal women 18 years and older with endometriosis received placebo. |
| BG003 | 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 |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) | Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Posted | Mean | Full Range | Scores on a scale | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding | Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' on bleeding/non-bleeding days was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Posted | Mean | Full Range | Scores on a scale | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Posted | Mean | Full Range | Tablets | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) | Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed. | Posted | Mean | Full Range | Tablets | Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study. | Posted | Count of Participants | Participants | Up to 6 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings | Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps | Posted | Count of Participants | Participants | Up to 6 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Significant Abnormal Ultrasound Examinations | Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study. | Posted | Count of Participants | Participants | Up to 6 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements | A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed. | Posted | Count of Participants | Participants | Up to 6 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Significant Abnormal Laboratory Values | Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins. | Posted | Count of Participants | Participants | Up to 6 months |
|
|
Adverse event data were collected from first study medication intake until last visit of the subject (516 days on average).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Premenopausal women 18 years and older with endometriosis received placebo | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Vilaprisan (BAY1002670) 2 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 2 mg. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Vilaprisan (BAY1002670) 4 mg | Premenopausal women 18 years and older with endometriosis received the treatment of Vilaprisan 4 mg | 0 | 4 | 3 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Endometriosis ablation | Surgical and medical procedures | MedDRA (22.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Cortisol increased | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (22.1) | Non-systematic Assessment |
|
No inferential statistical analysis was performed due to a small population.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2020 | Dec 18, 2020 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C586669 | vilaprisan |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Premenopausal women 18 years and older with endometriosis received placebo.
|
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| Participants |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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