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This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin (Lyrica) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin (Lyrica) | Drug | Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. | Up to 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Yotukaidou | Chiba | Japan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants received the study drug in the precedent study A0081208 (NCT00830167).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night. | Week 52 or Study Discontinuation |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. | Baseline, Week 52 or Study Discontinuation |
| Matuyama-si |
| Ehime |
| Japan |
| Pfizer Investigational Site | Iiduka | Fukuoka | Japan |
| Pfizer Investigational Site | Kobe | Hyōgo | Japan |
| Pfizer Investigational Site | Mito | Ibaraki | Japan |
| Pfizer Investigational Site | Morioka | Iwate | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Tsu | Mie-ken | Japan |
| Pfizer Investigational Site | Sendai | Miyagi | Japan |
| Pfizer Investigational Site | Hiki-gun | Saitama | Japan |
| Pfizer Investigational Site | Saitama-shi | Saitama | Japan |
| Pfizer Investigational Site | Shimotsuga-gun | Tochigi | Japan |
| Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan |
| Pfizer Investigational Site | Itabashi-Ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinagawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Nagano | Japan |
| Pfizer Investigational Site | Osaka | Japan |
| Pfizer Investigational Site | Ōita | Japan |
| Pfizer Investigational Site | Yokohama | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. | All participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Up to 53 weeks |
|
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| Secondary | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. | All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | mm | Baseline, Week 52 or Study Discontinuation |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | hours | Baseline, Week 52 or Study Discontinuation |
|
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| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
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| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
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| Secondary | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Number | Paticipants | Week 52 or Study Discontinuation |
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| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
|
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| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 52 or Study Discontinuation |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Pregabalin | Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account. | 3 | 106 | 92 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Crush Injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Compartment Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Title | Measurements |
|---|---|
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| >= 65 years |
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