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This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Dentifrice1 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
|
| Experimental Dentifrice 2 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
|
| Experimental Dentifrice 3 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
|
| Reference Product 1 | Placebo Comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.425 % w/w phytate,1150ppm F | Drug | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100. | Baseline upto 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate | SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
A total of 58 participants were screened, of which 45 participants were randomized and 42 completed the study.
Participants were recruited at one center in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a single-centre, randomized, blinded (examiner and laboratory analyst), placebo-controlled, 6-treatment, 4-period cross-over, incomplete block design, in situ caries study in healthy adults who wore a removable bilateral mandibular partial denture. Each participant received Test Product 1 (Dentifrice containing 0.425 % weight by weight (w/w) phytate, and 1150 parts per million [ppm] fluoride [F]), Test Product 2 (Dentifrice containing 0.85 % w/w phytate, and 1150 ppm fluoride), Test Product 3 (Dentifrice containing 0.85 % w/w phytate, 0.3% zinc chloride, 0.5% sodium citrate, and 1150 ppm fluoride), Reference Product 1 (0 ppm fluoride), Reference Product 2 (Dentrifrice containing 1150 ppm fluoride toothpaste and Reference Product 3 (Dentrifrice containing 0.3% zinc chloride , 0.5% sodium citrate, and 1150 ppm fluoride). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were included for baseline evaluation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100. | Intent-to-treat (ITT) population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], Reference Product 1- [1], and Reference Product 2- [1]. | Posted | Mean | Standard Deviation | % SMHR | Baseline upto 2 weeks |
|
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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 | Test Product 1 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GINGIVAL ERYTHEMA | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077559 | Sodium Citrate |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
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|
| Reference Product 2 | Active Comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
|
| Reference Product 3 | Active Comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
|
| 0.85 % w/w phytate,1150ppm F | Drug | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F | Drug | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| 0 ppm F | Other | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| 1150ppm F | Drug | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F | Drug | Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. |
|
| Baseline upto 2 weeks |
| Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z). | Baseline upto 4 weeks |
| TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate | TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z). | Baseline upto 4 weeks |
| Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2. | At Week 2 |
| Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2. | At Week 4 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15 milliliters (ml) of tap water for approximately 10 seconds (s). |
| OG001 | Test Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned experimental dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute twice daily, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. |
| OG002 | Reference Product 1 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. |
| OG003 | Reference Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned reference dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. |
|
|
|
| Secondary | % SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate | SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100. | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2- [1], Test product 3- [2], Reference Product 2- [1], and Reference Product 3- [1]. | Posted | Mean | Standard Deviation | % SMHR | Baseline upto 2 weeks |
|
|
|
| Secondary | Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z). | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], and Reference Product 2- [1]. | Posted | Mean | Standard Deviation | [%vol mineral x µm | Baseline upto 4 weeks |
|
|
|
| Secondary | TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate | TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z). | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2 - [1], Test product 3 - [2], Reference Product 2 - [1] and Reference Product 3 [1]. | Posted | Mean | Standard Deviation | [%vol mineral x µm | Baseline upto 4 weeks |
|
|
|
| Secondary | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2. | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[1], Test product3-[2], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1]. | Posted | Mean | Standard Deviation | μg/cm^2 | At Week 2 |
|
|
|
| Secondary | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2. | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[2], Test product3-[3], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1]. | Posted | Mean | Standard Deviation | μg/cm^2 | At Week 4 |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 9 |
| 28 |
| EG001 | Test Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | 28 | 0 | 28 | 9 | 28 |
| EG002 | Test Product 3 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s | 0 | 28 | 0 | 28 | 10 | 28 |
| EG003 | Reference Product 1 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | 29 | 0 | 29 | 7 | 29 |
| EG004 | Reference Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | 27 | 0 | 27 | 4 | 27 |
| EG005 | Reference Product 3 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | 28 | 0 | 28 | 8 | 28 |
| Mouth ulceration | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Gingival ulceration | Gastrointestinal disorders |
|
| Oral mucosal erythema | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders |
|
| Gingival oedema | Gastrointestinal disorders |
|
| Gingival pain | Gastrointestinal disorders |
|
| Gingival swelling | Gastrointestinal disorders |
|
| Leukoplakia oral | Gastrointestinal disorders |
|
| Lip dry | Gastrointestinal disorders |
|
| Noninfective gingivitis | Gastrointestinal disorders |
|
| Tongue coated | Gastrointestinal disorders |
|
| Tongue oedema | Gastrointestinal disorders |
|
| Thermal burn | Injury, poisoning and procedural complications |
|
| Laceration | Injury, poisoning and procedural complications |
|
| Lip injury | Injury, poisoning and procedural complications |
|
| Muscle strain | Injury, poisoning and procedural complications |
|
| Traumatic ulcer | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Migraine | Nervous system disorders |
|
| Device Failure | Product Issues |
|
| Injury Associated With Device | General disorders |
|
| Seasonal Allergy | Immune system disorders |
|
| Angular cheilitis | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Oral herpes | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Glucose Tolerance Impaired | Metabolism and nutrition disorders |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders |
|
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |