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The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepreve | Experimental | Bepotastine Besilate Ophthalmic Solution 1.5% |
|
| Placebo | Placebo Comparator | sterile ophthalmic solution |
|
| Bepotastine Besilate | Experimental | sterile ophthalmic solution 1.0% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepreve | Drug | sterile ophthalmic solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Conjunctival Redness | Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness | Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Williams, PhD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22991696 | Derived | Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012 May-Jun;33(3):265-74. doi: 10.2500/aap.2012.33.3570. | |
| 20642205 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| FG001 | Placebo | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| FG002 | Bepotastine Besilate Ophthalmic Solution 1.0% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Ocular Itching | Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub | Posted | Mean | Standard Deviation | Units on a scale | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
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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 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Taste | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research & Medical Affairs | ISTA Pharmaceuticals, Inc. | 949-788-6000 | tmcnamara@istavision.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
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| Drug |
sterile ophthalmic solution |
|
| Bepotastine Besilate | Drug | sterile ophthalmic solution |
|
| 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Episcleral Redness | Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Chemosis | Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva | 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Rhinorrhea (Runny Nose) | Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Nasal Pruritus (Itchy Nose) | Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Ear or Palate Pruritus (Itchy Ear or Palate) | Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Nasal Congestion | Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model |
| Tearing | Percent of Eyes with Tearing. Scored as absent or present | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Ocular Mucus Discharge | Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Eyelid Swelling | Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Total Nasal Symptom | Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
| Torkildsen GL, Williams JI, Gow JA, Gomes PJ, Abelson MB, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution for the relief of nonocular symptoms provoked by conjunctival allergen challenge. Ann Allergy Asthma Immunol. 2010 Jul;105(1):57-64. doi: 10.1016/j.anai.2010.04.005. |
| 19843481 | Derived | Abelson MB, Torkildsen GL, Williams JI, Gow JA, Gomes PJ, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: a phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther. 2009 Sep;31(9):1908-21. doi: 10.1016/j.clinthera.2009.09.001. |
1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
| BG002 | Bepotastine Besilate Ophthalmic Solution 1.0% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
| OG002 | Bepotastine Besilate Ophthalmic Solution 1.0% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points |
|
|
| Primary | Conjunctival Redness | Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade | Posted | Mean | Standard Deviation | Units on a scale | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Ciliary Redness | Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Episcleral Redness | Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Chemosis | Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Rhinorrhea (Runny Nose) | Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Nasal Pruritus (Itchy Nose) | Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Ear or Palate Pruritus (Itchy Ear or Palate) | Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Nasal Congestion | Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model |
|
|
|
| Secondary | Tearing | Percent of Eyes with Tearing. Scored as absent or present | Posted | Number | Percent of Eyes with Tearing Present | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Ocular Mucus Discharge | Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present | Posted | Number | Percent of Eyes with OMD Present | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Eyelid Swelling | Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| Secondary | Total Nasal Symptom | Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe | Posted | Mean | Standard Deviation | Units on a scale | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model |
|
|
|
| 0 |
| 35 |
| 4 |
| 35 |
| EG001 | Placebo | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points | 0 | 36 | 2 | 36 |
| EG002 | Bepotastine Besilate Ophthalmic Solution 1.0% | 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points | 0 | 36 | 8 | 36 |
| Eye Irritation | Eye disorders |
|
| Nasopharyngitis | Infections and infestations |
|
Agreement is between contract research organization and third parties on behalf of ISTA Pharmaceuticals, Inc.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
|
| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 minutes post CAC |
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| 15 Minutes post-dose: 20 Minute post CAC |
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| 8 Hours post-dose: 7 Minute post CAC |
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| 8 Hours post-dose: 15 Minute post CAC |
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| 8 Hours post-dose: 20 Minute post CAC |
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| 16 Hours post-dose: 7 Minute post CAC |
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| 16 Hours post-dose: 15 Minute post CAC |
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| 16 Hours post-dose: 20 Minute post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-cose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours psot-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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| 15 Minutes post-dose: 20 Minutes post CAC |
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| 8 Hours post-dose: 7 Minutes post CAC |
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| 8 Hours post-dose: 15 Minutes post CAC |
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| 8 Hours post-dose: 20 Minutes post CAC |
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| 16 Hours post-dose: 7 Minutes post CAC |
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| 16 Hours post-dose: 15 Minutes post CAC |
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| 16 Hours post-dose: 20 Minutes post CAC |
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