| Primary | Desirability of Outcome Ranking (DOOR) | DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study. | Intent to Treat (ITT) Population: All randomized subjects that were still eligible on Day 1 of the study. Analysis of DOOR will use all subjects in the ITT population. Subjects with missing values of DOOR will have their values imputed. However, summaries of observed ordinal clinical response values presented below are based on complete data without imputation. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Adequate clinical response with resolution of symptoms and no adverse events | | | Adequate clinical response with resolution of symptoms and with mild adverse events | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR). | Wilcoxon (Mann-Whitney) | The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value | <0.001 | Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates. | Pr (Higher DOOR in Short-Course) | 0.69 | | | 2-Sided | 95 | 0.63 | 0.75 | | | | |
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| Secondary | Desirability of Outcome Ranking (DOOR) | DOOR is a composite endpoint created using clinical outcomes from the first 18 days and at Outcome Assessment Visit #2 (OAV #2). It is based on adequate clinical response at OAV #2, solicited symptoms from first 18 days and number of days of antibiotics use for worsening pneumonia from the first 18 days of the study. | ITT Population: All randomized subjects that were still eligible on Day 1 of the study. Analysis of DOOR will use all subjects in the ITT population. Subjects with missing values of DOOR will have their values imputed. However, summaries of observed ordinal clinical response values presented below are based on complete data without imputation. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Resolution of Symptoms (a Component of DOOR) | This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #1. | Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Resolution of Symptoms (a Component of DOOR) | This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #2. | Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Adequate Clinical Response Rates (a Component of DOOR) | Lack of adequate clinical response at OAV #1 is defined as the presence of a medically attended visit to an Emergency Department (ED) or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 5. | Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Adequate Clinical Response Rates (a Component of DOOR) | Lack of adequate clinical response at OAV #2 is defined as the presence of a medically attended visit to an ED or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 18. | Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Reporting Solicited Symptoms | This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 5 | Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Reporting Solicited Symptoms | This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 18 | Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits | This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 5 | Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits | This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 18 | Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits | This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 5 | Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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| Secondary | Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits | This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 18 | Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2. | Posted | | Count of Participants | | Participants | | Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) | | | | ID | Title | Description |
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| OG000 | Short Course | Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. Placebo: Placebo | | OG001 | Standard Course | Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days Amoxicillin: Amoxicillin is an aminopenicillin antibiotic Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains. Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body. |
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