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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1225-1085 | Other Identifier | UTN | |
| QHD00010 | Other Identifier | Sanofi Pasteur |
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Primary Objective:
To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants.
Secondary Objective:
Study duration per participant was approximately 28 days including: 1 day of screening and vaccination, a safety follow-up telephone call and an end of study visit approximately at Day 8 and 28 after vaccination, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: QIV-HD | Experimental | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
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| Group 2: QIV-SD | Active Comparator | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. | Day 28 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. | Day 28 (post-vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. | Day 0 (pre-vaccination) and Day 28 (post-vaccination) |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 3920005 | Fukuoka | Japan | ||||
| Investigational Site Number 3920004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36906404 | Background | Sanchez L, Nakama T, Nagai H, Matsuoka O, Inoue S, Inoue T, Shrestha A, Pandey A, Chang LJ, De Bruijn I; QHD00010 Study Group. Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults >/= 60 years of age: Results from a phase III, randomized clinical trial. Vaccine. 2023 Apr 6;41(15):2553-2561. doi: 10.1016/j.vaccine.2023.02.071. Epub 2023 Mar 10. |
| Label | URL |
|---|---|
| EFC15150 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 2100 participants were enrolled and randomized between 21 October 2020 to 14 January 2021.
The study was conducted at 10 active centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | QIV-HD | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| FG001 | QIV-SD | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2020 | Dec 24, 2021 |
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Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).
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Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
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| Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC |
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| Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies |
GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer <10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. | Day 28 (post-vaccination) |
| Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) is reported in the outcome measure. | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Within 30 minutes post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Within 7 days post-vaccination |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. | Within 28 days post-vaccination |
| Number of Participants Reporting Serious Adverse Events (SAEs) | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | From Day 0 up to Day 28 post-vaccination |
| Koganeishi |
| Japan |
| Investigational Site Number 3920006 | Kumamoto | Japan |
| Investigational Site Number 3920001 | Osaka | Japan |
| Investigational Site Number 3920003 | Shinjuku-Ku | Japan |
| Investigational Site Number 3920008 | Shinjuku-Ku | Japan |
| Investigational Site Number 3920009 | Shinjuku-Ku | Japan |
| Investigational Site Number 3920002 | Suita-Shi | Japan |
| Investigational Site Number 3920007 | Toshima-Ku | Japan |
| Investigational Site Number 3920010 | Yokohama | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | QIV-HD | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| BG001 | QIV-SD | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. | Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. | Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 (post-vaccination) |
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| Secondary | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination) and Day 28 (post-vaccination) |
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| Secondary | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer <10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 (post-vaccination) |
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| Secondary | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) is reported in the outcome measure. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Analysis was performed on safety analysis set (SafAS) population which included participants who had received the study vaccine and had any safety data available. | Posted | Count of Participants | Participants | Within 30 minutes post-vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Analysis was performed on the SafAS population. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. | Analysis was performed on SafAS population. | Posted | Count of Participants | Participants | Within 28 days post-vaccination |
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| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | Analysis was performed on the SafAS population. | Posted | Count of Participants | Participants | From Day 0 up to Day 28 post-vaccination |
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Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination.
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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 | QIV-HD | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. | 0 | 1,049 | 2 | 1,049 | 614 | 1,049 |
| EG001 | QIV-SD | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. | 0 | 1,051 | 5 | 1,051 | 569 | 1,051 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA23.1 | Systematic Assessment |
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| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
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| Patella Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA23.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
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| Still's Disease | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDRA23.1 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA23.1 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA23.1 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA23.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA23.1 | Systematic Assessment | Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2021 | Dec 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| A/H3N2-like |
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| B/Victoria-like |
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| B/Yamagata |
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| A/H3N2-like | GMT ratio | 2.25 | 2-Sided | 95 | 2.03 | 2.50 | The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was >1 between groups for each of the comparisons. |
| B/Victoria-like | GMT ratio | 2.55 | 2-Sided | 95 | 2.31 | 2.81 | The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was >1 between groups for each of the comparisons. |
| B/Yamagata | GMT ratio | 3.12 | 2-Sided | 95 | 2.85 | 3.42 | The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was >1 between groups for each of the comparisons. |
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