Clinical Trial Results:
A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects.
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Summary
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EudraCT number |
2009-017282-35 |
Trial protocol |
GB NL PT |
Global end of trial date |
20 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Oct 2018
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First version publication date |
05 Oct 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
113617
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01190176 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Dec 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Sep 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Sep 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.
Note: Cervarix or Control [Al(OH)3] vaccines were administered in the HPV-015 (NCT00294047) primary study.
Subjects entered the HPV-062 study (current study) approximately one year after their HPV-015 (NCT00294047) concluding visit. Annual visits were scheduled for a maximum study duration of approximately four years in the current study.
At each visit in HPV-062 study, a gynaecological examination was performed and cervical liquid-based cytology samples were collected for cervical cytology examination and oncogenic HPV DNA testing, if the cytology reading was normal or atypical squamous cells of undetermined significance (ASC-US).
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Protection of trial subjects |
The vaccinees will be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccine.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Sep 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 11
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Country: Number of subjects enrolled |
Netherlands: 5
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Country: Number of subjects enrolled |
Portugal: 7
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Country: Number of subjects enrolled |
Russian Federation: 2
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Country: Number of subjects enrolled |
Singapore: 2
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Country: Number of subjects enrolled |
United Kingdom: 4
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Country: Number of subjects enrolled |
United States: 3
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Worldwide total number of subjects |
34
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
34
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was conducted by multiple investigators at 20 centres in Canada, Netherlands, Portugal, Russian Federation, Singapore, United Kingdom and the United States. | ||||||||||||
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Pre-assignment
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Screening details |
Although 34 subjects were enrolled in the study, 2 were excluded following eligibility criteria, leading to 32 subjects who started the study. | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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HPV-062 study subjects Group | ||||||||||||
Arm description |
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Cervarix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
HPV-015 (NCT00294047) subjects received three doses of the study vaccine administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the primary study.
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Investigational medicinal product name |
Aluminium Hydroxide [Al(OH)3]
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
HPV-015 (NCT00294047) subjects received three doses of the control vaccine administered intramuscularly, according to a 0, 1, 6 month-vaccination schedule in the primary study.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Although 34 subjects were enrolled in the study, 2 were excluded following eligibility criteria, leading to 32 subjects who started the study. |
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Baseline characteristics reporting groups
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Reporting group title |
HPV-062 study subjects Group
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Reporting group description |
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
HPV-062 study subjects Group
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Reporting group description |
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. | ||
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End point title |
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 12 [1] | ||||||||
End point description |
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥ LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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End point type |
Primary
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End point timeframe |
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 24 [2] | ||||||||
End point description |
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥ LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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End point type |
Primary
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End point timeframe |
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 36 [3] | ||||||||
End point description |
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥ LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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End point type |
Primary
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End point timeframe |
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 48 [4] | ||||||||
End point description |
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
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End point type |
Primary
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End point timeframe |
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 12 [5] | ||||||||||||
End point description |
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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End point type |
Primary
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End point timeframe |
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 24 [6] | ||||||||||||
End point description |
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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End point type |
Primary
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End point timeframe |
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 36 [7] | ||||||||||||
End point description |
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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End point type |
Primary
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End point timeframe |
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 48 [8] | ||||||||||||
End point description |
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium.
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End point type |
Primary
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End point timeframe |
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with referral to colposcopy at Month 12 [9] | ||||||||||||||||||||||
End point description |
Detection was done on all subjects irrespective of their baseline HPV DNA status.
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End point type |
Primary
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End point timeframe |
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of subjects with referral to colposcopy at Month 24 [10] | ||||||||||||||||||||||
End point description |
Detection was done on all subjects irrespective of their baseline HPV DNA status.
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End point type |
Primary
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End point timeframe |
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of subjects with referral to colposcopy at Month 36 [11] | ||||||||||||||||||||||
End point description |
Detection was done on all subjects irrespective of their baseline HPV DNA status.
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End point type |
Primary
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End point timeframe |
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of subjects with referral to colposcopy at Month 48 [12] | ||||||||||||||||||||||
End point description |
Detection was done on all subjects irrespective of their baseline HPV DNA status.
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End point type |
Primary
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End point timeframe |
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Number of subjects with referral to treatment at Month 12 [13] | ||||||||||||||
End point description |
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject’s participation in the study ended.
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End point type |
Primary
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End point timeframe |
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of subjects with referral to treatment at Month 24 [14] | ||||||||||||||
End point description |
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject’s participation in the study ended.
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End point type |
Primary
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End point timeframe |
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of subjects with referral to treatment at Month 36 [15] | ||||||||||||||||||||||||||||||||||
End point description |
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject’s participation in the study ended.
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End point type |
Primary
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End point timeframe |
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with referral to treatment at Month 48 [16] | ||||||||||||||
End point description |
If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject’s participation in the study ended.
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End point type |
Primary
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End point timeframe |
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, hence no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
AEs and SAEs: During the entire study period [from 12 months after concluding HPV-015 (NCT00294047) study visit (Visit 9/Visit 11/Last visit) up to 48 months after concluding HPV-015 (NCT00294047) study visit (Visit 9/Visit 11/Last visit)].
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Adverse event reporting additional description |
There were no adverse events (AEs) or serious adverse events (SAEs) reported during the entire study period.
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
HPV-062 study subjects Group
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Reporting group description |
HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit. | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-serious adverse events (AEs) or serious adverse events (SAEs) reported during the entire study period. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
