Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Age group |
14/04/2020 |
age categories added |
Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) |
Infant: 1 Month-23 Month, Infant: 0 Month-23 Month, Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
15/07/2020 |
Ethical Approval letter |
FALSE, School of Medicine Sciences, College of Health Science, Ghana, 00000, Ghana, 01 Jun 2020, , 233322063248, chrpe.knust.kath@gmail.com, |
FALSE, School of Medicine Sciences, College of Health Science, Ghana, 00000, Ghana, 01 Jun 2020, , 233322063248, chrpe.knust.kath@gmail.com, 9740_9008_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
10/08/2020 |
PDF had not yet been attached. Now, the PDF with the positive opinion of the scientific review committee is attached. |
FALSE, Scientific Review Committee, BP 242 Lambarene, Gabon, 00000, Gabon, 01 Jun 2020, , 24107989191, admin@cermel.org, |
TRUE, Scientific Review Committee, BP 242 Lambarene, Gabon, 00000, Gabon, 01 Jun 2020, 05 Dec 2019, 24107989191, admin@cermel.org, 9740_9010_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
10/08/2020 |
Date became recently available. |
FALSE, School of Medicine Sciences, College of Health Science, Ghana, 00000, Ghana, 01 Jun 2020, , 233322063248, chrpe.knust.kath@gmail.com, 9740_9008_4737.pdf |
TRUE, School of Medicine Sciences, College of Health Science, Ghana, 00000, Ghana, 01 Jun 2020, 22 Jun 2020, 233322063248, chrpe.knust.kath@gmail.com, 9740_9008_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
14/08/2020 |
A IPD sharing statement is now compulsory since 01/JAN/2020. Therefore, we added these data. |
Undecided |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
14/08/2020 |
A IPD sharing statement is now compulsory since 01/JAN/2020. Therefore, we added these data. |
|
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Individual participant data may be used for meta-analysis. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
14/08/2020 |
A IPD sharing statement is now compulsory since 01/JAN/2020. Therefore, we added these data. |
|
Beginning 9 months and ending 36 months following article publications. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
14/08/2020 |
A IPD sharing statement is now compulsory since 01/JAN/2020. Therefore, we added these data. |
|
Data might be shared with investigators whose proposed use of the data has been approved by an
independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication.
After 36 months the data will be available in our Institute's data warehouse but without investigator support other than deposited metadata. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
14/08/2020 |
A IPD sharing statement is now compulsory since 01/JAN/2020. Therefore, we added these data. |
|
Study Protocol |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
09/11/2021 |
Recruitment and follow-up are completed. |
Not yet recruiting |
Completed |