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Change in alcohol consumption and selected study-level characteristics for each primary study were extracted.
Inclusion and exclusion criteria for the primary study were previously described.
In case of doubt, the authors of the primary study were contacted.
Only women who completed the full vaccination course in the primary study were eligible for inclusion in this extended LTFU study.
As shown in Table 2, response categories 2 (i.e., intended to assess but unable) and 3 (i.e., intended to assess but not reported in primary study) were designed to identify reporting issues in primary studies and at the review-level.
Participants from the primary study were not included in the extension study if they had received a meningococcal vaccine not planned in the protocol, immunoglobulin, blood products, any investigational product, or immune-modifying drug during the study period.
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The primary study is not direct related to Pentest EC2.
The authors would like to thank the Central Health Laboratory, Sana'a, Yemen where the primary study was conducted.
The primary study is a single blind Randomised Controlled Trial.
The primary study was designed to assess the effect of sdNVP on virologic response to therapy.
The primary study was approved by the Higher Degrees Research Ethics Committee (HDREC) at Makerere University School of Public Health and the Uganda National Council for Science and Technology.
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