Materials
Two batches of each OXY injection 10IU/mL and TXA injection 100mg/mL
were used in Part 1 of the study as shown in Tables 1 and 2. These
batches were collected from sites in Kenya and Nigeria supporting the
E-MOTIVE Trial. Prior analysis of these batches of product had shown
that all batches were within their expiry date and met BP specifications
for these products in terms of assay and related substances. However,
neither the OXY nor TXA products were quality-assured, under the
definition of having been assessed and listed by WHO under the
prequalification of medicines programme or, approved by a Stringent
Regulatory Authority (SRA).