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Elizabeth Thom.

Once a hospital was approved to take part in the randomized trial, the independent data coordinating middle sent a software cards containing the encrypted randomization module to the designated community biomedical specialist to be installed on the S31 monitors at that hospital. No other personnel had access to the software or were able to adjust the monitors. A separate randomization sequence was made for every monitor. Trial Protocol Females with a singleton fetus in a lot more than 36 weeks of gestation who were attempting vaginal delivery and had cervical dilation of 2 to 7 cm were invited to participate.Safety Assessments Of the 109 individuals, 21 had grade 3 or 4 4 neutropenia during the first 6 weeks of open-label valganciclovir therapy. From week 6 through month 6, a complete of 10 of the 47 participants who received the active drug had quality 3 or 4 4 neutropenia, in comparison with 13 of 49 who received placebo . A total of 3 individuals had the drug temporarily suspended due to an absolute neutrophil count of less than 500 per cubic millimeter. All treatment interruptions occurred within the 1st 6 weeks of the analysis, and treatment was resumed after resolution of the neutropenia. The alanine aminotransferase and aspartate aminotransferase levels increased slightly at months 4 and 5 in the group of participants who received the active medication, although the differences between this group and the group that received placebo were not statistically significant or clinically significant .