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Children were excluded from the study if they were vaccinated before six weeks of age, after one year of age, with less than three weeks elapsed between administrations of subsequent vaccine doses, with more than one vaccine brand, with unknown vaccine brand, with more than two doses of RV1, or with more than three doses of RV5.
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Administration of the first dose of study drugs was supervised by a study nurse and the administration of subsequent doses was supervised by study field workers.
The administration of subsequent platinum was significantly delayed for patients in the trabectedin/PLD combination.
The femoral vein was cannulated for administration of subsequent doses of anaesthetic (if required) and drug solutions.
The delay in the administration of subsequent platinum does not appear to have exerted an influence on OS.
Moreover, if there is clinical evidence that coagulopathy has been corrected by the first dose(s), there is no evidence to support the systematic administration of subsequent doses.
As expected, the administration of subsequent platinum to OVA-301 patients was increasingly more common as their baseline PFI was longer.
Further encouraging data in the PPS subgroup from OVA-301 showed additional benefits with the trabectedin + PLD combination upon administration of subsequent therapies.
Additionally, if any administration of subsequent doses of the series of DTP+ Hepatitis B+ Hib/OPV had occurred less than 28 days after the preceding vaccination in the series, we considered the current administration as "invalid".
Time to subsequent nonplatinum-based chemotherapy (in patients who only received this type of chemotherapy) as well as OS counted from the administration of subsequent nonplatinum-based chemotherapy were similar in each arm (HR = 0.99 and 0.98, respectively).
Median OS counted from the administration of subsequent platinum was identical at 14.9 months in each arm, and 1-year survival rates were 58% (PLD arm) and 60% (trabectedin/PLD arm).
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