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The study has two phases: a lead-in phase in which all participants take TZP and a treatment phase in which participants, after randomization, will either continue TZP or switch to placebo

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Pyridoxine is also considered safe during lactation in normal amounts, although exceedingly high doses might transiently suppress prolactin levels and were historically used (in much larger doses than nutritional needs) to suppress lactation

The drug administration methods were intraperitoneal (i.p.) injections 60 min before incision or formalin injection