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Description
8.3 Females and Males of Reproductive Potential Under current FDA labeling, this subsection may include information about: Pregnancy testing Contraception Infertility This section is included when a medication may affect pregnancy status, fertility, embryo-fetal development, or reproductive decision-making
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The study used a mixed model to assess differences in average weight change over time (from baseline to the end of the study: 72 weeks for SM-1 to SM-3 and 88 weeks for SM-4)
Pharmaceutical Research (1999) 7
In the case of studies conducted on humans or human biological material, the cohorts were represented by a limited number of patients
That expectation is not unreasonable
