https://www.sciencedirect.com/science/article/abs/pii/S0168365912000892https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_2.pdfhttps://www.pmda.go.jp/drugs/2023/P20231122002/780009000_30500AMX00282_A100_2.pdf
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