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Acknowledgments The authors thank Ryo Nakachi, Tomoko Kamisawa, Yoshinori Endo, Toru Kishitani, Tomoko Muramatsu, Yuki Matsuda, Hisayo Nishino, Aiko Ishida, Chiemi Makino, Haruna Kusaka, Emiko Kitagawa, Hisae Nakajima, Tomoko Kondo, Yoshiko Fujita, Arin Kano, Daiki Yamanaka, and the radiological technicians for their professional assistance, and Takahiro Tokunaga, Shinseikai Toyama Hospital for his helpful advices regarding statistical analysis

Specifically, the process governing approval of medicinal products in the EU generally follows similar lines as in the United States

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