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受試者退出的標(biāo)準(zhǔn)和程序

A subject’s study participation may be discontinued at any time if, in the opinion of the subject, the investigator, the IRB, or the Sponsor, it is in the best interests of the subject. Any female subjects who become pregnant during the study must immediately disclose this fact to the investigator and will be immediately discontinued from the study.

根據(jù)受試者、研究員、IRB或贊助商的意見，為了受試者的最佳利益，該受試者可隨時(shí)終止參與研究。任何女性受試者如果在研究過程中懷孕，必須立即告知研究員，屆時(shí)立即退出該研究。

Upon discontinuation from the study, subjects must return all unused study lenses to the investigator.

中止研究后，受試者必須將所有未使用的研究鏡片歸還給研究員。

1. Inadequate lens fitting – the subject is exited from the study due to an unacceptable lens fit at a visit following dispensing.

鏡片配適不合適 – 受試者由于在配鏡后的訪問中因?yàn)榕浯鞑缓线m被排除出研究。

2. Unacceptable Visual Acuity – the subject is unable to obtain or maintain acceptable visual acuity with the study lenses at a visit following dispensing.

視力不達(dá)標(biāo) – 受試者在配鏡后的訪問中配戴研究眼鏡后無法獲得或保持應(yīng)有的視力。

3. Comfort Related – the subject is exited from the study for comfort reasons at a visit following dispensing.

舒適性相關(guān)原因 – 受試者出于舒適性原因在配鏡后的訪問中退出研究。