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. 2017 Apr 10;11:669–681. doi: 10.2147/OPTH.S126690

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© 2017 Meier et al. This work is published and licensed by Dove Medical Press Limited

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Study design of (A) pharmacokinetic study and (B) safety study.

Notes: *PK sampling: 0 hour (pre-dose), 0.25, 0.5, 1, 2, 4, 8, and 12 hours. ^$PK sampling: 0 hour (trough–24 hours after 1st dose-trough). ^‡PK sampling: 0 hour (trough). ^ΦAll 3 subjects withdrew from the study with consent, and the withdrawal was not related to the treatment. ^#One subject was not included in the safety population because of randomization error and for not receiving the investigational product.

Abbreviations: IP, investigational product; PK, pharmacokinetics; TC, telephonic contact.