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Key inclusion criteria common to the four registries were: all adult patients with a diagnosis of NV-AMD willing and able to provide informed consent personally or by legal proxy; treatment with ranibizumab according to local practices and protocols, and within the local licensed indication of ranibizumab.
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Written informed consent, signed and personally dated, is obtained from each patient before inclusion in the trial.
All participants provided written, informed consent prior to any data collection, either personally, or via their appointed legal guardian.
According to the ICH E6 Guideline for Good Clinical Practice, subjects who will be enrolled in the trial with the consent of the subjects' legally acceptable representative will be informed about the trial to the extent compatible with the subjects' understanding and, if capable, the subject will be asked to sign and personally date the written informed consent.
This is not informed consent but ill-informed consent, with a side of coercion.
The elements of informed consent are threshold, information, and consent.
The critical issue is informed consent.
It's a battle over choice and informed consent.
It was sometimes used in patients without their consent, or at least without informed consent.
Participants signed informed consent.
Written informed consent.
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