- Absence of findings suggestive of active disease- For subjects with chronic diseases, maintaining stable state at least 6 months prior to screening- Willingness and ability to comply with the requirements of the study protocol- Consent to contraception

- Absence of findings suggestive of active disease- For subjects with chronic diseases, maintaining stable state at least 6 months prior to screening- Willingness and ability to comply with the requirements of the study protocol- Consent to contraception