Clinical Research Directory

Inclusion Criteria: 1. ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject. 2. Subject (or caretaker) must be willing to comply with all protocol requirements. 3. Subjects must complete the SD-007 study. Exclusion Criteria: 1. Subjects who do not meet the entry criteria outlined above. 2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator) 3. Participant is one of the following: 1. Not of childbearing potential (premenarchal or male/not in possession of a uterus). 2. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control: * Abstinence from heterosexual intercourse as a lifestyle choice. * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration. * Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.