1. At least aged 18 years old at the time of consent (/males and females). 2. If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of child-bearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day 1, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of child-bearing potential must agree to continue to use their method of birth control for the duration of the study and 12 weeks following discharge from the study. 3. If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study and 12 weeks following discharge from the study. 4. Be in good health (ie, no acute illnesses or hospitalizations within 30 days of the study start, no planned procedures during study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant’s primary care physician), in the opinion of the Investigator, based on medical history (ie, absence of any clinically relevant abnormality) during screening. 5. Be able to understand and provide written, informed consent. 6. Must have access to a telephone, the internet, a device that reliability connects to the internet, and able to dial into Telehealth checkups and study related assessments. 7. Must be able to receive study product shipments directly to their home (ie, no Post Office Boxes), unless in a region (EU) or other location where the participant must receive the study product directly from the sites’ staff/physician.

1. At least aged 18 years old at the time of consent (/males and females). 2. If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of child-bearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day 1, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of child-bearing potential must agree to continue to use their method of birth control for the duration of the study and 12 weeks following discharge from the study. 3. If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study and 12 weeks following discharge from the study. 4. Be in good health (ie, no acute illnesses or hospitalizations within 30 days of the study start, no planned procedures during study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant’s primary care physician), in the opinion of the Investigator, based on medical history (ie, absence of any clinically relevant abnormality) during screening. 5. Be able to understand and provide written, informed consent. 6. Must have access to a telephone, the internet, a device that reliability connects to the internet, and able to dial into Telehealth checkups and study related assessments. 7. Must be able to receive study product shipments directly to their home (ie, no Post Office Boxes), unless in a region (EU) or other location where the participant must receive the study product directly from the sites’ staff/physician.