• Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)

• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

⁃ Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.