inclusion criteria each participant must meet the following criteria to be enrolled in this study. 1. at least aged 18 years old at the time of consent. 2. if female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing 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 iud, intrauterine system (ius), transdermal hormonal implant, vaginal hormonal ring, or 2 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 childbearing 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. 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. if access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits. 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.

inclusion criteria each participant must meet the following criteria to be enrolled in this study. 1. at least aged 18 years old at the time of consent. 2. if female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing 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 iud, intrauterine system (ius), transdermal hormonal implant, vaginal hormonal ring, or 2 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 childbearing 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. 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. if access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits. 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.

inclusion criteria each participant must meet the following criteria to be enrolled in this study. at least aged 18 years old at the time of consent. if female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing 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 iud, intrauterine system (ius), transdermal hormonal implant, vaginal hormonal ring, or 2 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 childbearing 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. 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. 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. be able to understand and provide written, informed consent. 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. if access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits. 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.

inclusion criteria each participant must meet the following criteria to be enrolled in this study. at least aged 18 years old at the time of consent. if female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing 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 iud, intrauterine system (ius), transdermal hormonal implant, vaginal hormonal ring, or 2 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 childbearing 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. 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. 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. be able to understand and provide written, informed consent. 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. if access to the internet precludes involvement, then paper diaries may be completed and promptly entered into the data capture system at the study centers as part of the regular follow-up visits. 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.

inclusion criteria: each participant must meet the following criteria to be enrolled in this study. at least aged 18 years old at the time of consent. 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 (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to day 1, such as an intrauterine device (iud), implant, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. 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. 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. 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. be able to understand and provide written, informed consent. must have access to the internet and a device that reliability connects to the internet and is able to dial into telehealth checkups and study related assessments. must be able to receive study product shipments directly to their home (ie, no post office boxes).

inclusion criteria: each participant must meet the following criteria to be enrolled in this study. at least aged 18 years old at the time of consent. 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 (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to day 1, such as an intrauterine device (iud), implant, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. 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. 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. 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. be able to understand and provide written, informed consent. must have access to the internet and a device that reliability connects to the internet and is able to dial into telehealth checkups and study related assessments. must be able to receive study product shipments directly to their home (ie, no post office boxes).

inclusion criteria: each participant must meet the following criteria to be enrolled in this study. 1. at least aged 18 years old at the time of consent. 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 (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to day 1, such as an intrauterine device (iud), implant, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. 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 the internet and a device that reliability connects to the internet and is 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).

inclusion criteria: each participant must meet the following criteria to be enrolled in this study. 1. at least aged 18 years old at the time of consent. 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 (other than a combination estrogen/progestin hormonal contraceptive) for at least 1 month prior to day 1, such as an intrauterine device (iud), implant, or two forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. 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 the internet and a device that reliability connects to the internet and is 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).