inclusion criteria: capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants).

inclusion criteria: capable of giving signed informed consent as described in appendix a which includes compliance with the requirements and restrictions listed in the icf and in this protocol. for pediatric participants: informed assent is to be provided by the participant; informed consent must be provided by the participant's legal guardian ensure that participants who are considered by the investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. participant must be an adult (≥ 18 years of age) or pediatric individual (≥ 12 to < 18 years of age weighing ≥ 40 kg) at the time of signing the icf or assent (for pediatric participants).