1. pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). 3. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)

1. pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). 3. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)

pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)

pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)

1. pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). 3. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)

1. pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). please note participants with allergies which can be managed without treatment can be included based on the decision of the investigator (or designee). 3. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)