Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.

Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product.

Safety analysis population included all randomized participants who received any amount of study drug.

Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.

Microbiologically evaluable (ME) - TOC is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the evaluability review plan (ERP).

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.

Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.

CE-EOT population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at EOT.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.

CE-TOC population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at TOC.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.

CE-LFU population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at LFU.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.

ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.

ME-TOC population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.

Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.

ME-LFU population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.

Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10^5 CFU/mL.

Micro-ITT include all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.

Micro-ITT-all randomized participants with confirmed diagnosis of cUTI/AP and positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed=number of pathogens available for analysis at given timepoint. Participant may have had more than 1 pathogen. Multiple isolates of same species/category from same participant are counted only once towards total.

Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.

Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of pathogens available for analysis at the given timepoint.

Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.

mITT-all randomized participants with confirmed diagnosis of cUTI/AP & positive Screening urine culture defined as growth of one/two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed are number of enterobacterale pathogens. Participant may have more than 1 pathogen. Multiple isolates of same species/category from same participants are counted once towards total.

Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.

ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.

Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.

ME-TOC population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.

Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to <10^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10^5 CFU/mL.

ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP

Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.

ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint.

Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed.

ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.

Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.

ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Overall Number of Units Analyzed are the number of enterobacteral pathogens. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.

Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of participants with data available for analysis.

Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.

Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to <10^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. The point estimate and confidence interval (CI) is presented for Central and eastern Europe subgroup.

Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.

Time (days) to resolution or improvement of signs and symptoms of cUTI and AP present at baseline was defined as follows: date of the first visit at which all baseline signs/symptoms have improved by at least 1 grade with worsening of none and development of no new signs/symptoms of the index infection minus the date of randomization.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥105 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

Time to Defervescence (days) = date of first post-baseline temperature measure with maximum daily Temperature ≤38°C at the date of randomization.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall number of participants analyzed are the participants with data available for analysis.

Clinical relapse is participants who met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at the LFU Visit and the subject requires antibiotic therapy for the cUT. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

Superinfection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original Baseline pathogen[s] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the investigator as a clinical failure) during the period up to and including EOT. New infection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original baseline pathogen[s] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the Investigator as a clinical failure) in the period after EOT.

Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.

PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.

PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.

PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.

PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.

PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.