Trial Outcomes & Findings for 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (NCT NCT04689828)

NCT ID: NCT04689828

Last Updated: 2025-11-14

Results Overview

rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 469 participants
• Primary outcome timeframe: median FU (randomization to event or censoring) 3.65 months (range 0-12.3)
• Results posted on: 2025-11-14

Participant Flow

Informed consent was obtained from all eligible participants who were randomized via Interactive Response Technology (IRT) to one of the arms in a 1:1 ratio: 177Lu-PSMA-617 or Androgen receptor-directed therapy (ARDT).

During screening, all participants underwent imaging with the investigational product gallium (68Ga) gozetotide for the purpose of determining eligibility.

Participant milestones

Measure	177Lu-PSMA-617 (AAA617) Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Overall Study STARTED	235	234
Overall Study Participants Treated	228	232
Overall Study Full Analysis Set (FAS)	234	234
Overall Study Excluded From FAS	1	0
Overall Study Participants Not Treated	7	2
Overall Study Discontinued Study Treatment	96	223
Overall Study Safety Set	227	232
Overall Study COMPLETED	131	0
Overall Study NOT COMPLETED	104	234

Reasons for withdrawal

Measure	177Lu-PSMA-617 (AAA617) Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Overall Study Subject decision	5	5
Overall Study Adverse Event	12	12
Overall Study Physician Decision	24	32
Overall Study Progressive disease	54	173
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Treated but excluded from FAS because of protocol deviation	1	0
Overall Study Treatment ongoing at the data cut-off date of 1-Jan-2025	0	9
Overall Study Participants not treated	7	2

Baseline Characteristics

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	177Lu-PSMA-617 (AAA617) n=234 Participants Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) n=234 Participants For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.	Total n=468 Participants Total of all reporting groups
Age, Continuous	71.0 years STANDARD_DEVIATION 8.70 • n=10 Participants	71.9 years STANDARD_DEVIATION 7.65 • n=10 Participants	71.4 years STANDARD_DEVIATION 8.19 • n=20 Participants
Sex: Female, Male Female	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Male	234 Participants n=10 Participants	234 Participants n=10 Participants	468 Participants n=20 Participants
Race/Ethnicity, Customized Asian	1 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=10 Participants	5 Participants n=10 Participants	12 Participants n=20 Participants
Race/Ethnicity, Customized White	212 Participants n=10 Participants	214 Participants n=10 Participants	426 Participants n=20 Participants
Race/Ethnicity, Customized Unknown	14 Participants n=10 Participants	13 Participants n=10 Participants	27 Participants n=20 Participants

PRIMARY outcome

Timeframe: median FU (randomization to event or censoring) 3.65 months (range 0-12.3)

Population: The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.

rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.

Outcome measures

Measure	177Lu-PSMA-617 (AAA617) n=233 Participants Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) n=234 Participants For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Radiographic Progression Free Survival (rPFS)	9.30 months Interval 6.77 to NA: not able to calculate the upper bounds of the 95% Confidence Interval due to insufficient number of participants with events	5.55 months Interval 4.04 to 5.95

SECONDARY outcome

Timeframe: approx. 26.9 months from randomization to cut-off

Population: FAS comprised all participants to whom study treatment was assigned by randomization.

OS is defined as time to death for any cause.

Outcome measures

Measure	177Lu-PSMA-617 (AAA617) n=234 Participants Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) n=234 Participants For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Overall Survival (OS) (Key Secondary Endpoint)	24.48 months Interval 19.55 to 28.94	23.13 months Interval 19.61 to 25.53

SECONDARY outcome

Timeframe: From date of crossover until second radiographic progression or death, whichever comes first, assessed up to approx. 32 months

rPFS2 by BICR is defined as time from the date of crossover (ARDT to 177Lu-PSMA-617) to the date of radiographic disease progression by BICR or death from any cause for participants who crossover from ARDT arm to Lu-PSMA treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed upFrom date of randomization until date of death from any cause, assessed up to approx. 32 months

PFS is defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic, clinical, or PSA progression) or death from any cause, whichever occurs first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months

PFS2 defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first, on next-line of therapy. Next-line therapy was defined as the first new (systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EoT) reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 12, 24, 48 and anytime during randomized phase

PSA50 response was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second Prostate specific antigen (PSA) measurement ≥ 4 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization till EOT or death, whichever happens first, assessed up to approx. 32 months

Time to SSE (TTSSE) defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months

TTSTP defined as time from randomization to radiographic soft tissue progression per Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 (Soft Tissue Rules of Prostate Cancer Working Group modified Response Evaluation Criteria in Solid Tumors Version 1.1) as assessed by Blinded Independent Central Review (BICR).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until date of subsequent chemotherapy or date of death from any cause, whichever comes first, assessed up to 43 months (estimated final OS analysis)

TTCT defined as time from randomization to initiation of the first subsequent chemotherapy or death, whichever occurs first. Since participants in ARPI arm were allowed to crossover to [177Lu]Lu-PSMA-617 (AAA617) arm upon confirmation of rPD by BICR, TTCT was delayed for participants who had crossed over.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months

The FACT-P total score determines the level of prostate cancer specific health related quality of life (HRQoL). The higher the FACT-P score, the better the QoL. FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From screening up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months (estimated final OS analysis)

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization till 30 day safety follow-up, assessed up to 43 months (estimated final OS analysis).

The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Treatment emergent adverse events falling into the category of myelosuppression, renal toxicity or second malignancy will be recorded beyond 30 day safety observation period.

Outcome measures

Outcome data not reported

Adverse Events

177Lu-PSMA-617

Serious events: 46 serious events

Other events: 217 other events

Deaths: 142 deaths

Androgen Receptor-directed Therapy (ARDT)

Serious events: 76 serious events

Other events: 208 other events

Deaths: 157 deaths

Serious adverse events

Measure	177Lu-PSMA-617 n=227 participants at risk Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) n=232 participants at risk For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Blood and lymphatic system disorders Anaemia	1.8% 4/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Blood loss anaemia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Febrile neutropenia	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Neutropenia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Thrombocytopenia	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Angina pectoris	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Aortic valve disease mixed	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Atrial fibrillation	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Bradycardia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Cardiac arrest	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Cardiac failure	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Cardiac failure acute	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Cardiac disorders Myocardial infarction	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Endocrine disorders Hyperthyroidism	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Eye disorders Visual impairment	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Abdominal distension	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Abdominal pain	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Constipation	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Dysphagia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Intestinal ischaemia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Nausea	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Oral pain	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Rectal haemorrhage	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Stomatitis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Vomiting	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Asthenia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Chest pain	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Fatigue	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders General physical health deterioration	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Malaise	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Multiple organ dysfunction syndrome	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Pain	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.7% 4/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Polyp	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Pyrexia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Hepatobiliary disorders Cholecystitis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Immune system disorders Anaphylactic reaction	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Bronchitis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations COVID-19	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations COVID-19 pneumonia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Cellulitis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Gastroenteritis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Infection	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Influenza	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Pneumonia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Pyelonephritis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Respiratory tract infection	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Sepsis	1.3% 3/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Sinusitis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Skin infection	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Staphylococcal infection	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Urinary tract infection	1.8% 4/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.7% 4/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations Urosepsis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Craniocerebral injury	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Femur fracture	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Joint injury	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Ligament sprain	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Investigations Alanine aminotransferase increased	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Investigations Aspartate aminotransferase increased	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Dehydration	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Hypokalaemia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Back pain	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.7% 4/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Fistula	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Osteitis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Pathological fracture	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Cerebrovascular accident	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Coma	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Haemorrhage intracranial	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Hyperaesthesia	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Ischaemic stroke	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Meningism	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Neurotoxicity	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Sciatica	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Spinal cord compression	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	2.2% 5/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Syncope	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Transient ischaemic attack	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Psychiatric disorders Confusional state	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Acute kidney injury	0.88% 2/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	2.2% 5/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Haematuria	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Hydronephrosis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Renal colic	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Renal failure	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Renal haemorrhage	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Ureteric obstruction	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Urinary incontinence	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Urinary retention	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Urine abnormality	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Deep vein thrombosis	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.00% 0/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Embolism	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Hypertension	0.44% 1/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Hypovolaemic shock	0.00% 0/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.43% 1/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.

Other adverse events

Measure	177Lu-PSMA-617 n=227 participants at risk Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.	Androgen Receptor-directed Therapy (ARDT) n=232 participants at risk For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
Blood and lymphatic system disorders Anaemia	26.0% 59/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	19.0% 44/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Neutropenia	5.3% 12/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Blood and lymphatic system disorders Thrombocytopenia	7.5% 17/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	3.0% 7/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Eye disorders Dry eye	6.2% 14/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	0.86% 2/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Constipation	21.6% 49/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	13.8% 32/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Diarrhoea	16.7% 38/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	9.9% 23/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Dry mouth	59.5% 135/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	2.6% 6/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Nausea	32.2% 73/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	12.5% 29/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Gastrointestinal disorders Vomiting	11.5% 26/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.2% 12/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Asthenia	31.7% 72/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	28.4% 66/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Fatigue	23.8% 54/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	25.4% 59/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Oedema peripheral	8.4% 19/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	12.5% 29/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
General disorders Pain	2.6% 6/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.2% 12/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Infections and infestations COVID-19	15.9% 36/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	11.2% 26/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Injury, poisoning and procedural complications Fall	2.6% 6/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	6.0% 14/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Investigations Blood alkaline phosphatase increased	6.2% 14/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	7.8% 18/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Investigations Lymphocyte count decreased	5.3% 12/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	1.3% 3/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Investigations Weight decreased	6.6% 15/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	13.8% 32/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Decreased appetite	21.6% 49/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	19.0% 44/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Metabolism and nutrition disorders Hypokalaemia	2.2% 5/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	8.2% 19/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Arthralgia	20.3% 46/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	23.3% 54/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Back pain	13.7% 31/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	19.4% 45/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Bone pain	8.8% 20/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	7.3% 17/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.4% 10/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	6.9% 16/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 13/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.6% 13/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 17/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	11.6% 27/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Dizziness	4.8% 11/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.6% 13/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Dysgeusia	8.4% 19/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	2.6% 6/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Nervous system disorders Headache	8.4% 19/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	4.7% 11/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Psychiatric disorders Insomnia	3.5% 8/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.6% 13/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Renal and urinary disorders Haematuria	1.8% 4/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	7.3% 17/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Cough	6.6% 15/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.2% 12/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.4% 10/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	5.2% 12/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Hot flush	6.6% 15/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	9.5% 22/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
Vascular disorders Hypertension	2.6% 6/227 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.	9.5% 22/232 • From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER