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Study · Randomized controlled trial · n = 42 · 1998

18 results

Comparison of LH-RH analogue 1-month depot and 3-month depot by their hormone levels and pharmacokinetic profile in patients with advanced prostate cancer.

Tunn UW, Bargelloni U, Cosciani S, Fiaccavento G, Guazzieri S, Pagano F

Urologia internationalis1 Jan 1998Cited by 37 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study18

18 results from studies that gave the peptide. 18 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In advanced prostate cancer, median leuprorelin Cmax was 20.8 ng/ml with the 3-month depot versus 10.7 ng/ml with the 1-month depot.

    In plain wordsIn advanced prostate cancer, peak leuprorelin levels were higher with the 3-month depot than the 1-month depot.

    Peptide
    Leuprolide
    Outcome
    IncreasePeak serum leuprorelin concentration
    Study

    n = 42

    Comparator
    1-month depot 3.75 mg
    Outcome group
    Pharmacokinetics · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Median peak serum concentration (Cmax) of leuprorelin
    20.8 ng/ml
    3-month depot (11.25 mg)
    Median peak serum concentration (Cmax) of leuprorelin
    10.7 ng/ml
    1-month depot (3.75 mg)

    Source sentences

    Summary
    The 3-month depot showed a higher median peak serum concentration (Cmax) of leuprorelin at 20.8 ng/ml than the 1-month depot at 10.7 ng/ml but, conversely, this did not influence the rise in serum testosterone levels.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In advanced prostate cancer, higher leuprorelin Cmax with the 3-month depot did not influence the testosterone rise compared with the 1-month depot.

    In plain wordsIn advanced prostate cancer, higher peak leuprorelin levels with the 3-month depot did not alter testosterone rises versus the 1-month depot.

    Peptide
    Leuprolide
    Outcome
    No significant changeTestosterone rise between formulations
    Study

    n = 42

    Comparator
    1-month depot
    Outcome group
    Sex hormones and fertility · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The 3-month depot showed a higher median peak serum concentration (Cmax) of leuprorelin at 20.8 ng/ml than the 1-month depot at 10.7 ng/ml but, conversely, this did not influence the rise in serum testosterone levels.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In advanced prostate cancer, remission or stabilization was comparable with monthly and three-monthly leuprorelin depots, at 86.7% and 85.2%, respectively.

    In plain wordsIn advanced prostate cancer, remission or stable disease was comparable between monthly and three-monthly leuprorelin depots.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedBest response between depot formulations
    Study

    n = 42

    Comparator
    1-month depot 3.75 mg
    Outcome group
    Tumor growth · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Best response (complete/partial remission or stabilization, EORTC criteria)
    86.7%
    1-month depot
    Best response (complete/partial remission or stabilization, EORTC criteria)
    85.2%
    3-month depot

    Source sentences

    Summary
    Based on European Organization for Research and Treatment of Cancer criteria, the best response in terms of complete/partial remissions and stabilization was comparable in the two arms at 86.7% (1-month depot) and 85.2% (3-month depot).
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  4. 04HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, both leuprorelin depot formulations produced complete pituitary down-regulation.

    In plain wordsIn advanced prostate cancer, both leuprorelin depot formulations suppressed pituitary activity.

    Peptide
    Leuprolide
    Outcome
    DecreasePituitary down-regulation
    Study

    n = 42

    Comparator
    Baseline
    Outcome group
    Sex hormones and fertility · Cancer
    Studied dose
    3.75 mg monthly or 11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    In both groups, subcutaneous injections of leuprorelin acetate injected monthly or at 3-month intervals produced a complete down-regulation of the pituitary
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  5. 05HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, both leuprorelin depots suppressed testosterone to <=50 ng/dl within the first month and maintained suppression for 9 months.

    In plain wordsIn advanced prostate cancer, both leuprorelin depots suppressed testosterone within the first month and maintained suppression for 9 months.

    Peptide
    Leuprolide
    Outcome
    DecreaseTestosterone suppression
    Study

    n = 42

    Comparator
    Baseline
    Outcome group
    Sex hormones and fertility · Cancer
    Studied dose
    3.75 mg monthly or 11.25 mg every 3 months · subcutaneous · 9 monthsAs given in this study (human).

    Measurements

    Serum testosterone castrate range
    ≤ 50 ng/dl
    both leuprorelin depots, reached within first month and maintained over 9 months

    Source sentences

    Summary
    and led to persistent suppression of testosterone and dihydrotestosterone to the castrate range (< or = 50 ng/dl for testosterone) within the first month of treatment, which thereafter could be maintained over the entire observation period of 9 months.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  6. 06HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, both leuprorelin depots suppressed dihydrotestosterone to the castrate range within the first month and maintained suppression for 9 months.

    In plain wordsIn advanced prostate cancer, both leuprorelin depots suppressed dihydrotestosterone within the first month and maintained suppression for 9 months.

    Peptide
    Leuprolide
    Outcome
    DecreaseDihydrotestosterone suppression
    Study

    n = 42

    Comparator
    Baseline
    Outcome group
    Sex hormones and fertility · Cancer
    Studied dose
    3.75 mg monthly or 11.25 mg every 3 months · subcutaneous · 9 monthsAs given in this study (human).

    Source sentences

    Summary
    and led to persistent suppression of testosterone and dihydrotestosterone to the castrate range (< or = 50 ng/dl for testosterone) within the first month of treatment, which thereafter could be maintained over the entire observation period of 9 months.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  7. 07HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, more than 80% of patients in both leuprorelin depot arms showed an objective clinical response.

    In plain wordsIn advanced prostate cancer, more than 80% in both leuprorelin depot arms showed an objective clinical response.

    Peptide
    Leuprolide
    Outcome
    Not applicableObjective clinical response
    Study

    n = 42

    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.75 mg monthly or 11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Patients with objective clinical response
    > 80%
    all patients in both arms

    Source sentences

    Summary
    A marked decrease in median prostate-specific antigen levels of 97.8% (1-month depot) and 96.6% (3-month depot) compared with baseline was observed, indicating an objective clinical response for more than 80% of all patients in both arms.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  8. 08HumanNon-randomized trialSafety outcome

    In advanced prostate cancer, the most common side effects in both leuprorelin depot groups were related to hormone deprivation.

    In plain wordsIn advanced prostate cancer, the most common side effects in both leuprorelin depot groups were related to hormone deprivation.

    Peptide
    Leuprolide
    Outcome
    Not applicableHormone-deprivation side effects
    Study

    n = 42

    Outcome group
    Adverse events · Cancer
    Studied dose
    3.75 mg monthly or 11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The most common side effects in both treatment groups were related to hormone deprivation.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  9. 09HumanNon-randomized trialPharmacokinetics

    In advanced prostate cancer, leuprorelin Cmax occurred at 3 h with the 3-month depot.

    In plain wordsIn advanced prostate cancer, leuprorelin peaked at 3 hours with the 3-month depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableTime to peak concentration, 3-month depot
    Study

    n = 27

    Outcome group
    Pharmacokinetics · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Time to Cmax of leuprorelin
    3 h
    3-month depot

    Source sentences

    Summary
    Cmax occurred at 3 h for the 3-month and at 1 h for the 1-month depot formulation.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  10. 10HumanNon-randomized trialPharmacokinetics

    In advanced prostate cancer, constant leuprorelin release began on day 7 with the 3-month depot.

    In plain wordsIn advanced prostate cancer, constant leuprorelin release began on day 7 with the 3-month depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableConstant release onset, 3-month depot
    Study

    n = 27

    Outcome group
    Pharmacokinetics · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Day constant release started
    7 day
    3-month depot, steady state

    Source sentences

    Summary
    During the steady state, constant release could be detected, starting on day 3 and day 7 for the 1-month and 3-month depot, respectively.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  11. 11HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, median PSA decreased 96.6% from baseline with the 3-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, median PSA decreased 96.6% from baseline with the 3-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    DecreasePSA reduction, 3-month depot
    Study

    n = 27

    Comparator
    Baseline
    Outcome group
    Tumor growth · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Median PSA decrease from baseline
    96.6%
    3-month depot

    Source sentences

    Summary
    A marked decrease in median prostate-specific antigen levels of 97.8% (1-month depot) and 96.6% (3-month depot) compared with baseline was observed, indicating an objective clinical response for more than 80% of all patients in both arms.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  12. 12HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, complete or partial remission or stabilization occurred in 85.2% with the 3-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, 85.2% had remission or stable disease with the 3-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableBest response, 3-month depot
    Study

    n = 27

    Outcome group
    Tumor growth · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Best response (complete/partial remission or stabilization, EORTC criteria)
    85.2%
    3-month depot

    Source sentences

    Summary
    Based on European Organization for Research and Treatment of Cancer criteria, the best response in terms of complete/partial remissions and stabilization was comparable in the two arms at 86.7% (1-month depot) and 85.2% (3-month depot).
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  13. 13HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, 3% showed disease progression with the 3-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, 3% had disease progression with the 3-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableDisease progression, 3-month depot
    Study

    n = 27

    Outcome group
    Tumor growth · Cancer
    Studied dose
    11.25 mg every 3 months · subcutaneousAs given in this study (human).

    Measurements

    Disease progression
    3%
    3-month depot group

    Source sentences

    Summary
    6.7% in the 1-month group and 3% in the 3-month depot group showed progression of the disease.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  14. 14HumanNon-randomized trialPharmacokinetics

    In advanced prostate cancer, leuprorelin Cmax occurred at 1 h with the 1-month depot.

    In plain wordsIn advanced prostate cancer, leuprorelin peaked at 1 hour with the 1-month depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableTime to peak concentration, 1-month depot
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Cancer
    Studied dose
    3.75 mg monthly · subcutaneousAs given in this study (human).

    Measurements

    Time to Cmax of leuprorelin
    1 h
    1-month depot

    Source sentences

    Summary
    Cmax occurred at 3 h for the 3-month and at 1 h for the 1-month depot formulation.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  15. 15HumanNon-randomized trialPharmacokinetics

    In advanced prostate cancer, constant leuprorelin release began on day 3 with the 1-month depot.

    In plain wordsIn advanced prostate cancer, constant leuprorelin release began on day 3 with the 1-month depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableConstant release onset, 1-month depot
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Cancer
    Studied dose
    3.75 mg monthly · subcutaneousAs given in this study (human).

    Measurements

    Day constant release started
    3 day
    1-month depot, steady state

    Source sentences

    Summary
    During the steady state, constant release could be detected, starting on day 3 and day 7 for the 1-month and 3-month depot, respectively.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  16. 16HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, median PSA decreased 97.8% from baseline with the 1-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, median PSA decreased 97.8% from baseline with the 1-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    DecreasePSA reduction, 1-month depot
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.75 mg monthly · subcutaneousAs given in this study (human).

    Measurements

    Median PSA decrease from baseline
    97.8%
    1-month depot

    Source sentences

    Summary
    A marked decrease in median prostate-specific antigen levels of 97.8% (1-month depot) and 96.6% (3-month depot) compared with baseline was observed, indicating an objective clinical response for more than 80% of all patients in both arms.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  17. 17HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, complete or partial remission or stabilization occurred in 86.7% with the 1-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, 86.7% had remission or stable disease with the 1-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableBest response, 1-month depot
    Study

    n = 15

    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.75 mg monthly · subcutaneousAs given in this study (human).

    Measurements

    Best response (complete/partial remission or stabilization, EORTC criteria)
    86.7%
    1-month depot

    Source sentences

    Summary
    Based on European Organization for Research and Treatment of Cancer criteria, the best response in terms of complete/partial remissions and stabilization was comparable in the two arms at 86.7% (1-month depot) and 85.2% (3-month depot).
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.
  18. 18HumanNon-randomized trialEfficacy outcome

    In advanced prostate cancer, 6.7% showed disease progression with the 1-month leuprorelin depot.

    In plain wordsIn advanced prostate cancer, 6.7% had disease progression with the 1-month leuprorelin depot.

    Peptide
    Leuprolide
    Outcome
    Not applicableDisease progression, 1-month depot
    Study

    n = 15

    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.75 mg monthly · subcutaneousAs given in this study (human).

    Measurements

    Disease progression
    6.7%
    1-month depot group

    Source sentences

    Summary
    6.7% in the 1-month group and 3% in the 3-month depot group showed progression of the disease.
    2 context sentences
    Summary · context
    In an open, randomized phase II pharmacokinetic study conducted in Germany and Italy, a total of 42 patients with advanced or metastatic prostate cancer (PCa) were treated for 9 months with the luteinizing hormone-releasing hormone analogue (LH-RH-a) leuprorelin acetate depot in two different formulations.
    Summary · context
    Fifteen patients received the 1-month depot and 27 patients received the newly developed 3-month depot, containing 3.75 mg and 11.25 mg, respectively.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

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