Leprosy, MultibacillaryPhase 2TEBULA LEPROSYNCT07918573
Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
A Phase 2 study testing Telacebec 300 mg, Telacebec 600 mg and Telacebec + Rifampicine in people with Leprosy, Multibacillary, run by Fondation Raoul Follereau at 1 site in Benin.
Trial summary
The goal of this clinical trail is to evaluate whether short-course telacebec-based regimens can induce rapid and measurable reductions in M. leprae viability, potentially establishing the foundation for future shorter, safer, and simplified therapeutic strategies for MB leprosy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leprosy, Multibacillary
- What is being tested?
- Telacebec 300 mg, Telacebec 600 mg and Telacebec + Rifampicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBenin
- Study dates
- Dec 2026to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be an individual aged 18-60 years.
- Has been diagnosed with MB leprosy with a Bacillary Index (BI) of at least 2+ on a slit skin smear (SSS).
- Have no prior leprosy treatment (WHO MDT and/or dapsone monotherapy).
- Be able to give voluntary informed consent.
- Be able to complete the full study period and follow-up (with no planned migration and an accurate, known and accessible address).
- Be able to accept hospitalisation for at least three months (site-specific requirement).
- "Body weight < 85 kg at screening." (participants with weight >= 85 kg have an increased risk of severe transaminitis under telacebec)
Who cannot join
- Unable to give voluntary informed consent.
- Is a pregnant or breastfeeding woman.
- Presenting with reinfection or relapse after WHO MDT/dapsone monotherapy, or has received anti-mycobacterial drugs in the last 30 days.
- Presenting a leprosy reaction at diagnosis.
- Being currently involved or having been involved within the last 30 days in a clinical trial.
- Has any of the following medical conditions: a baseline QTcF of >450 ms or a clinically significant ECG abnormality or significant heart disease; HIV co-infection; HBV co-infection; history of or current pancreatitis; known or suspected cirrhosis of the liver; active clinical tuberculosis; any condition which, in the opinion of the investigator, may cause harm to the patient; known alcohol or drug addiction; known uncontrolled chronic disease such as diabetes (HbA1c >10%) or renal failure (GFR <50 ml/min); anaemia requiring transfusion.
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- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to risk of dapsone-induced haemolytic anaemia (G6PD testing required at screening).
- Abnormal screening laboratory values, including: WBC <2.5 × 10⁹/L; Neutrophils <1.0 × 10⁹/L; Platelets <100 × 10⁹/L; AST or ALT >2 times the upper limit of the reference range; Albumin <30 mg/dL; Bilirubin >2 mg/dL (34 μmol/L); Calculated creatinine clearance (Cockcroft-Gault) <50 ml/min; Lipase ≥1.6 times the upper limit of the reference range.
- Other eligibility consideration - Contraception
- All women of reproductive potential must be tested for pregnancy at screening, and again before dosing at baseline (Day 0) and on Days 28, 42, 56, and 84 of the experimental treatment phase. Women with a positive pregnancy test after enrolment will have their treatment shifted to MDT if randomised to a telacebec-containing arm.
- All women of reproductive potential must use two reliable and effective methods of contraception simultaneously while taking the study medication and up to two months after the last dose of telacebec. One highly effective form of contraception must be used (hormonal, IUD, prior tubal ligation, or partner's prior vasectomy) plus one additional effective method (male latex or synthetic condom, diaphragm or cervical cap). Male participants whose female partners are of reproductive age must also use contraception for up to 90 days after the last telacebec dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roch Christian JOHNSON, Medical Doctor, Phd, HDR contact
Benin1 site
Centre de Dépistage et de Traitement de la Lèpre et de l'Ulcère de Buruli (Raoul et Madeline Follereau) de Pobè
Pobé, Pobé
Oswald ATTOLOU, Master, +229(01)94401778, oattolou@raoul-follereau.org
Esai ANAGONOU, PhD, +229(01)96826567, esaianagonou@yahoo.fr
About this study
Official title: A Multicentre, Phase 2, Open-label, Randomised, Standard of Care-controlled and Dose-ranging Clinical Trial, Evaluating Safety and Efficacy of Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
The goal of this clinical trail is to evaluate whether short-course telacebec-based regimens can induce rapid and measurable reductions in M. leprae viability, potentially establishing the foundation for future shorter, safer, and simplified therapeutic strategies for MB leprosy.
Participants will be randomised into one of the four study arms (A, B, C and D). The arm A is non interventional. For arms B, C, and D, the three-month study drug treatment will be followed by 9 months of MDT, bringing the total treatment time to 12 months. This provision of MDT ensures that the participant has received the recommended standard treatment for leprosy and is primarily for ethics considerations.
Read the detailed description
This is an open-label, randomised, controlled, multicentre phase II clinical trial conducted in Benin, Côte d'Ivoire and Ethiopia to evaluate the bactericidal efficacy of telacebec-based regimens in the treatment of multibacillary (MB) leprosy, with safety and tolerability as secondary objectives.
Participants who meet entry criteria and give consent will be randomised into four parallel groups: one control group (Group A) receiving standard WHO multidrug therapy (MDT); two investigational groups (Groups B and C) receiving telacebec monotherapy at two different dose levels; and one investigational group (Group D) receiving telacebec in combination with rifampicin. Upon completion of the assigned telacebec-based regimen, participants in Groups B, C, and D will subsequently receive standard WHO MDT.
Follow-up will be at least 12 months for all study arms; however, with the support of national programmes, patients may be followed for up to five years where possible.
Every fortnightly visit during the first three months (during which participants are taking study drugs) needs to be performed on the appointment day (±2 days). During post-IP treatment, once participants are on regular WHO MB-MDT, they are followed up on a monthly basis (-3/+2 days window). During the post-MDT period, they are followed up on a 3-monthly basis (±14 days window). The monthly dose of study medication must be taken as directly observed treatment (DOT) on the day of the visit. The Day 1 of the monthly WHO MB-MDT must also be taken as DOT.
The TEP is composed of clinicians experienced in the clinical management of leprosy, independent of the trial sites, and will provide assistance in reviewing the clinical response of participants included in the clinical trial. During the clinical follow-up, pictures of the lesions are taken systematically at every scheduled visit to document clinical evolution, identified with a code guaranteeing patient and treatment anonymity. After Day 84, pictures will be sent separately to each member of the TEP blinded to treatment allocation. The Technical Expert Panel (TEP) will give an independent assessment classifying each participant as showing clear improvement, moderate improvement, or no improvement.
At least three assessments from the TEP need to be collected for the decision. The decision will be taken by simple majority. If 4 out of 5 members provide an assessment and the decision is divided, a reserve list TEP member will be contacted.
- Conditions
- Leprosy, Multibacillary
- Being tested
- Telacebec 300 mg, Telacebec 600 mg, Telacebec + Rifampicine
- Keywords
- Tebula, Telacebec, Leprosy, Africa
- Medical subject headings
- Leprosy, Multibacillary, Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telacebec 300 mgDrug
Telacebec 300 mg once monthly × 3 months
Telacebec 600 mgDrug
Telacebec 600 mg once monthly × 3 months
Telacebec + RifampicineDrug
(Telacebec 300 mg + Rifampicine 600 mg) once monthly x 3 months
| Study group | Role | What they receive |
|---|---|---|
| (Group A) receiving standard WHO multidrug therapy (MDT) | No intervention | The World Health Organization recommends Multidrug Therapy (MDT) to cure leprosy. This standard treatment combines three medicines: (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months |
| Group B (Low dose) | Experimental | (Telacebec 100 mg x 3 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months Receives: Drug: Telacebec 300 mg |
| Group C (Hight dose) | Experimental | (Telacebec 100 mg x 6 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months Receives: Drug: Telacebec 600 mg |
| Group D (Combinaison) | Experimental | (Telacebec 100 mg x 3 + Rifampicin 300 mg x 2 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months Receives: Drug: Telacebec + Rifampicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in viable Mycobacterium leprae load in participants' skin lesions
Treatment response of leprosy infection in each participant, measured in skin biopsies taken from the same lesion at baseline and Day 84 using the Molecular Viability Assay (MVA): quantitative RT-PCR of esxA and hsp18 transcripts, standardised to 3,000 bacilli. Reported as change in log10 viability; a larger decrease indicates a greater bactericidal effect of treatment in the participant. Arms B, C and D are compared with standard WHO MB-MDT (Arm A)
Measured: Baseline (Day 0) and Day 84
Secondary outcomes (7)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Clinical and laboratory adverse events, graded for severity and assessed for relationship to study drug, in participants receiving telacebec 300 mg, telacebec 600 mg, telacebec 300 mg + rifampicin 600 mg, or WHO MB-MDT
Measured: From first dose through Day 84 (end of study drug period)
Proportion of participants with clinical improvement of leprosy skin lesions
Assessed with standardised lesion-response criteria based on clinical examination and standardised photographs, classified as clear, moderate or no improvement. Classification validated by an independent external expert panel.
Measured: Day 84 and Month 12 (end of treatment)
Incidence and severity of leprosy reactions
Number of participants with Type 1 (reversal) reactions, defined by WHO criteria, and Type 2 reactions (erythema nodosum leprosum). ENL severity scored with the ENLIST ENL Severity Scale (EESS).
Measured: Baseline through Month 24 (end of follow-up)
Change in peripheral nerve sensory function
Semmes-Weinstein monofilament thresholds at standardised sites of the hands and feet.
Measured: Baseline, Day 84, Month 12, Month 24
Change in peripheral nerve motor function
Voluntary Muscle Testing (VMT) scores.
Measured: Baseline, Day 84, Month 12, Month 24
Number of participants with new nerve function impairment
Measured: Baseline through Month 24
Change in health-related quality of life (EQ-5D)
Measured: Baseline, Day 84, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leprosy, MultibacillaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Raoul Follereau
- Sponsor type
- University, hospital or other
- Collaborators
- Instituut voor Tropische Geneeskunde, Belgium, Liverpool School of Tropical Medicine, Ministère de la Santé - Bénin, Instituto de Salud Carlos III, Kwame Nkrumah University of Science and Technology, Centre Pasteur du Cameroun, Institut National de la Santé Et de la Recherche Médicale, France, Armauer Hansen Research Institute, Ethiopia, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle, Côte d'Ivoire, Université de Sorbonne, Paris, France, Board of Governors of the Colorado State University System (CSU)
- Responsible party
- Sponsor
- Investigators
- Roch Christian JOHNSON, Medical Doctor, PhD, HDR, Principal investigator, Centre Interfacultaire de Formation et de Recherche en Environnement pour le Développement Durable (CIFRED), University of Abomey-Calavi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918573
- Sponsor's protocol ID
- TEB-LEP2025-01
- Other IDs
- 101190742
- Acronym
- TEBULA LEPROSY
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is not yet developed
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Phase 2, Open-label, Randomised, Standard of Care-controlled and Dose-ranging Clinical Trial, Evaluating Safety and Efficacy of Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
- ClinicalTrials.gov ID
- NCT07918573
- Acronym / sponsor ID
- TEBULA LEPROSY / TEB-LEP2025-01
- Conditions
- Leprosy, Multibacillary
- Keywords
- Tebula, Telacebec, Leprosy, Africa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondation Raoul FollereauUniversity, hospital or other
- Collaborators
- Instituut voor Tropische Geneeskunde, Belgium, Liverpool School of Tropical Medicine, Ministère de la Santé - Bénin, Instituto de Salud Carlos III, Kwame Nkrumah University of Science and Technology, Centre Pasteur du Cameroun, Institut National de la Santé Et de la Recherche Médicale, France, Armauer Hansen Research Institute, Ethiopia, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle, Côte d'Ivoire, Université de Sorbonne, Paris, France, Board of Governors of the Colorado State University System (CSU)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trail is to evaluate whether short-course telacebec-based regimens can induce rapid and measurable reductions in M. leprae viability, potentially establishing the foundation for future shorter, safer, and simplified therapeutic strategies for MB leprosy.
Participants will be randomised into one of the four study arms (A, B, C and D). The arm A is non interventional. For arms B, C, and D, the three-month study drug treatment will be followed by 9 months of MDT, bringing the total treatment time to 12 months. This provision of MDT ensures that the participant has received the recommended standard treatment for leprosy and is primarily for ethics considerations.
Detailed description
This is an open-label, randomised, controlled, multicentre phase II clinical trial conducted in Benin, Côte d'Ivoire and Ethiopia to evaluate the bactericidal efficacy of telacebec-based regimens in the treatment of multibacillary (MB) leprosy, with safety and tolerability as secondary objectives.
Participants who meet entry criteria and give consent will be randomised into four parallel groups: one control group (Group A) receiving standard WHO multidrug therapy (MDT); two investigational groups (Groups B and C) receiving telacebec monotherapy at two different dose levels; and one investigational group (Group D) receiving telacebec in combination with rifampicin. Upon completion of the assigned telacebec-based regimen, participants in Groups B, C, and D will subsequently receive standard WHO MDT.
Follow-up will be at least 12 months for all study arms; however, with the support of national programmes, patients may be followed for up to five years where possible.
Every fortnightly visit during the first three months (during which participants are taking study drugs) needs to be performed on the appointment day (±2 days). During post-IP treatment, once participants are on regular WHO MB-MDT, they are followed up on a monthly basis (-3/+2 days window). During the post-MDT period, they are followed up on a 3-monthly basis (±14 days window). The monthly dose of study medication must be taken as directly observed treatment (DOT) on the day of the visit. The Day 1 of the monthly WHO MB-MDT must also be taken as DOT.
The TEP is composed of clinicians experienced in the clinical management of leprosy, independent of the trial sites, and will provide assistance in reviewing the clinical response of participants included in the clinical trial. During the clinical follow-up, pictures of the lesions are taken systematically at every scheduled visit to document clinical evolution, identified with a code guaranteeing patient and treatment anonymity. After Day 84, pictures will be sent separately to each member of the TEP blinded to treatment allocation. The Technical Expert Panel (TEP) will give an independent assessment classifying each participant as showing clear improvement, moderate improvement, or no improvement.
At least three assessments from the TEP need to be collected for the decision. The decision will be taken by simple majority. If 4 out of 5 members provide an assessment and the decision is divided, a reserve list TEP member will be contacted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (Group A) receiving standard WHO multidrug therapy (MDT) | No intervention | –The World Health Organization recommends Multidrug Therapy (MDT) to cure leprosy. This standard treatment combines three medicines: (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months |
| Group B (Low dose) | Experimental | Drug: Telacebec 300 mg(Telacebec 100 mg x 3 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months |
| Group C (Hight dose) | Experimental | Drug: Telacebec 600 mg(Telacebec 100 mg x 6 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months |
| Group D (Combinaison) | Experimental | Drug: Telacebec + Rifampicine(Telacebec 100 mg x 3 + Rifampicin 300 mg x 2 once monthly x 3 months) followed by (Rifampicin 300mg x 2) + (Clofazimin 100 mg x 3) + (Dapsone 50 mg) x 12 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be an individual aged 18-60 years.
- Has been diagnosed with MB leprosy with a Bacillary Index (BI) of at least 2+ on a slit skin smear (SSS).
- Have no prior leprosy treatment (WHO MDT and/or dapsone monotherapy).
- Be able to give voluntary informed consent.
- Be able to complete the full study period and follow-up (with no planned migration and an accurate, known and accessible address).
Key exclusion criteria (11 listed)
- Unable to give voluntary informed consent.
- Is a pregnant or breastfeeding woman.
- Presenting with reinfection or relapse after WHO MDT/dapsone monotherapy, or has received anti-mycobacterial drugs in the last 30 days.
- Presenting a leprosy reaction at diagnosis.
- Being currently involved or having been involved within the last 30 days in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telacebec 300 mgTelacebec 300 mg once monthly × 3 months | Drug | Group B (Low dose) |
| Telacebec 600 mgTelacebec 600 mg once monthly × 3 months | Drug | Group C (Hight dose) |
| Telacebec + Rifampicine(Telacebec 300 mg + Rifampicine 600 mg) once monthly x 3 months | Drug | Group D (Combinaison) |
Primary outcome
Change from baseline in viable Mycobacterium leprae load in participants' skin lesions
Time frame: Baseline (Day 0) and Day 84
Treatment response of leprosy infection in each participant, measured in skin biopsies taken from the same lesion at baseline and Day 84 using the Molecular Viability Assay (MVA): quantitative RT-PCR of esxA and hsp18 transcripts, standardised to 3,000 bacilli. Reported as change in log10 viability; a larger decrease indicates a greater bactericidal effect of treatment in the participant. Arms B, C and D are compared with standard WHO MB-MDT (Arm A)
7 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: From first dose through Day 84 (end of study drug period)
Proportion of participants with clinical improvement of leprosy skin lesions
Time frame: Day 84 and Month 12 (end of treatment)
Incidence and severity of leprosy reactions
Time frame: Baseline through Month 24 (end of follow-up)
Change in peripheral nerve sensory function
Time frame: Baseline, Day 84, Month 12, Month 24
Change in peripheral nerve motor function
Time frame: Baseline, Day 84, Month 12, Month 24
Number of participants with new nerve function impairment
Time frame: Baseline through Month 24
Change in health-related quality of life (EQ-5D)
Time frame: Baseline, Day 84, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The plan is not yet developed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roch Christian JOHNSON, Medical Doctor, Phd, HDR contact
Roch Christian JOHNSON, Medical Doctor, PhD, HDR principal investigator
Centre Interfacultaire de Formation et de Recherche en Environnement pour le Développement Durable (CIFRED), University of Abomey-Calavi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telacebec 300 mg, Telacebec 600 mg and Telacebec + Rifampicine in people with Leprosy, Multibacillary, run by Fondation Raoul Follereau at 1 site in Benin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roch Christian JOHNSON, Medical Doctor, Phd, HDR (+229(01)96221132, rochchristianjohnson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in viable Mycobacterium leprae load in participants' skin lesions (time frame: Baseline (Day 0) and Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.