FrancophonIA/ELRC3.0 huggingface dataset:
English: Further risk minimisation measures such as additional amendments to the product information (restriction of the indication and contra-indications), communication material (dear Health Care Professional Communication) and restricted prescription were also considered during the discussions.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee arutas ka riskivähendamise lisameetmeid, nagu ravimiteabe muudatused (näidustuse piiramine ja vastunäidustused), teabematerjal (tervishoiutöötajate teatis) ja ravimi väljakirjutamise piiramine.
English: The PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee on arvamusel, et müügiloa hoidja pakutud riskivähendusmeetmed ei vähenda tõsiste kõrvaltoimete riski kliiniliselt vastuvõetavale tasemele: mis tahes lisateade neuropaatia ja kehakaalu languse riskist, mis on ravimit väljakirjutavatele arstidele juba hästi tuntud, ei aitaks ilmselt kaasa ravimi ohutumale kasutamisele.
English: 5 Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J..
Estonian: 5 Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J.. Treatment of chronic respiratory failure by Almitrine bismesylate.
English: This was supported by the fact that cases of peripheral neuropathy continued to be reported from September 2003 to November 2012 despite the implemented minimisation measures (recommendation for a sequential scheme of administration and dose adjustment initially, followed by contra-indications and warnings).
Estonian: Seda kinnitas tõsiasi, et vaatamata võetud riskivähendusmeetmetele (esialgu soovitus vaheaegadega annustamisskeemi kasutuselevõtuks ja annuse kohandamiseks, millele järgnesid vastunäidustused ja hoiatused) saadi ajavahemikus september 2003 kuni november 2012 jätkuvalt teateid perifeerse neuropaatia juhtudest.
English: • Digestive events (nausea, burning sensation and sensation of epigastric heaviness, dyspepsia),
Estonian: • seedetraktiga seotud kõrvaltoimed (iiveldus, põletus- ja raskustunne ülakõhus, düspepsia);
English: In addition, the benefit claimed by the MAH that long-term oxygen therapy can be delayed with almitrine is not substantiated by supporting data.
Estonian: Müügiloa hoidja väidet, et almitriini kasutamine võimaldab edasi lükata pikaajalise hapnikuravi vajadust, ei kinnita vastavad andmed.
English: With regards to peripheral neuropathy, a total of 2304 cases of peripheral neuropathy have been spontaneously reported in patients exposed to almitrine since the launch of the product (from 1983 to December 2012).
Estonian: Alates ravimi turuleviimisest (1983 kuni detsember 2012) on almitriini saanud patsientidel spontaanselt teatatud kokku 2304 perifeerse neuropaatia juhust.
English: Based on the above, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Estonian: Ülaltoodut arvesse võttes on ravimiohutuse riskihindamise nõuandekomitee arvamusel, et olemasolevad efektiivsusandmed, sh andmed, mis avaldati pärast esmase müügiloa andmist, näitavad heakskiidetud näidustustel suukaudse almitriini väga vähest efektiivsust, millest ei ole hingamisteede haiguste kohta omandatud teadmiste ja nende praeguste ravistrateegiate kontekstis patsientidele kasu.
English: Further to the review of the available efficacy data, including data which became available since the initial marketing authorisation, the PRAC concluded that the available data only showed very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Estonian: Olemasolevate efektiivsusandmete, sh pärast esmase müügiloa andmist avaldatud andmete alusel otsustas ravimiohutuse riskihindamise nõuandekomitee, et andmed näitavad suukaudse almitriini väga vähest efektiivsust, millest ei ole hingamisteede haiguste kohta omandatud teadmiste ja nende praeguste ravistrateegiate kontekstis patsientidele kasu.
English: The reported reactions consisted mainly of peripheral neuropathy and weight loss.
Estonian: Eelkõige on teatatud perifeersest neuropaatiast ja kehakaalu langusest.
English: The uncertainties relating to the mechanisms of action implying the vasoconstriction of pulmonary vasculature (which is inverse to the beneficial effect of LTOT on pulmonary arterial pressure) was noted by the PRAC.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee märkis samuti ebaselgust, mis on seotud almitriini toimemehhanismiga pulmonaalse vasokonstriktsiooni esilekutsumisel (mis on vastupidine pikaajalise hapnikuravi kasulikule toimele rõhu vähendamisel kopsuarterites).
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the Almitrine containing medicinal products for oral use, agrees with the recommendation therein as stated below:
Estonian: Võttes arvesse ravimiohutuse riskihindamise nõuandekomitee 16. mai 2013. aasta soovitust almitriini sisaldavate suukaudsete ravimite kohta, nõustub inimravimite komitee vastastikuse tunnustamise ja detsentraliseeritud menetluste töörühm kõnealuse soovitusega, mis on kokku võetud allpool.
English: The PRAC therefore concluded that the benefit-risk balance of almitrine containing medicinal products for oral administration is not favourable.
Estonian: Seetõttu otsustas ravimiohutuse riskihindamise nõuandekomitee, et almitriini sisaldavate suukaudsete ravimite kasulikkuse ja riski suhe on negatiivne.
English: Pneumology 1998 Mar;52(3):121-7 (PE24412) Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
Estonian: Pneumology 1998 Mar;52(3):121-7 (PE24412) 11 Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir
English: 2003 ; 70 : 275-283 (PE32001) Nowak D., Wywiol A., Magnussen H.. Almitrine in the treatment of chronic obstructive pulmonary disease with hypoxemia - a multicentre clinical study comparing two dosages.
Estonian: Nowak D., Wywiol A., Magnussen H.. Almitrine in the treatment of chronic obstructive pulmonary disease with hypoxemiaa multicentre clinical study comparing two dosages.
English: • Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
Estonian: Ka vaheaegadega raviskeemi (st kahekuuline ravi, millele järgnes ühekuuline ravikatkestus) järginud kliiniliste uuringute kirjandusandmete alusel891011 oli ravi katkestamise määr enamikus uuringutes almitriinirühmas suurem kui platseeborühmas.
English: • The PRAC took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of oral almitrine in chronic obstructive pulmonary disease (COPD).
Estonian: • ravimiohutuse riskihindamise nõuandekomitee võttis arvesse müügiloa hoidja seisukohta, et ta on esitanud kõik olemasolevad andmed ja et tal ei ole enam võimalik esitada mingeid täiendavaid andmeid suukaudse almitriini kasulikkuse tõendamiseks kroonilise obstruktiivse kopsuhaiguse ravis;
English: Overall, based on the available published data and data from spontaneous reports, the PRAC considers that almitrine use is associated with serious cases of peripheral neuropathy, some with positive rechallenge, and weight loss.
Estonian: Võttes aluseks kirjanduses avaldatud ja spontaansete teatiste andmed, on ravimiohutuse riskihindamise nõuandekomitee arvamusel, et almitriini kasutamine on seotud tõsiste perifeerse neuropaatia juhtudega, millest mõni on kordunud pärast ravi taasalustamist, ja kehakaalu langusega.
English: Concerns have also been raised with regards to the potential risks of hepatobilary disorders, skin disorders and cytopenia with the use of oral almitrine.
Estonian: Almitriini suukaudse kasutamisega seoses on probleemiks ka sellised võimalikud riskid nagu maksa ja sapiteede häired, nahakahjustused ja tsütopeenia.
English: Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
Estonian: 9 Gorecka D., Sliwinski P, Palasiewicz G, Pachocki R., Zielinski J.. Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
English: Risk minimisation measures (reduction of the dose and implementation of a sequential treatment scheme ) were implemented since the initial marketing authorisation.
Estonian: Pärast esmase müügiloa andmist võeti riskivähendusmeetmeid (annuse vähendamine ja vaheaegadega annustamisskeem).
English: Almitrine bismesylate is indicated in patients with respiratory failure with hypoxemia related to obstructive bronchitis.
Estonian: Almitriinbimesülaat on näidustatud obstruktiivsest bronhiidist tingitud hüpokseemia ja hingamispuudulikkusega patsientide raviks.
English: The PRAC considered the risk minimisations measures already implemented (reduction of the dose and implementation of a sequential treatment scheme) to mitigate the risk of neuropathies and weight loss.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee arutas neuropaatiate ja kehakaalu languse riski vähendamiseks juba võetud riskivähendusmeetmeid (annuse vähendamine ja vaheaegadega annustamiskeem kasutuselevõtmine).
English: Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
Estonian: Almitrine bismesylate: a long-term placebo- controlled double-blind study in COAD.
English: 2 Arnaud F., Bertrand A., Charpin J., Chretien J., Decroix G., Guerrin F., Kalb J.C., Lissac J., Michel F.B., Morere P.,
Estonian: Rev Mal Resp 1985; 2:S61-67 (PE10644) 2 Arnaud F., Bertrand A., Charpin J., Chretien J., Decroix G., Guerrin F., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle
English: Despite sequential doses regimen and amendments in the SmPC, the PRAC noted serious cases of neuropathy and weight loss continued to be reported, including some cases with positive rechallenge, and leading sometimes to sequelae.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee märkis, et vaatamata vaheaegadega annustamisskeemi kasutuselevõtmisele ja ravimi omaduste kokkuvõtte muudatustele teatatakse endiselt tõsistest neuropaatia ja kehakaalu languse juhtudest, mis mõnel juhul on kordunud pärast ravi taasalustamist ning mõnel juhul viinud ka püsivate jääknähtude tekkeni.
English: Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A.
Estonian: Bull Eur Physiopathol Respir 1987 ; 23(suppl 11) : 169-182 (PE10837) 8 Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F.,
English: • The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee otsustas, et suukaudse almitriini kasutamisega kaasnevad tõsised perifeerse neuropaatia ja kehakaalu languse juhud, millest mõned on seotud püsivate jääknähtudega;
English: • The PRAC considered the totality of the data available for almitrine containing products for oral administration in relation to the risk of peripheral neuropathy and weight loss.
Estonian: • ravimiohutuse riskihindamise nõuandekomitee tutvus kõigi olemasolevate andmetega perifeerse neuropaatia ja kehakaalu languse riski kohta almitriini suukaudsete ravimvormide kasutamisel.
English: Voisin C., Howard P., Ansquer J.C. Almitrine bismesylate: a long-term placebo- controlled double-blind study in COAD.
Estonian: B., Pariente R., Perrin-Fayolle M., Rochemaure J., Voisin C.. Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
English: Eur J Respir Dis 1983; 64(Suppl 126):323-330 (PE10377) 3 Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of Almitrine bismesylate in patients with chronic respiratory insufficiency.
Estonian: Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of Almitrine bismesylate in patients with chronic respiratory insufficiency.
English: The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee on arvamusel, et suukaudse almitriini kasutamisega kaasnevad tõsised perifeerse neuropaatia ja kehakaalu languse juhud, millest mõned on seotud püsivate jääknähtudega.
English: Based on the above the PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Estonian: Ülaltoodut arvesse võttes otsustas ravimiohutuse riskihindamise nõuandekomitee, et almitriini suukaudne kasutamine on seotud selliste tõsiste kõrvaltoimetega nagu perifeerne neuropaatia ja kehakaalu langus, mis mõnel juhul on püsivate jääknähtudega.
English: Overall, a significant number of cases with outcomes reported as not recovered or recovered with sequelae is not acceptable to the PRAC.
Estonian: Kokkuvõttes ei ole ravimiohutuse riskihindamise nõuandekomitee arvates vastuvõetav olukord, kus suure osa teatatud kõrvaltoime juhtude korral on tagajärjeks mitteparanemine või paranemine jääknähtudega.
English: Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J.. Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
Estonian: Eur J Clin Pharmacol 1990; 38(3) : 249-253 (PE11220) 4 Bardsley P.A., Howard P., De-Backer W., Vermeire P., Mairesse M., Ledent C., Radermecker M., Bury T., Ansquer J.. Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
English: Important weight losses and peripheral neuropathies which can potentially not recover or lead to sequelae, are still reported with almitrine despite risk minimisation measures in place for several years.
Estonian: Ehkki riskivähendusmeetmeid on võetud juba mitme aasta vältel, saadakse almitriini kasutamisel endiselt teatisi tõsisest kehakaalu langusest või perifeersest neuropaatiast, mis ei pruugi paraneda või paranevad jääknähtudega.
English: No published data focusing on the proper mechanism of almitrine in the occurrence of those adverse events was provided by the MAH.
Estonian: Müügiloa hoidja ei esitanud ka kirjandusandmeid, mis oleks nõuetekohaselt selgitanud nende kõrvalnähtude tekkemehhanismi almitriini kasutamisel.
English: The PRAC took in account the MAH's position.
Estonian: Ravimiohutuse riskihindamise nõuandekomitee võttis arvesse ka seda müügiloa hoidja seisukohta.
English: Votrient should be taken with water but without food, at least one hour before or two hours after a meal.
Estonian: Votrienti tuleb võtta veega, kuid ilma toiduta, vähemalt üks tund enne või kaks tundi pärast sööki.
English: It is available as tablets (200 mg; 400 mg).
Estonian: Seda turustatakse tablettidena (200 ja 400 mg).
English: The full EPAR for Votrient can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Votrienti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient on 14 June 2010.
Estonian: Euroopa Komisjon andis Votrienti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 14. juunil 2010.
English: The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes.
Estonian: Votrienti kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on isutus, düsgeusia (maitsehäired), kõrge vererõhk, kõhulahtisus, iiveldus, oksendamine, valu, juuste värvuse muutus, väsimus, naha hüpopigmentatsioon (naha värvuse muutus), ketendav lööve, peavalu, stomatiit (suu limaskesta põletik), kehakaalu langus ja teatavate maksaensüümide sisalduse suurenemine veres.
English: This was switched to a full marketing authorisation on 1 July 2013.
Estonian: Tingimuslik müügiluba muudeti tavaliseks müügiloaks 1. juulil 2013.
English: The safety profile of Votrient is considered acceptable and generally manageable.
Estonian: Votrienti ohutusprofiil on hästi tuntud ja üldiselt vastuvõetav.
English: The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects.
Estonian: Soovitatav annus on 800 mg üks kord ööpäevas, kuid seda võib olla vaja kõrvalnähtude korral vähendada.
English: Other information about Votrient:
Estonian: Muu teave Votrienti kohta
English: In all of the studies, the main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Estonian: Kõikides uuringutes oli efektiivsuse põhinäitaja progressioonivaba elulemus (aeg haiguse süvenemiseni).
English: It is used in patients who have been previously treated with chemotherapy (medicines to treat cancer) because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Estonian: Seda kasutatakse patsientidel, kes on saanud vähi leviku tõttu varem keemiaravi (vähiravimeid), või patsientidel, kelle vähk on progresseerunud 12 kuu jooksul pärast adjuvant- või neoadjuvantravi (pärast või enne põhiravi tehtav ravi).
English: In patients with moderate liver problems the dose should be reduced to 200 mg once a day.
Estonian: Mõõduka maksahaigusega patsientidel tuleb Votrienti annust vähendada 200 mg-ni üks kord ööpäevas.
English: This document is a summary of the European Public Assessment Report (EPAR) for Votrient.
Estonian: See on ravimi Votrient Euroopa avaliku hindamisaruande kokkuvõte.
English: Therefore, the Committee decided that Votrient's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas inimravimite komitee, et Votrienti kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: By blocking these enzymes, Votrient can reduce the growth and spread of the cancer.
Estonian: Neid ensüüme blokeerides takistab Votrient vähi kasvu ja levikut.
English: ‘Advanced' means that the cancer has started to spread;
Estonian: „Kaugelearenenud” tähendab, et vähk on levinud organismis ka mujale;
English: For more information about treatment with Votrient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Votrientiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Votrient is used to treat adults with the following types of cancer:
Estonian: Votrienti kasutatakse täiskasvanud patsientidel järgmiste vähivormide raviks:
English: Votrient is not recommended in patients with severe liver problems.
Estonian: Votrienti ei soovitata kasutada raske maksahaigusega patsientidel.
English: EPAR summary for the public pazopanib
Estonian: Kokkuvõte üldsusele pasopaniib
English: These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR', ‘PDGFR' and ‘KIT'.
Estonian: Neid ensüüme leidub vähirakkude kasvus ja levikus osalevate rakkude pinnaretseptorites, nt retseptorites VEGFR, PDGFR ja KIT.
English: What is the risk associated with Votrient?
Estonian: Mis riskid Votrientiga kaasnevad?
English: Votrient must not be used in people who are hypersensitive (allergic) to pazopanib or any of the other ingredients.
Estonian: Votrienti ei tohi kasutada patsiendid, kes on pasopaniibi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Votrient.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Votrient is a medicine that contains the active substance pazopanib.
Estonian: Votrient on ravim, mis sisaldab toimeainena pasopaniibi.
English: For the full list of all side effects reported with Votrient, see the package leaflet.
Estonian: Votrienti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
Estonian: Votrienti võtnud patsiendid elasid haiguse süvenemiseta keskmiselt 9,2 kuud ja platseebot kasutanud patsiendid 4,2 kuud.
English: Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines.
Estonian: Votrienti võrreldi platseeboga (näiv ravim) ühes põhiuuringus, milles osales 435 kaugelearenenud neerurakk-kartsinoomiga patsienti, kellest osa oli varem ravitud tsütokiinidega.
English: What is Votrient?
Estonian: Mis on Votrient?
English: Votrient has also been compared with placebo in a main study involving 369 patients with soft-tissue sarcoma whose disease had progressed during or following previous chemotherapy.
Estonian: Votrienti võrreldi platseeboga veel ühes põhiuuringus, milles osales 369 pehmekoesarkoomiga patsienti, kelle haigus oli progresseerunud varasema keemiaravi käigus või selle järel.
English: Why has Votrient been approved?
Estonian: Miks Votrient heaks kiideti?
English: On average, the patients who took Votrient lived for 20 weeks without their disease getting worse, compared with seven weeks for the patients who took placebo.
Estonian: Votrienti võtnud patsiendid elasid haiguse süvenemiseta keskmiselt 20 nädalat ja platseebot kasutanud patsiendid 7 nädalat.