JP7454332B2 - 酸化ストレスを低減するための方法および組成物 - Google Patents
酸化ストレスを低減するための方法および組成物 Download PDFInfo
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Description
本出願は、2016年6月15日に出願された米国仮出願番号第62/350,702号の利益を主張しており、この仮出願は、参考として本明細書中に全体が援用される。
酸化ストレスとは、細胞内に存在する活性酸素種と活性酸素種を中和する細胞の能力との不均衡を指す。活性酸素種は、細胞の核酸、タンパク質、および脂質を損傷する可能性があるスーパーオキシドラジカルによって特徴付けられる。デオキシリボース核酸(DNA)などの核酸に対する損傷は、塩基に対する損傷および二本鎖切断を含み得る。タンパク質に対する損傷は、細胞のシグナル伝達および機能に混乱を引き起こす場合がある。脂質に対する、活性酸素種が仲介する損傷は、細胞膜の乱れをもたらす可能性がある。
酸化ストレスを低減するための組成物および方法が非常に必要とされている。本開示は、この必要性に取り組み、他の関連する利点も同様に提供する。
(項目1)
対象の酸化ストレスを低減させる方法であって、カプセル化されたカンナビノイド化合物およびテルペンを含む所定量の組成物を、それを必要とする前記対象に投与するステップであって、それによって前記対象の酸化ストレスの低減をもたらすステップを含む、方法。
(項目2)
前記組成物が抗酸化剤を含む、項目1に記載の方法。
(項目3)
前記テルペンが、キラヤ(Quillaja saponaria)、またはその誘導体である、項目1に記載の方法。
(項目4)
前記対象が1つまたは複数の健康状態に悩むかまたは悩んでいると疑われる、項目1に記載の方法。
(項目5)
前記1つまたは複数の健康状態が、癌、加齢、炎症、マラリア、関節リウマチ、神経変性疾患、糖尿病、高血圧症、慢性閉塞性肺疾患、狭心症、不整脈、喘息、良性前立腺肥大症、手根管症候群、双極性障害、癌、心血管疾患、白内障、セリアック病、慢性疲労症候群、うっ血性心不全、クローン病、うつ病、皮膚炎、糖尿病、勃起不全、線維筋痛症、胃食道逆流症、緑内障、高コレステロール血症、インフルエンザ、腎臓結石、ライム病、黄斑変性症、乾癬、睡眠時無呼吸、全身性エリテマトーデス、血栓症、および耳鳴りからなる群から選択される、項目4に記載の方法。
(項目6)
前記組成物を投与するステップが前記1つまたは複数の健康状態を改善する、項目4または5に記載の方法。
(項目7)
前記対象が大気圏外を移動している、項目1に記載の方法。
(項目8)
前記対象が、太陽放射線、低波長電磁放射線、銀河宇宙線、およびそれらの組合せからなる群から選択される1つまたは複数の種類の放射線に曝露されている、項目1に記載の方法。
(項目9)
前記カンナビノイド化合物がカンナビジオール(CBD)を含む、項目1に記載の方法。
(項目10)
前記カンナビノイド化合物が0.3%未満のテトラヒドロカンナビノール(THC)を含む、項目1に記載の方法。
(項目11)
前記組成物がアルギネートをさらに含む、項目1に記載の方法。
(項目12)
前記組成物が経口投与される、項目1に記載の方法。
(項目13)
前記組成物が食品または飲料である、項目12に記載の方法。
(項目14)
前記組成物が吸入により投与される、項目1に記載の方法。
(項目15)
前記組成物が噴霧される、項目14に記載の方法。
(項目16)
前記組成物が経皮的に投与される、項目1に記載の方法。
(項目17)
前記組成物が、リナロール;B-カリオフィレン;B-ミルセン;D-リモネン;フムレン;a-ピネン;イランイラン(Cananga odorata);セイヨウノコギリソウ(Achillea millefolium);スミレ(Viola odorata);ベチバー(Vetiveria zizanoides);バニラ(Vanilla plantifolia);チューベローズ(Polianthes tuberosa);タイム(Thymus vulgaris L.);ティーツリー(Melaleuca alternifolia);タンジェリン(Citrus reticulata);クロトウヒ(Picea mariana);トウヒ(Tsuga Canadensis);カンショウコウ(Nardostachys jatamansi);スペアミント(Mentha spicata);ビャクダン(Santalum spicatum);シタン(Aniba rosaeodora);ローズマリーベルベノン(Rosmarinus officinalis);ローズマリー(Rosmarinus officinalis);バラ(Rosa damascena);テンジクアオイ(Pelargonium roseum);ラベンサラ(Ravensara aromatica);プライ(Zingiber cassumunar) マツバ(Pinus sylvestris L.) プチグレン(Citrus aurantium);ペパーミント(Mentha piperita);クロコショウ(Piper nigrum L.);パチョリ(Pogostemon cablin);パロサント(Bursera graveolens);パルマローザ(Cymbopogon martini);モクセイ(Osmanthus fragrans);オレガノ(Origanum vulgare);スイートオレンジ(Citrus sinensis);オークモス(Evernia prunastri);ナツメグ(Myristica fragrans) ニアウリ(Melaleuca viridifloria);ネロリ(別名オレンジブロッサム)(Citrus aurantium);マートル(Myrtus communis);ミルラ(Commiphora myrrha);ミモザ(Acacia decurrens);メリッサ(Melissa officinalis L.);スイートマジョラム(Origanum majorana);マヌカ(Leptospermum scoparium);レッドマンダリン(Citrus deliciosa);マンダリン(Citrus deliciosa);ホワイトロータス(Nelumbo nucifera);ピンクロータス(Nelumbo nucifera);ブルーロータス(Nelumbo nucifera);ライム(Citrus aurantifolia);ユリ(Lilum aurantum);レモングラス(Cymbopogon citratus);レモン(Citrus limonum);ラベンダー(Lavandula angustifolium);ラバンジン(Lavandula hybrida grosso);カヌカ(Kunzea ericoides);ジュニパーベリー(Juniperus cummunis);ジャスミン(Jasminum officinale);ジャスミンAbs(Jasminum sambac);ムギワラギク(Helichrysum italicum);ホワイトグレープフルーツ(Citrus x paradisi);ピンクグレープフルーツ(Citrus paradisi);ショウガ(Zingiber officinalis);ゼラニウム(Pelargonium graveolens);ブルボンゼラニウム(Pelargonium graveolens,’Herit);クチナシ(Gardenia jasminoides);ガルバナム(Ferula galbaniflua);フランキンセンス(Boswellia carterii);フランジパニ(Plumeria alba);ファーニードルホワイト(Abies alba);ファーニードルシベリア(Abies siberica);ファーニードルカナダ(Abies balsamea);スイートフェンネル(Foeniculum vulgare);Eucalyptus Smithii、Eucalyptus Radiata、Eucalyptus Globulus、Eucalyptus Citriodora、Eucalyptus Blue Mallee(Eucalyptus polybractea);エレミ(Canarium luzonicum);ディル(Anethum graveolens);ヒノキ(Cupressus sempervirens);クミン(Cuminum cyminum);コリアンダー(Coriandum sativum);ココア(Theobroma cacao);クローブ(Eugenia caryophylatta);クラリーセージ(Salvia sclarea);シスタス(別名Labdanum)(Cistus ladaniferus L.);シナモン(Cinnamomum zeylanicum);ローマンカモミール(Anthemis nobilis);ブルーカモミール(Matricaria chamomilla);セロリの種子(Apium graveolins);ベイスギ(Thuja plicata);シダーウッド、ブラッド(Juniperus virginiana);シダーウッドアトラス(Cedrus atlantica);ニンジンの種子(Daucus carota);カルダモン(Elettaria cardamomum);キャラウェイの種子(Carum carvi);カヤプト(Melaleuca cajuputi);カデ(Juniperus oxycedrus);アメリカシラカバ(Betula alba);アメリカミズメ(Betula lenta);ベルガモット(Citrus bergamia);ゲッケイジュ(Laurus nobilis);バジル(Ocimum basilicum);カミメボウキ(Ocimum sanctum);バジル(Ocimum basilicum);バルサムポプラ(Populus balsamifera);バルサムペルー(Myroxylon balsamum);アンゼリカ(Angelica archangelica L.);およびこれらの組合せからなる群から選択される1種または複数の精油をさらに含む、項目1に記載の方法。
(項目18)
前記テルペンが前記カンナビノイド化合物を用いてカプセル化されている、項目1に記載の方法。
(項目19)
医薬組成物がナノカプセルを含み、前記ナノカプセルが前記カプセル化されたカンナビノイド化合物を含む個々のナノカプセルを含む、項目1に記載の方法。
(項目20)
前記個々のナノカプセルが前記テルペンを含む、項目19に記載の方法。
(項目21)
前記ナノカプセルが吸入により前記対象に投与される、項目19に記載の方法。
(項目22)
前記ナノカプセルが気化される、項目19に記載の方法。
(項目23)
前記ナノカプセルが噴霧される、項目19に記載の方法。
(項目24)
前記ナノカプセルが経口投与される、項目19に記載の方法。
(項目25)
前記ナノカプセルが食品または飲料に組み込まれている、項目19に記載の方法。
(項目26)
前記ナノカプセルが局所投与される、項目19に記載の方法。
(項目27)
前記ナノカプセルが水溶性である、項目19に記載の方法。
(項目28)
前記対象に前記組成物を投与するステップの前に、(i)前記対象における前記酸化ストレスを検出するステップであって、任意選択で、前記対象における酸化ストレスの1つまたは複数のレベルを決定することを含む、ステップ、および(ii)(i)で検出された前記酸化ストレスに基づいて、前記組成物を前記対象に投与するステップをさらに含む、項目1に記載の方法。
(項目29)
量が、(i)で決定された前記レベルに基づいて決定される、項目28に記載の方法。
(項目30)
前記対象に前記組成物を投与するステップの後に、(i)前記対象における酸化ストレスのレベルを決定するステップ、および(ii)(i)で決定された前記レベルに基づく追加したもしくは減少させた量または投与レジメンで前記組成物を前記対象に投与するステップをさらに含む、項目1に記載の方法。
(項目31)
前記対象に前記組成物を投与するステップの後に、(i)ある期間にわたって前記対象における酸化ストレスのレベルをモニタリングするステップ、および(ii)(i)でモニタリングされた前記レベルに基づく追加されたもしくは低減した量または投与レジメンで前記組成物を前記対象に投与するステップをさらに含む、項目1に記載の方法。
(項目32)
前記酸化ストレスのレベルが、前記対象における活性酸素種または抗酸化剤(単数または複数)の測定の際に決定またはモニタリングされる、項目30または31に記載の方法。
(項目33)
(a)細胞の酸化ストレスを低減するために有効な量で存在するカプセル化されたカンナビノイド化合物、および(b)食品キャリアを含む食品組成物。
(項目34)
飲料としてパッケージ化される、項目33に記載の食品組成物。
(項目35)
固形食品としてパッケージ化される、項目33に記載の食品組成物。
(項目36)
半固形食品としてパッケージ化される、項目33に記載の食品組成物。
(項目37)
微小重力条件用にパッケージ化される、項目33に記載の食品組成物。
(項目38)
対象の細胞における酸化ストレスを低減させるために有効な量で存在するカプセル化されたカンナビノイド化合物を含む組成物;および
前記対象の前記細胞における酸化ストレスの低減をもたらすために、前記対象による食品組成物の消費のための指示書
を含むキット。
(項目39)
前記組成物が食品組成物である、項目38に記載のキット。
(項目40)
前記組成物が治療用組成物である、項目38に記載のキット。
(項目41)
前記対象が宇宙移動に従事している、項目38に記載のキット。
(項目42)
前記食品組成物が、微小重力条件下で消費するためにパッケージ化される、項目38に記載のキット。
(項目43)
前記組成物がテルペンを含む、項目38に記載のキット。
本開示のさらなる態様および利点は、本開示の例示的な実施形態だけが示され、記載されている以下の詳細な説明から当業者に容易に明らかになる。認識されるように、本開示は、他の異なる実施形態が可能であり、そのいくつかの詳細は、全て本開示から逸脱することなく、様々な明らかな点で修正が可能である。したがって、図面および説明は、本質的に例示と見なされるべきであり、限定と見なされるべきではない。
本明細書に挙げられる全ての刊行物、特許、および特許出願は、個々の刊行物、特許、または特許出願のそれぞれが、参照により組み込まれることを特にかつ個々に示されるのと同じ程度まで、参照により本明細書に組み込まれる。参照により組み込まれる刊行物および特許または特許出願が本明細書に含まれる開示と矛盾する範囲で、本明細書は、このような矛盾するいかなる資料よりも優先され、および/または上位にあることを意図している。
本発明の好ましい実施形態について、本明細書で図示し記述しているが、そのような実施形態は単なる例として提示されることが、当業者に明らかである。多数の変形、変更、および置換は、本発明から逸脱することなく、当業者に想起され得る。本明細書に記載されている本発明の実施形態に対する様々な代替形態を採用し得ることを理解するべきである。
宇宙移動用の食品組成物
有効量のカプセル化されたカンナビノイド化合物を含む食品組成物は、宇宙移動に従事する宇宙飛行士とともに運搬され得る。宇宙飛行士は、大量の放射線、例えば、太陽放射線、低波長電磁放射線、および地球または宇宙環境からの銀河宇宙線への曝露に起因して、特に大量の細胞酸化ストレスに曝される。上記の供給源からの放射線は、活性酸素種の不均衡を引き起こす可能性がある。これは脂質の過酸化を引き起こし、DNAおよびタンパク質に損傷を与える。抗酸化防御は高められてはいるが、抗酸化防御は、多くの場合、放射線曝露の増加による細胞への影響を補うには不十分である。
マイクロカプセル化された組成物の調製
キラヤ抽出物(例えば、Q Natural)、アサ油、水、および任意選択でアルギン酸ナトリウムを含む製剤を、マイクロ流体プロセッサー(例えば、Microfluidics/IDEX Corporation製のマイクロフルイダイザー)を使用して調製した。製剤は、表1に記述されるように調製した。試験1は、キラヤ抽出物(例えば、Q Natural)60g、アサ油80g、および水100gを用いて、動作圧力30,000psiで、マイクロ流体の流体プロセッサーで調製した。試験2は、キラヤ抽出物(例えば、Q Natural)10g、アサ油15g、水198g、およびアルギン酸ナトリウム2gを用いて、動作圧力30,000psiで、マイクロ流体の流体プロセッサーで調製した。
Claims (35)
- 対象の酸化ストレスを低減させることにおける使用のための組成物であって、前記組成物は、抗酸化剤と、テルペンと、カンナビノイド化合物を含む複数のマイクロカプセルとを含み、前記複数のマイクロカプセルのサイズ分布は実質的に均質であり、前記組成物は前記対象に投与され、それによって前記対象の前記酸化ストレスの低減をもたらすことを特徴とする、組成物。
- 前記組成物が酵素的抗酸化剤を含む、請求項1に記載の使用のための組成物。
- 前記テルペンが、キラヤ(Quillaja saponaria)、またはその誘導体である、請求項1に記載の使用のための組成物。
- 前記対象が1つまたは複数の健康状態に悩むかまたは悩んでいると疑われる、請求項1に記載の使用のための組成物。
- 前記1つまたは複数の健康状態が、癌、加齢、炎症、マラリア、関節リウマチ、神経変性疾患、糖尿病、高血圧症、慢性閉塞性肺疾患、狭心症、不整脈、喘息、良性前立腺肥大症、手根管症候群、双極性障害、癌、心血管疾患、白内障、セリアック病、慢性疲労症候群、うっ血性心不全、クローン病、うつ病、皮膚炎、糖尿病、勃起不全、線維筋痛症、胃食道逆流症、緑内障、高コレステロール血症、インフルエンザ、腎臓結石、ライム病、黄斑変性症、乾癬、睡眠時無呼吸、全身性エリテマトーデス、血栓症、および耳鳴りからなる群から選択される、請求項4に記載の使用のための組成物。
- 前記組成物を投与するステップが前記1つまたは複数の健康状態を改善する、請求項4または5に記載の使用のための組成物。
- 前記対象が大気圏外を移動している、請求項1に記載の使用のための組成物。
- 前記対象が、太陽放射線、低波長電磁放射線、銀河宇宙線、およびそれらの組合せからなる群から選択される1つまたは複数の種類の放射線に曝露されている、請求項1に記載
の使用のための組成物。 - 前記カンナビノイド化合物がカンナビジオール(CBD)を含む、請求項1に記載の使用のための組成物。
- 前記カンナビノイド化合物が0.3%未満のテトラヒドロカンナビノール(THC)を含む、請求項1に記載の使用のための組成物。
- 前記組成物がアルギネートをさらに含む、請求項1に記載の使用のための組成物。
- 前記組成物が経口投与される、請求項1に記載の使用のための組成物。
- 前記組成物が食品または飲料である、請求項12に記載の使用のための組成物。
- 前記組成物が吸入により投与される、請求項1に記載の使用のための組成物。
- 前記組成物が噴霧される、請求項14に記載の使用のための組成物。
- 前記組成物が経皮的に投与される、請求項1に記載の使用のための組成物。
- 前記組成物が、リナロール;B-カリオフィレン;B-ミルセン;D-リモネン;フムレン;a-ピネン;イランイラン(Cananga odorata);セイヨウノコギリソウ(Achillea millefolium);スミレ(Viola odorata);ベチバー(Vetiveria zizanoides);バニラ(Vanilla plantifolia);チューベローズ(Polianthes tuberosa);タイム(Thymus vulgaris L.);ティーツリー(Melaleuca alternifolia);タンジェリン(Citrus reticulata);クロトウヒ(Picea mariana);トウヒ(Tsuga Canadensis);カンショウコウ(Nardostachys jatamansi);スペアミント(Mentha spicata);ビャクダン(Santalum spicatum);シタン(Aniba rosaeodora);ローズマリーベルベノン(Rosmarinus officinalis);ローズマリー(Rosmarinus officinalis);バラ(Rosa damascena);テンジクアオイ(Pelargonium roseum);ラベンサラ(Ravensara aromatica);プライ(Zingiber cassumunar) マツバ(Pinus sylvestris L.) プチグレン(Citrus aurantium);ペパーミント(Mentha piperita);クロコショウ(Piper nigrum L.);パチョリ(Pogostemon cablin);パロサント(Bursera graveolens);パルマローザ(Cymbopogon martini);モクセイ(Osmanthus fragrans);オレガノ(Origanum vulgare);スイートオレンジ(Citrus sinensis);オークモス(Evernia prunastri);ナツメグ(Myristica fragrans) ニアウリ(Melaleuca viridifloria);ネロリ(別名オレンジブロッサム)(Citrus aurantium);マートル(Myrtus communis);ミルラ(Commiphora myrrha);ミモザ(Acacia decurrens);メリッサ(Melissa officinalis L.);スイートマジョラム(Origanum majorana);マヌカ(Leptospermum scoparium);レッドマンダリン(Citrus deliciosa);マンダリン(Citrus deliciosa);ホワイトロータス(Nelumbo nucifera);ピンクロータス(N
elumbo nucifera);ブルーロータス(Nelumbo nucifera);ライム(Citrus aurantifolia);ユリ(Lilum aurantum);レモングラス(Cymbopogon citratus);レモン(Citrus limonum);ラベンダー(Lavandula angustifolium);ラバンジン(Lavandula hybrida grosso);カヌカ(Kunzea ericoides);ジュニパーベリー(Juniperus cummunis);ジャスミン(Jasminum officinale);ジャスミンAbs(Jasminum sambac);ムギワラギク(Helichrysum
italicum);ホワイトグレープフルーツ(Citrus x paradisi);ピンクグレープフルーツ(Citrus paradisi);ショウガ(Zingiber officinalis);ゼラニウム(Pelargonium graveolens);ブルボンゼラニウム(Pelargonium graveolens,’Herit);クチナシ(Gardenia jasminoides);ガルバナム(Ferula galbaniflua);フランキンセンス(Boswellia carterii);フランジパニ(Plumeria alba);ファーニードルホワイト(Abies alba);ファーニードルシベリア(Abies siberica);ファーニードルカナダ(Abies balsamea);スイートフェンネル(Foeniculum vulgare);Eucalyptus Smithii、Eucalyptus Radiata、Eucalyptus Globulus、Eucalyptus Citriodora、Eucalyptus Blue Mallee(Eucalyptus polybractea);エレミ(Canarium luzonicum);ディル(Anethum graveolens);ヒノキ(Cupressus sempervirens);クミン(Cuminum cyminum);コリアンダー(Coriandum sativum);ココア(Theobroma cacao);クローブ(Eugenia caryophylatta);クラリーセージ(Salvia sclarea);シスタス(別名Labdanum)(Cistus ladaniferus L.);シナモン(Cinnamomum zeylanicum);ローマンカモミール(Anthemis nobilis);ブルーカモミール(Matricaria chamomilla);セロリの種子(Apium graveolins);ベイスギ(Thuja plicata);シダーウッド、ブラッド(Juniperus virginiana);シダーウッドアトラス(Cedrus atlantica);ニンジンの種子(Daucus carota);カルダモン(Elettaria cardamomum);キャラウェイの種子(Carum carvi);カヤプト(Melaleuca cajuputi);カデ(Juniperus oxycedrus);アメリカシラカバ(Betula
alba);アメリカミズメ(Betula lenta);ベルガモット(Citrus bergamia);ゲッケイジュ(Laurus nobilis);バジル(Ocimum basilicum);カミメボウキ(Ocimum sanctum);バジル(Ocimum basilicum);バルサムポプラ(Populus balsamifera);バルサムペルー(Myroxylon balsamum);アンゼリカ(Angelica archangelica L.);およびこれらの組合せからなる群から選択される1種または複数の精油をさらに含む、請求項1に記載の使用のための組成物。 - 前記複数のマイクロカプセルのうちの1つのマイクロカプセルが前記テルペンを含む、請求項1に記載の使用のための組成物。
- 前記組成物が吸入により前記対象に投与される、請求項1に記載の使用のための組成物。
- 前記組成物が気化または噴霧される、請求項1に記載の使用のための組成物。
- 前記組成物が経口投与される、請求項1に記載の使用のための組成物。
- 前記組成物が食品または飲料に組み込まれている、請求項1に記載の使用のための組成物。
- 前記組成物が局所投与される、請求項1に記載の使用のための組成物。
- 前記組成物が水溶性である、請求項1に記載の使用のための組成物。
- (a)抗酸化剤、(b)テルペン、(c)カンナビノイド化合物を含む複数のマイクロカプセル、および(d)食品キャリアを含む食品組成物であって、前記複数のマイクロカプセルのサイズ分布は実質的に均質であり、前記組成物中の前記カンナビノイド化合物の量が細胞の酸化ストレスを低減させるために有効な量である、組成物。
- 飲料としてパッケージ化される、請求項25に記載の食品組成物。
- 固形食品としてパッケージ化される、請求項25に記載の食品組成物。
- 半固形食品としてパッケージ化される、請求項25に記載の食品組成物。
- 微小重力条件用にパッケージ化される、請求項25に記載の食品組成物。
- 抗酸化剤と、テルペンと、カンナビノイド化合物を含む複数のマイクロカプセルとを含む組成物であって、前記複数のマイクロカプセルのサイズ分布は実質的に均質であり、前記組成物中の前記カンナビノイド化合物の量が対象の細胞における酸化ストレスを低減させるために有効な量である、組成物;および
前記対象の前記細胞における酸化ストレスの低減をもたらすための、前記対象による食品組成物の消費のための指示書
を含むキット。 - 前記組成物が食品組成物である、請求項30に記載のキット。
- 前記組成物が治療用組成物である、請求項30に記載のキット。
- 前記対象が宇宙移動に従事している、請求項30に記載のキット。
- 前記食品組成物が、微小重力条件下で消費するためにパッケージ化される、請求項30に記載のキット。
- 前記組成物がテルペンを含む、請求項30に記載のキット。
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PCT/US2017/037797 WO2017218853A1 (en) | 2016-06-15 | 2017-06-15 | Methods and compositions for reducing oxidative stress |
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Also Published As
Publication number | Publication date |
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JP2019523775A (ja) | 2019-08-29 |
MX2018015583A (es) | 2019-05-16 |
BR112018076282A2 (pt) | 2019-03-26 |
WO2017218853A1 (en) | 2017-12-21 |
WO2017218845A1 (en) | 2017-12-21 |
EA201990030A1 (ru) | 2019-06-28 |
AU2017286659A1 (en) | 2019-01-17 |
IL263676A (en) | 2019-01-31 |
AU2023278131A1 (en) | 2024-01-04 |
EP3471745A1 (en) | 2019-04-24 |
EP3471745A4 (en) | 2020-01-22 |
CN109641022A (zh) | 2019-04-16 |
US20190247325A1 (en) | 2019-08-15 |
CA3027966A1 (en) | 2017-12-21 |
US20240082174A1 (en) | 2024-03-14 |
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