JP2012521224A - 危険有害性薬剤の注入システム - Google Patents
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Abstract
【選択図】図2
Description
[0036]「アシル」はラジカル‐C(O)Rを指し、ここにRは、本明細書に定義されている、水素、アルキル、シクロアルキル、シクロヘテロアルキル、アリール、アリールアルキル、ヘテロアルキル、ヘテロアリール、ヘテロアリールアルキルである。代表的な例には、限定するわけではないが、ホルミル、アセチル、シクロヘキシルカルボニル、シクロヘキシルメチルカルボニル、ベンゾイル、ベンジルカルボニルなどが含まれる。
定義されているアルキル基又はシクロアルキル基を表す。代表的な例には、限定するわけではないが、メチルアミノ、エチルアミノ、1‐メチルエチルアミノ、シクロヘキシルアミノなどが含まれる。
[0062]又はその薬学的に許容され得る塩、溶媒和物、水和物、酸化物、又はN‐オキシドである。幾つかの実施形態では、当該医薬は、メトトレキサートである。
[0082]様々な態様では、本開示は、危険有害性薬剤の注入に関する。幾つかの実施形態では、危険有害性薬剤は、細胞毒性薬剤である。本開示に従って使用してもよいとされる細胞毒性薬剤の例には、限定するわけではないが、6‐メルカプトプリン、6‐チオイノシン酸、アザチオプリン、クロラムブシル、シクロホスファミド、サイトホスファン、シタラビン、メルファラン、メトトレキサート、ウラムスチン、抗組織壊死因子生物製剤、抗サイトカイン生物製剤、細胞受容体拮抗剤、細胞受容体類縁体、及び上記のそれぞれの誘導体が含まれる。これらの薬剤の幾つかは、直接的に細胞を殺すか又は細胞の代謝を妨げることによって作用するので、「細胞毒性」という呼ばれ方をしている。このように作用する細胞毒性薬剤は、その最大効果を急速に分裂してゆく細胞に対して発現させる。急速に分裂している腫瘍細胞の場合、細胞毒性薬剤は、これらの細胞を殺すよう作用するので、特に有効である。この活動は過活動免疫応答に関与する細胞を抑制することもでき、その結果、疾患活動が低下することで、細胞毒性薬剤は、関節リウマチ(及び他の自己免疫疾患)、狼瘡、脈管炎、及び関係する病態の様な疾患を治療することができる。基本的な作用機序は、過活動免疫応答の抑制であり、それにより抗炎症効果がもたらされる。例えば、その様な疾患を治療するのに低用量で使用される場合、細胞毒性メトトレキサートの作用方式は、抗炎症であり、細胞毒性ではない。
[0084]幾つかの実施形態では、注入される危険有害性薬剤は、メトトレキサート及び/又は以下に更に説明されている構造式(I)によって与えられるメトトレキサートの1つ又はそれ以上の誘導体である。1つの態様では、本開示は、メトトレキサート及び/又はメトトレキサートの誘導体を動力駆動式注入器により約5秒未満で注入することに関する。幾つかの実施形態では、メトトレキサート及び/又はメトトレキサートの誘導体及び/又はその薬学的に許容され得る塩、溶媒和物、水和物、酸化物、及びN‐オキシドが注入される。幾つかの実施形態では、本開示は、メトトレキサート及び/又はメトトレキサートの誘導体と1つ又はそれ以上の薬学的に許容され得る賦形剤の注入に関する。幾つかの実施形態では、本開示は、メトトレキサート及び/又はメトトレキサートの誘導体の薬学的に許容され得る塩の注入に関する。幾つかの実施形態では、本開示は、メトトレキサートと薬学的に許容され得る賦形剤を備える薬学的組成物の注入に関する。
[0085]幾つかの実施形態では、本開示は、ジェット注入器による危険有害性薬剤の注入に関する。幾つかの実施形態では、ジェット注入器は、針支援式ジェット注入器である。幾つかの実施形態では、ジェット注入器は、針なしジェット注入器である。幾つかの実施形態では、危険有害性薬剤、及び/又はその薬学的に許容され得る塩、溶媒和物、水和物、酸化物、及びN‐オキシドが注入される。幾つかの実施形態では、1つ又はそれ以上の危険有害性薬剤と1つ又はそれ以上の薬学的に許容され得る賦形剤を備える薬学的組成物が注入される。幾つかの実施形態では、危険有害性薬剤の薬学的に許容され得る塩が注入される。幾つかの実施形態では、本開示は、メトトレキサートと薬学的に許容され得る賦形剤を備える薬学的組成物の注入に関する。
[0086]様々な態様では、本開示は、危険有害性薬剤に関する。様々な実施形態では、本開示は、構造式(I):
[0094]典型的に、危険有害性薬剤の生物学的利用能は、危険有害性薬剤が経静脈的に注入又は投与された場合には消化管の中で崩壊して被投与者の身体から消えてしまうことがないため、或いは危険有害性薬剤が組織内へ注入されたなら全身に回る前に横切らなくてはならない組織構造又は構成要素がないので、100%に近くなる。危険有害性薬剤の薬物動態及び/又は生物学的利用能を患者、用量、又は他の危険有害性薬剤特性に適した特定の様式で維持するためには、危険有害性薬剤を投与するやり方を変えれば、当該危険有害性薬剤の薬物動態もまた改変され得る。
[0102]幾つかの先行研究により示されている様に、メトトレキサートの正規用量を増やせば化合物の有効性の増加をもたらすかどうかは今のところ不明である。しかし、明らかなことは、メトトレキサートの用量が増加するにつれ、細胞毒性と関連する副作用も増加することである。例えば、Furstらは、46人の患者でメトトレキサートの経口投与量を週当たり5mg/m2(7.5mgから10mg)から週当たり10mg/m2(15mgから22mg)に増やした場合の効果を評価した(Furst, D.E., et al., J. Rheumatol, 1989; 16: 313-320参照)。この研究で、著者らは、メトトレキサートの用量を高くすると、細胞毒性増加へ向かう傾向を伴って用量比例有効性応答が得られることを述べている。しかしながら、Lambertらにより行われた別の研究は、メトトレキサートの用量増加による有効性の改善を見い出さなかった(Lambert, C. M., et al.. Arthritis and Rheumatism, 2004; 50: 364-371参照)。この研究では、64人の患者で筋肉内メトトレキサート投薬量を週当たり15mgから週当たり45mgに引き上げた場合の効果が評価された。著者らは、週当たり15mgの経口投与から筋肉内投与への切り替え後、数人の患者で、疾患活動性スコア(DAS)の改善を観測した(平均DAS28は5.6から5.2へ減少)。好ましいDAS28スコア(DAS28<3.2)を実現できていない54人の患者は、偽薬を与えられた患者と比べても疾患の改善に何ら差異を示さなかった。
[0105]幾つかの研究は、メトトレキサートを経口投与した場合にはメトトレキサートの生物学的利用能の変動性が大きいことを明らかにしている。メトトレキサートの経口による生物学的利用能は、用量が増加するにつれて下降することを示唆する証拠がある。例えば、Hermanらは、関節リウマチの患者41人で週当たり10mg/m2の用量で静脈内投与及び経口投与されたメトトレキサートの生物学的利用能を特徴付けた(Herman, R.A., et al, J. Pharm. Sci., 1989; 78: 165-171参照)。著者らは、経口投与されたメトトレキサートの吸収量は、同量の静脈内投与後に観測された全吸収量の約70%±27%に過ぎないことを見い出した。更に、Hamiltonらは、関節リウマチの患者21人で、開始投薬量を週当たり7.5mg、平均維持用量を週当たり17mgとして、筋肉内投与対経口投与によるメトトレキサートの生物学的利用能を比較した(Hamilton, R. A., and Kremer, J. M., Br. J. Rheum., 1997; 36: 86-90参照)。著者らは、経口投与後のメトトキシレートの全吸収量は、維持投薬量の間に、開始投薬量で見られた全吸収量に対し約13.5%下がることを見い出した。
[0112]近年、Braunらは、活動性関節リウマチの患者375人で、週当たり15mgの開始用量での経口投与対皮下投与によるメトトレキサートの臨床的有効性及び安全性を比較した、6ヶ月間の二重盲検法による対照臨床試験の結果を報告した(Braun, J. et al., Arthritis and Rheumatism, 2008; 58: 73-81参照)。16週後、皮下メトトレキサートを開始した患者では、経口メトトレキサートを開始した患者に比べ有意に多くの患者が、米国リウマチ学会の20%改善判定基準(ACR20)の実現に成功した。具体的には、皮下メトトレキサートを開始した患者の85%がACR20成果を実現したのに対し、経口メトトレキサートを開始した患者では77%であった。
[0119]Wegrzynらは、関節リウマチの患者143人の調査で、経口投与対筋肉内投与によるメトトレキサートの有効性及び認容性を比較した(Wegrzyn, J. et at., Annul Rheum. Diseas., 2004; 63: 1232-1234参照)。この研究の患者は、当初メトトレキサートを筋肉内的に与えられたが、その後、研究に入るまでの大凡3ヶ月間供給を欠いた後に経口投与に切り替えられた。その後、47人の患者をメトトレキサートの筋肉内投与に戻し3ヶ月間観測した。
[0127]本開示の危険有害性薬剤は、限定するわけではないが、癌、関節リウマチ、若年性関節リウマチ、乾癬性関節炎、全身性紅斑性狼瘡、ステロイド耐性多発性筋炎又は皮膚筋炎、ヴェゲナー肉芽腫症、結節性多発性動脈炎、及び脈管炎を含め、開示されている危険有害性薬剤が治療上有効であることが知られているか、有効であると考えられているか、又は今後有効であると判定されるような疾患又は障害に苦しむ患者であって、幾つかの実施形態ではヒトである患者、に投与することができる。一部の特定の実施形態では、本開示の危険有害性薬剤は、関節リウマチを治療するのに使用されてもよい。
[0129]本明細書に開示されている特定の疾患の治療に有効となる危険有害性薬剤の量は、少なくとも一部は、疾患の性質に依存し、当技術で既知の標準的な技法によって求めることができる。加えて、最適投薬範囲を特定する上で助けとなるように、生体外又は生体内評定が採用されてもよい。投薬計画及び投薬間隔も、当業者に知られている方法によって求めることができる。投与される危険有害性薬剤の量は、数ある因子の中でも特に、治療される被投与者、被投与者の体重、疾患の重篤度、投与経路、及び処方する医師の判断に依存する。
[00140]典型的な皮下シリンジは、注入を送達するのに使用者の指の1本又はそれ以上の押し出す力を利用している。幾つかの実施形態では、本開示の動力駆動式注入器は、被投与者が、その様な押し出し力を用いる必要なしに、1つ又はそれ以上の危険有害性薬剤を事前に設定された深さに1回の注入につき約5秒未満で繰り返し正確に投与するのを支援するように構成されている。
自動注入器及び針支援式ジェット注入器の両方の実施形態の幾つかで使用されている針は、26ゲージから28ゲージの間であり、幾つかの実施形態は約27ゲージである。所望の注入を生み出すべく、例えばミニ針を含めた他の構成要素が協働的に構成されている場合、他の針ゲージを使用することもできる。幾つかの実施形態では、注入器12の構成要素は、1つ又はそれ以上の医薬を経皮注入部位にジェット注入するように構成することができる。
X:サンプルを採取。
n/a:該当せず。
n/a:該当せず。
b:AUC(0−inf)の外挿が20%より多いか又はRsqが<0.800であったため、値を報告せず。
-:計算せず。
14 外ハウジング部材
14a、14b 嵌め合い部分
15 スロット
16 スリーブ
18 シリンジ
20 容器部分
22 流体室
24 針
26 針先端
28 プランジャ
32 針ハブ
33 衝撃吸収装置
35 シリンジフランジ
36 シリンジ本体
51 狭口径部分
52 圧縮ばね
54 内ハウジング
56 トリガ突起
58 ラムの陥凹
60 ラム
64 ラッチハウジング、ラッチ
65 リッジ
66 針ガード
67 フランジ
68 ラッチ掛け部分
69 タブ
70 ロックリング
71 上腕部
72 圧縮コイルばね
73 下腕部
74 開口部、タブ
77 フランジ
80 安全部材
82 脚部
84 安全部材本体
86 タブ
92 近位切欠
93 遠位切欠
94 遠位切欠の上面
95 スロット
96 孔
110 キャップ
112 突起
114 遠位リッジ
116 上稜線
118、120 縁
130 注入中の最終圧力
132 注入器の射出時点
134 注入の完了時点
136 注入中の初期圧力とピーク圧力
200 医薬
202 ジェットノズル
204 ジェット出口
Claims (21)
- 注入システムにおいて、
動力駆動式注入器であって、
危険有害性薬剤を収容するように構成されている容器と、
前記危険有害性薬剤を注入するための、前記容器と関係付けられている注入出口部材と、
前記危険有害性薬剤を注入するため、当該危険有害性薬剤を前記流体室から前記出口部材を通して押し出すように構成されている射出機構と、
注入を生じさせるため前記射出機構に動力供給するように当該射出機構と関係付けられているエネルギー源と、
前記射出機構を作動させるように当該射出機構と関係付けられているトリガ機構と、を備える動力駆動式注入器と、
前記容器に収容されている危険有害性薬剤の治療有効量と、を備えており、
前記動力駆動式注入器は、前記危険有害性薬剤の治療有効量を約5秒未満で注入するように構成されている、注入システム。 - 前記危険有害性薬剤は、ボツリヌス毒素、注入できる金、6‐メルカプトプリン、6‐チオイノシン酸、アザチオプリン、クロラムブシル、シクロホスファミド、サイトホスファン、シタラビン、フルオロウラシル、メルファラン、メトトレキサート、ウラムスチン、抗サイトカイン生物製剤、細胞受容体拮抗剤、細胞受容体類縁体、デキサメタゾン、プロゲステロン、ソマトスタチン、デキサメタゾンの類縁体、プロゲステロンの類縁体、ソマトスタチンの類縁体、テリパラチド、スコポラミン、抗高血圧薬、血圧降下調整薬、フェンタニル、クエン酸フェンタニル、モルヒネ、メペリジン、他のオピオイド類、アダリムマブ(抗組織壊死因子モノクローナル抗体又は抗TNF)、アナキンラ、ダクリズマブ、バシリキシマブ、アザチオプリン、シクロスポリン、タクロリムス、テストステロン、エストロゲン、成長ホルモン、インスリン、甲状腺ホルモン、卵胞刺激ホルモン(FSH)、エピネフリン/アドレナリン、ガンマ‐リノレン酸、ドコサヘキサエン酸、アラキドン酸、エイコサペンタエン酸、アモバルビタール、ペントバルビタール、セコバルビタール、フェノバルビタール、クロナゼパム、ジアゼパム、エスタゾラム、フルニトラゼパム、ロラゼパム、ミダゾラム、ニトラゼパム、オキサゼパム、トリアゾラム、テマゼパム、クロルジアゼポキシド、アルプラゾラム、アシュワガンダ、ピチュリ、キャットニップ、カバ(カワカワ)、マンドレイク、カノコソウ、マリファナ、エスゾピクロン、ザレプロン、ゾルピデム、ゾピクロン、ジフェンヒドラミン、ジメンヒドリナート、ドキシラミン、プロメタジン、抱水クロラール、ジシクロミン、アトロピン、臭化イプラトロピウム、臭化オキシトロピウム、チオトロピウム、レボドパ、ドーパミン、カルビドパ、ベンセラジド、コ‐セラルドパ、コ‐ベレルドパ、トルカポン、エンタカポン、ブロモクリプチン、ペルゴリド、プラミペキソール、ロピニロール、ピリベジル、カベルゴリン、アポモルフィン、リスリド、ヒト成長ホルモン、エリスロポエチン、ハロペリドール、ドロペリドール、クロルプロマジン、フルフェナジン、ペルフェナジン、プロクロルペラジン、チオリダジン、トリフルオペラジン、メソリダジン、ペリシアジン、プロマジン、トリフルプロマジン、レボメプロマジン、プロメタジン、ピモジド、クロルプロチキセン、クロペンチキソール、フルペンチキソール、チオチキセン、ズクロペンチキソール、クロザピン、オランザピン、リスペリドン、クエチアピン、ジプラシドン、アミスルプリド、アセナピン、パリペリドン、イロペリドン、ゾテピン、セルチンドール、アリピプラゾール、ビフェプルノックス、エタネルセプト、上記のうちの何れかの誘導体、及び上記のうちの何れかの組合せから選択される、請求項1に記載の注入システム。
- 前記危険有害性薬剤は、メトトレキサートである、請求項1に記載の注入システム。
- 前記動力駆動式注入器は、前記危険有害性薬剤の治療有効量を約4秒未満で注入するように構成されている、請求項1に記載の注入システム。
- 前記動力駆動式注入器は、前記危険有害性薬剤の治療有効量を約1秒で注入するように構成されている、請求項1に記載の注入システム。
- 前記動力駆動式注入器は、前記危険有害性薬剤を少なくとも毎秒約0.5mLの速度でジェット注入するように構成されているジェット注入器である、請求項1に記載の注入システム。
- 前記エネルギー源は、前記容器の中に少なくとも約300p.s.i.の圧力を生成するように構成されている、請求項6に記載の注入システム。
- 前記ジェット注入器は、針支援式ジェット注入器であり、前記注入出口部材は、患者の皮膚の外層を刺し、前記危険有害性薬剤をジェットとして前記患者の組織の中へ送達するように構成されている注入支援針を含んでいる、請求項6に記載の注入システム。
- 前記ジェット注入器は、針なしジェット注入器であり、前記注入出口部材は、針なしノズルを含んでおり、前記エネルギー源は、ジェット注入される前記危険有害性薬剤に患者の皮膚の外層を注入深さまで突き進ませるのに十分に強力である、請求項6に記載の注入システム。
- 前記危険有害性薬剤は、1ミリリットル当たり約7.5mgから約150mgの濃度にある、請求項1に記載の注入システム。
- 前記注入器は、事前充填済み単発注入器であり、
前記射出機構と前記エネルギー源は、メトトレキサートの単回限定発射を注入するように関係付けられ、構成されており、
前記注入器は、前記単回発射が注入された後に当該注入器がそれ以上注入を行うことができないようにする使用不能化機構を備えている、請求項3に記載の注入システム。 - 注入システムにおいて、
ジェット注入器であって、
危険有害性薬剤を収容するように構成されている容器と、
前記危険有害性薬剤を注入するための、前記容器と関係付けられている注入出口部材と、
前記危険有害性薬剤を注入するため、当該危険有害性薬剤を前記流体室から前記出口部材を通して押し出すように構成されている射出機構と、
前記危険有害性薬剤を前記注入出口からジェット注入する前記射出機構に動力供給するように当該射出機構と関係付けられているエネルギー源と、
前記射出機構を作動させるように当該射出機構と関係付けられているトリガ機構と、を備えるジェット注入器と、
前記容器に収容されている危険有害性薬剤の治療有効量と、を備えており、
前記ジェット注入器は、前記危険有害性薬剤の治療有効量を少なくとも毎秒約0.5mLの速度で注入するように構成されている、注入システム。 - 前記ジェット注入器は、前記危険有害性薬剤の治療有効量を約4秒未満で注入するように構成されている、請求項12に記載の注入システム。
- 前記ジェット注入器は、前記危険有害性薬剤の治療有効量を約1秒で注入するように構成されている、請求項12に記載の注入システム。
- 前記ジェット注入器は、針支援式ジェット注入器であり、前記注入出口部材は、患者の皮膚の外層を刺し、前記危険有害性薬剤をジェットとして前記患者の組織の中へ送達するように構成されている注入支援針を含んでいる、請求項12に記載の注入システム。
- 前記ジェット注入器は、針なしジェット注入器であり、前記注入出口部材は、針なしノズルを含んでおり、前記エネルギー源は、ジェット注入される前記危険有害性薬剤に患者の皮膚の外層を注入深さまで突き進ませるのに十分に強力である、請求項12に記載の注入システム。
- 前記危険有害性薬剤は、メトトレキサートである、請求項12に記載の注入システム。
- 炎症性疾患の治療のための注入システムにおいて、
ジェット注入器であって、
危険有害性薬剤を収容するように構成されている容器と、
前記危険有害性薬剤を注入するための、前記容器と関係付けられている注入出口部材と、
前記危険有害性薬剤を注入するため、当該危険有害性薬剤を前記流体室から前記出口部材を通して押し出すように構成されている射出機構と、
前記危険有害性薬剤を前記注入出口からジェット注入する前記射出機構に動力供給するように当該射出機構と関係付けられているエネルギー源と、
前記射出機構を作動させるように前記射出機構と関係付けられているトリガ機構と、を備えるジェット注入器と、
前記容器に収容されている危険有害性薬剤の治療有効量と、を備えていて、
前記危険有害性薬剤は、メトトレキサートを備え、当該メトトレキサートの治療有効量は、炎症性疾患を治療するのに十分であり、
前記ジェット注入器は、前記メトトレキサートの治療有効量を約5秒未満で注入するように構成されている、注入システム。 - 前記炎症性疾患は、関節リウマチである、請求項18に記載の注入システム。
- 前記ジェット注入器は、前記メトトレキサートの治療有効量を約4秒未満で注入するように構成されている、請求項18に記載の注入システム。
- 前記ジェット注入器は、前記メトトレキサートの治療有効量を約1秒で注入するように構成されている、請求項18に記載の注入システム。
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JP2016529052A (ja) * | 2013-09-09 | 2016-09-23 | エルテーエス ローマン テラピー−ジステーメ アーゲー | タンパク質の無針皮下投与 |
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JP2021104369A (ja) * | 2014-08-10 | 2021-07-26 | アンタレス・ファーマ・インコーポレーテッド | 注射装置で使用するためのシリンジ緩衝器 |
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JP2019150661A (ja) * | 2014-08-10 | 2019-09-12 | アンタレス・ファーマ・インコーポレーテッド | 注射装置で使用するためのシリンジ緩衝器 |
JP7150926B2 (ja) | 2014-08-10 | 2022-10-11 | アンタレス・ファーマ・インコーポレーテッド | 注射装置で使用するためのシリンジ緩衝器 |
JP7251762B2 (ja) | 2016-03-08 | 2023-04-04 | クロスジェクト | 改良された注射ノズルを装備した無針注射装置 |
JP2019507655A (ja) * | 2016-03-08 | 2019-03-22 | クロスジェクト | 改良された注射ノズルを装備した無針注射装置 |
KR20200139114A (ko) * | 2019-02-27 | 2020-12-11 | 종근당건강 주식회사 | 타라곤(Tarragon, Little Dragon, Mugwort, Estragon) 추출물을 함유하는 근육질환 예방 또는 치료용 조성물 |
KR102346511B1 (ko) | 2019-02-27 | 2022-01-03 | 종근당건강 주식회사 | 타라곤(Tarragon, Little Dragon, Mugwort, Estragon) 추출물을 함유하는 근육질환 예방 또는 치료용 조성물 |
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US20170043093A1 (en) | 2017-02-16 |
KR101597672B1 (ko) | 2016-02-25 |
US20150119799A1 (en) | 2015-04-30 |
US11497753B2 (en) | 2022-11-15 |
AU2010226442A1 (en) | 2011-10-13 |
KR20120028294A (ko) | 2012-03-22 |
JP2016104214A (ja) | 2016-06-09 |
US9750881B2 (en) | 2017-09-05 |
US20120157965A1 (en) | 2012-06-21 |
US20230104341A1 (en) | 2023-04-06 |
CA2755779A1 (en) | 2010-09-23 |
WO2010108116A1 (en) | 2010-09-23 |
JP5968976B2 (ja) | 2016-08-10 |
JP5732039B2 (ja) | 2015-06-10 |
US10555954B2 (en) | 2020-02-11 |
CN102612381B (zh) | 2015-09-09 |
JP2015042270A (ja) | 2015-03-05 |
EP2408493A1 (en) | 2012-01-25 |
CN102612381A (zh) | 2012-07-25 |
AU2010226442A2 (en) | 2011-10-13 |
US20170361021A1 (en) | 2017-12-21 |
US20130218086A1 (en) | 2013-08-22 |
US8579865B2 (en) | 2013-11-12 |
US20130030367A1 (en) | 2013-01-31 |
US8480631B2 (en) | 2013-07-09 |
US9421333B2 (en) | 2016-08-23 |
CA2755779C (en) | 2015-11-10 |
US8945063B2 (en) | 2015-02-03 |
US20200163975A1 (en) | 2020-05-28 |
US20140135303A1 (en) | 2014-05-15 |
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