JP2019512229A - 食事療法および運動での減量および心血管代謝の健康をさらに改善するための方法および組成物 - Google Patents
食事療法および運動での減量および心血管代謝の健康をさらに改善するための方法および組成物 Download PDFInfo
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Abstract
Description
本出願は、2016年3月7日付で出願された米国特許仮出願第62/304,783号;2016年4月12日付で出願された米国特許仮出願第62/321,727号;および2016年12月30日付で出願された米国特許仮出願第62/441,089号;の利益を主張するものであり、これらの各々はこの参照により本明細書に組み込まれる。
一部の実施形態では、該減量システムを行っている個体は、1回または複数回の食事を食事代替要素に置き換えている個体であり得る。一例において、食事代替要素はプロテインサプリメントを含むものであり得る。別の例では、食事代替要素は減量用シェイクであり得る。一例では、食事代替要素は、約20gのタンパク質、約3g〜約5gの脂肪、約16gの炭水化物、約2gのファイトステロールおよび約180カロリーを含むものであり得る。別の例では、食事代替要素は、約20gのタンパク質〜約60gのタンパク質、約3g〜約15gの脂肪、約32g〜約96gの炭水化物、約2g〜約4gのファイトステロールおよび約180〜約540カロリーを含むものであり得る。また別の例では、食事代替要素は、約40gのタンパク質、約6g〜約10gの脂肪、約32gの炭水化物、約4gのファイトステロールおよび約360カロリーを含むものであり得る。これはおよその食事の代替量であるが、同様に軽食のものとみなしてもよい。
一実施形態において、1日の最低タンパク質摂取量が約3ozであるカロリー制限食を食べており、1日約5,000歩に相当する日常身体活動を行っている被験体の減量を加速させる減量システムを提示する。該減量システムは、有効量の:抗菌成分;魚油;ラクトバチルス属の一種、ビフィドバクテリウム属の一種、ストレプトコッカス属の一種またはバチルス属の一種を含むプロバイオティクス成分;リンゴエキス、ブドウエキス、緑茶エキスおよびオリーブエキスを含む抗酸化ファイトケミカル成分;ならびにビタミンA、B、C、DおよびEを含むビタミン成分を含むものであり得る。該減量システムにより、被験体に投与しない場合より少なくとも3%大きく減量が刺激され得る。
この治験は、心血管代謝リスクファクターを有する概ね健康な体重過多の被験体における、食事療法およびライフスタイル改善(A群)と一群の減量刺激ダイエタリーサプリメントの投与を伴った同じ食事療法およびライフスタイル改善(B群)とを対比した2群無作為化非盲検試験であった。
InForm1.1の被験体Jは、実施例1に記載の健康的な体重および心血管代謝機能のためのプログラム(B群)に従い、表13に一覧にしたメタボリックシンドロームの診断基準の変化を有した。
の個別症例管理
被験体SAFは、実施例1に記載の健康的な体重および心血管代謝機能のためのInform1.1プログラム(B群)に従い、表14に一覧にしたメタボリックシンドロームの診断基準の変化を有した。
実施例1に記載のプログラムを、3カプセルのクルクミンBP/日を、実施例1で使用したBerberineIRの総分量約1,568mgの総クルクミイノイド(curcumiinoid)の代わりに使用して再度、行う。この代替により、健康、心血管代謝の変動および体重変動に対して実施例1に記載のものと同様のプラスの効果がもたらされる。
実施例1に記載のプログラムを、以下の変形:(1)治験は単群の観察試験にしたこと、(2)2回分量に分けた1,000mgのシナモンを999mgのベルベリンの代わりに使用したこと、ならびに(3)総分量約3〜90億cfu/日の1〜3カプセル/日のBacillus coagulansを、実施例1および4で使用したProbiotic 11の代わりに使用したことを伴って再度、行った。臨床プロトコルの全概要を表15に示す。食品プランは表5において前述のものであった。
表21および22は、それぞれ実施例1および5で使用したInForm1.1および1.2 PROGならびに対照食事療法の主要栄養素含有量を、1日分のカロリーに対するパーセントおよび1日あたりの主要栄養素のg数として示す。
Claims (97)
- 1日の最低タンパク質摂取量が約3ozであるカロリー制限食を食べており、かつ1日約5,000歩に相当する日常身体活動を行っている被験体の減量を加速させる減量システムであって、有効量の
ベルベリン、シナモン、クルクミン、またはそれらの組合せを含む抗菌成分と、
魚油と、
ラクトバチルス属、ビフィドバクテリウム属、バチルス属、およびストレプトコッカス属のうちの少なくとも1種類を含むプロバイオティクス成分と、
リンゴエキス、ブドウエキス、緑茶エキス、およびオリーブエキスを含む抗酸化ファイトケミカル成分と、
ビタミンA、B、C、D、およびEを含むビタミン成分と
を有し、減量システムは前記被験体に投与されない場合より少なくとも3%大きく減量を刺激する、減量システム。 - 請求項1に記載のシステムにおいて、前記カロリー制限食は、約1,250カロリー〜約1,500カロリーの1日の総カロリー摂取量を有する、システム。
- 請求項1に記載のシステムにおいて、カロリー制限食は、少なくとも1,350カロリーの1日の総カロリー摂取量を有する、システム。
- 請求項1に記載のシステムにおいて、前記1日の最低タンパク質摂取量は約12ozを有する、システム。
- 請求項1に記載のシステムにおいて、前記カロリー制限食は、
野菜約3カップ〜約6カップ分の1日の野菜摂取量、
1日5オンスの最低新鮮青物野菜摂取量、及び
1日48液量オンスの最低水分摂取量
を有する、システム。 - 請求項1に記載のシステムにおいて、前記カロリー制限食はさらに、1食分の果実または豆果の1日摂取量を有する、システム。
- 請求項1に記載のシステムにおいて、前記日常身体活動はさらに、前記被験体が1日あたり約115カロリー〜約300カロリーを消費する活動を週に5日行うことを有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分は約300mg〜約1,600mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はベルベリンを有し、前記ベルベリンは、インド産バーベリーの根であるBerberis aristataのエキスを有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はベルベリンを有し、前記ベルベリンは約999mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はシナモンを有し、前記シナモンはニッケイ属の1またはそれ以上の樹木種の内皮に由来する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はシナモンを有し、前記シナモンは約250mg〜約2,000mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はシナモンを有し、前記シナモンは約1,000mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分はクルクミンを有し、前記クルクミンは約1,500mg〜約1,600mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記魚油はアンチョビ、イワシ、およびサバに由来する油成分を有する、システム。
- 請求項1に記載のシステムにおいて、前記魚油は約1,000mg〜約3,000mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記魚油は約2,000mgの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はラクトバチルス属を有し、前記ラクトバチルス属は、L.rhamnosus、L.acidophilus、L.brevis、L.bulgaricus、L.plantarum、L.casei、L.salivarius、およびそれらの組合せからなる群から選択されるメンバーである、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はビフィドバクテリウム属を有し、前記ビフィドバクテリウム属は、B.bifidum、B.infantis、B.longum、およびそれらの組合せからなる群から選択されるメンバーである、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はバチルス属を有し、前記バチルス属はBacillus coagulansである、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はストレプトコッカス属を有し、前記ストレプトコッカス属はStreptococcus thermophilusである、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はさらに、イヌリン、フラクトオリゴ糖、プレバイオティクス食物繊維、およびそれらの組合せからなる群から選択されるメンバーを有する、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はプロバイオティクス約10億〜約500億コロニー形成単位(cfu)の1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はプロバイオティクス約360億cfuの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記プロバイオティクス成分はプロバイオティクス約30億〜約90億cfuの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記抗酸化ファイトケミカル成分中のリンゴ、ブドウ、緑茶、およびオリーブのエキスは、約1:1:1:1の重量比で存在する、システム。
- 請求項1に記載のシステムにおいて、前記抗酸化ファイトケミカル成分中のリンゴ、ブドウ、緑茶、およびオリーブのエキスは、約6:1:3:1の重量比で存在する、システム。
- 請求項1に記載のシステムにおいて、前記抗酸化ファイトケミカル成分はさらに、ブルーベリー濃縮物、トウガラシエキス、およびウコンエキスを有する、システム。
- 請求項25に記載のシステムにおいて、前記抗酸化ファイトケミカル成分はさらに、マンゴスチンの果皮エキスおよびベルガモットエキスを有する、システム。
- 請求項1に記載のシステムにおいて、前記抗酸化ファイトケミカル成分は約500mg〜約1,000mgの1日分量である、システム。
- 請求項1に記載のシステムにおいて、前記抗酸化ファイトケミカル成分は約750mgの1日分量である、システム。
- 請求項1に記載のシステムにおいて、前記ビタミン成分は、ビタミンB1、B2、B6、B12、およびそれらの組合せからなる群から選択されるビタミンB群を有する、システム。
- 請求項1に記載のシステムにおいて、前記ビタミン成分はビタミンD3を有する、システム。
- 請求項1に記載のシステムであって、さらに、鉄分、ドコサヘキサエン酸(DHA)、エイコサペンタエン酸(EPA)、カルシウム、ナイアシン、葉酸、ビオチン、パントテン酸、リン、ヨウ素、マグネシウム、亜鉛、セレン、銅、マンガン、クロム、カリウム、イノシトール、p−アミノ安息香酸(PABA)、コリン、重酒石酸塩、リコピン、ルテイン、抗酸化物質、タンポポの根、アルファルファの地上部、アスパラガスの茎、ブロッコリーの花序、キャベツの葉、ヘスペリジンバイオフラボノイドエキス、レモンのバイオフラボノイドエキス、ルチン、ローズヒップエキス、クロロフィル、昆布の葉と茎、クランベリー果実、マンゴスチン果実、ニンジン根、ホウレンソウの葉と茎、トマト果実、アサイーベリー、ザクロ果実エキス、I−ロイシン、I−リシン、I−バリン、I−イソルエシン、I−フェニアラニン、I−トレオニン、I−アルギニン、I−メチオニン、I−チロシン、I−システイン、およびそれらの組合せからなる群から選択されるメンバーを有する、システム。
- 請求項1に記載のシステムであって、さらに、所定量のファイトステロールを有する、システム。
- 請求項35に記載のシステムにおいて、前記ファイトステロールは約4gの1日分量を有する、システム。
- 請求項1に記載のシステムにおいて、前記カロリー制限食は食事代替処方食を有し、前記食事代替処方食は、約20gのタンパク質、約3g〜約5gの脂肪、約16gの炭水化物、および約2gのファイトステロールを有する、システム。
- 請求項1に記載のシステムにおいて、前記カロリー制限食は食事代替処方食を有し、前記食事代替処方食は、約20g〜約60gのタンパク質、約3g〜約15gの脂肪、約32g〜約96gの炭水化物、約2g〜約4gのファイトステロール、および約180〜約540カロリーを有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分、前記魚油成分、前記プロバイオティクス成分、前記抗酸化ファイトケミカル成分、および前記ビタミン成分は、経口処方剤中に存在する、システム。
- 請求項39に記載のシステムにおいて、前記経口処方剤は、液体、カプセル、粉末、またはバーの形態である、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分、魚油、プロバイオティクス成分、抗酸化ファイトケミカル成分、およびビタミン成分は、単一の処方剤中に存在する、システム。
- 請求項1に記載のシステムであって、さらに、認知行動プログラム要素を有する、システム。
- 請求項42に記載のシステムにおいて、前記認知行動プログラムは、マインドフルネス、ならびにストレス低減、リラクゼーション、および心身相関のためのビジュアリゼーション手法の教授に関する毎週のセミナーを有する、システム。
- 請求項1に記載のシステムにおいて、前記抗菌成分、魚油、プロバイオティクス成分、抗酸化ファイトケミカル成分、およびビタミン成分は、共処方剤中に存在する、システム。
- 請求項1に記載のシステムにおいて、前記システムは、前記被験体に、前記カロリー制限食を食べること、前記日常身体活動を行うこと、および前記減量システムを投与することの相加効果による量より多くの量の減量をもたらす、システム。
- 被験体の減量を促進する方法であって、被験体に、
ベルベリン、シナモン、クルクミン、またはそれらの組合せを含む有効量の抗菌成分と、
有効量の魚油と、
ラクトバチルス属、ビフィドバクテリウム属、バチルス属、およびストレプトコッカス属のうちの少なくとも1種類を含む有効量のプロバイオティクス成分と、
リンゴエキス、ブドウエキス、緑茶エキス、およびオリーブエキスを含む有効量の抗酸化ファイトケミカル成分と、
ビタミンA、B、C、D、およびEを含む有効量のビタミン成分と
を共投与する工程を有する、方法。 - 請求項46に記載の方法において、前記抗菌成分は前記被験体に約300mg〜約1,600mgの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記抗菌成分はベルベリンを有し、前記ベルベリンは前記被験体に約999mgの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記抗菌成分はシナモンを有し、前記シナモンは約1,000mgの1日分量を有する、方法。
- 請求項46に記載の方法において、前記抗菌成分は前記クルクミンを有し、前記クルクミンは前記被験体に約1,500mg〜約1,600mgの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記抗菌成分は前記被験体に1日3回投与される、方法。
- 請求項51に記載の方法において、前記抗菌成分は、朝食、昼食、および夕食とともに投与される、方法。
- 請求項46に記載の方法において、前記魚油は前記被験体に約1,000mg〜約2,000mgの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記魚油はさらに、エイコサペンタエン酸(EPA)及びドコサヘキサエン酸(DHA)を有し、前記10被験体に投与される前記EPAの1日分量は約760mgであり、前記被験体に投与されるDHAの1日分量は約380mgである、方法。
- 請求項46に記載の方法において、前記魚油は前記被験体に1日2回投与される、方法。
- 請求項46に記載の方法において、前記プロバイオティクス成分は前記被験体に約10億〜約500億コロニー形成単位(cfu)の1日分量で投与される、方法。
- 請求項46に記載の方法において、前記プロバイオティクス成分は前記被験体に約360億cfuの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記プロバイオティクス成分は前記被験体に約30億〜約90億cfuの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記プロバイオティクス成分は前記被験体に1日2回投与される、方法。
- 請求項46に記載の方法において、前記抗酸化ファイトケミカル成分は前記被験体に約500mg〜約1,000mgの1日分量で投与される、方法。
- 請求項46に記載の方法において、前記抗酸化ファイトケミカル成分は前記被験体に約750mgの1日分量で30投与される、方法。
- 請求項46に記載の方法において、前記抗酸化ファイトケミカル成分は前記被験体に夜に投与される、方法。
- 請求項46に記載の方法において、前記ビタミン成分は前記被験体に1日2回投与される、方法。
- 請求項46に記載の方法において、前記抗菌成分、前記魚油、前記プロバイオティクス成分、前記抗酸化ファイトケミカル成分、および前記ビタミン成分は、共処方剤で投与される、方法。
- 請求項46に記載の方法であって、さらに、前記被験体に食事代替処方食を投与する工程を有する、方法。
- 請求項65に記載の方法において、前記食事代替処方食は、朝食、昼食、および夕食のうちの少なくとも1回を置き換える、方法。
- 請求項65に記載の方法において、前記被験体に投与される前記食事代替処方食は、約20g〜約60gのタンパク質、約3g〜約15gの脂肪、約32g〜約96gの炭水化物、約2g〜約4gのファイトステロール、および約180〜約540カロリーを有する、方法。
- 請求項65に記載の方法において、前記被験体に投与される前記食事代替処方食は、約40gのタンパク質、約6g〜約10gの脂肪、約32gの炭水化物、約4gのファイトステロール、および約360カロリーを有する、方法。
- 請求項46に記載の方法であって、さらに、前記被験体が、カロリー制限食を摂取し、適度な身体活動を行い、かつ認知行動プログラムを行っていることを有する、方法。
- 請求項69に記載の方法において、前記カロリー制限食は、約1,250カロリー〜約1,500カロリーの1日の総カロリー摂取量を有する、方法。
- 請求項69に記載の方法において、前記カロリー制限食は、少なくとも1,350カロリーの1日の総カロリー5摂取量を有する、方法。
- 請求項69に記載の方法において、前記カロリー制限食は、12ozを有する1日の最低タンパク質摂取量を有する、方法。
- 請求項69に記載の方法において、前記カロリー制限食は、野菜約3カップ〜約6カップ分の1日の野菜摂取量、1日5オンスの最低新鮮青物野菜摂取量、および1日48液量オンスの最低水分摂取量を有する、方法。
- 請求項73に記載の方法において、前記カロリー制限食はさらに、1食分の果実または豆果の1日摂取量を有する、方法。
- 請求項69に記載の方法であって、さらに、前記被験体が、自身のカロリー制限食において、糖質、精製炭水化物、および穀類のうちの少なくとも1種類を制限することを有する、方法。
- 請求項69に記載の方法において、前記適度な身体活動は、前記被験体が、1日少なくとも5,000歩または1日に5,000歩相当、歩くことを有する、方法。
- 請求項76に記載の方法において、前記適度な身体活動はさらに、前記被験体が、約115カロリー〜約300カロリーを消費する活動を週に5日行うことを有する、方法。
- 請求項69に記載の方法において、前記認知行動プログラムは、マインドフルネス、ならびにストレス低減、リラクゼーション、および心身相関のためのビジュアリゼーション手法の教授に関する毎週のセミナーを有する、方法。
- 請求項46に記載の方法において、前記抗菌成分、前記魚油、前記プロバイオティクス成分、前記抗酸化ファイトケミカル成分、および前記ビタミン成分を前記被験体に投与する工程は、少なくとも12週間行われる、方法。
- 請求項79に記載の方法において、12週間後、前記被験体のうちの50%は12%の体重減少を体験する、方法。
- 請求項69に記載の方法において、前記方法は、前記被験体に、前記カロリー制限食を食べること、前記日常身体活動を行うこと、前記認知行動プログラムを行うこと、ならびに前記抗菌成分、魚油、プロバイオティクス成分、抗酸化ファイトケミカル成分、およびビタミン成分を共投与することの相加効果による量の減量より多くの量の減量をもたらす、方法。
- 減量プログラムに参加している被験体の健康状態を改善する方法であって、前記被験体に、
ベルベリン、シナモン、クルクミン、またはそれらの組合せを含む有効量の抗菌成分と、
有効量の魚油と、
ラクトバチルス属、ビフィドバクテリウム属、バチルス属、およびストレプトコッカス属のうちの少なくとも1種類を含む有効量のプロバイオティクス成分と、
リンゴエキス、ブドウエキス、緑茶エキス、およびオリーブエキスを含む有効量の抗酸化ファイトケミカル成分と、
ビタミンA、B、C、D、およびEを含む有効量のビタミン成分と
を共投与する工程を有する、方法。 - 請求項82に記載の方法において、前記抗菌成分、魚油、プロバイオティクス成分、抗酸化ファイトケミカル成分、およびビタミン成分を前記被験体に共投与する工程は、少なくとも12週間行われる、方法。
- 請求項82に記載の方法において、前記減量プログラムは、1日の最低タンパク質摂取量が少なくとも9ozのカロリー制限食、および1日少なくとも5,000歩に相当する日常身体活動を行うことを含む、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による降下より大きな血圧の降下を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による減少より多くの血中中性脂肪の減少を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による低下より大きなLDLコレステロールの低下を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による低下より大きな総コレステロールの低下を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による減少より多くの体脂肪量の減少を体験する、方法。
- 請求項89に記載の方法において、前記体脂肪量の減少が内臓脂肪量の減少である、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による修正より大きな腸内細菌叢の修正を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による修正より大きな腸内硝酸レベルの修正を体験する、方法。
- 請求項92に記載の方法において、前記腸内硝酸レベルの修正は一酸化窒素経路のモジュレーションによって行われる、方法。
- 請求項82に記載の方法において、前記被験体は、前記減量プログラム単独による改善より大きな心血管系、神経系、肺系、胃腸系、腎系、および免疫系のうちの少なくとも1つの機能の改善を体験する、方法。
- 請求項82に記載の方法において、前記被験体は、アルツハイマー病、狭心症、喘息、全身性鬱血性障害、クローン病、深部静脈血栓症、認知症、糖尿病(1、2および3型)、糖尿病性足病変、運動能力の低下、内皮機能不全、内毒素血症、勃起不全、線維筋痛症、糸球体腎炎、冠動脈疾患、心臓発作、心不全、高血圧、免疫不全、炎症性腸疾患、リーキーガット、黄斑変性、単球媒介性動脈プラーク形成、運動機能不全、LDLの酸化、歯周病、末梢動脈疾患、血小板粘着、門脈圧亢進症、妊娠/子癇前症、早漏、肺高血圧症、レイノー病、腎不全、睡眠時無呼吸、平滑筋細胞増殖、卒中、血管炎、ならびに皮膚関連の疾患、例えば遅い創傷治癒、しわ及び早期の加齢の徴候のうちの少なくとも1つに罹患しているか、または前記少なくとも1つを予防的に治療されている、方法。
- 請求項84に記載の方法において、前記抗菌成分、魚油、プロバイオティクス成分、抗酸化ファイトケミカル成分、およびビタミン成分を共投与すること、前記カロリー制限食を摂取すること、ならびに前記適度な身体活動を行うことは、肥満に関連する代謝異常の発生を予防する、方法。
- 請求項96に記載の方法において、前記肥満に関連する代謝異常は、アルツハイマー病、クローン病、糖尿病(1、2および3型)、運動能力の低下、内皮機能不全、内毒素血症、炎症性腸疾患、リーキーガット、LDLの酸化、および腎不全からなる群から選択されるメンバーである、方法。
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- 2017-03-06 CN CN201780027991.4A patent/CN109152400A/zh active Pending
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US20190261669A1 (en) | 2019-08-29 |
KR20190007412A (ko) | 2019-01-22 |
EP3426061A4 (en) | 2019-11-13 |
CN109152400A (zh) | 2019-01-04 |
US11122832B2 (en) | 2021-09-21 |
CA3016892A1 (en) | 2017-09-14 |
WO2017155898A1 (en) | 2017-09-14 |
EP3426061A1 (en) | 2019-01-16 |
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