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ORIGIN Trial and ORIGINALE Investigators Supplementary Tables Table S1. Baseline Characteristics of participants in the post-trial follow-up and eligible A-7 participants not included Table S2. Outcome events during the trial, during post-trial follow-up, and overall in A-8 the insulin glargine and standard care groups Table S3. Anthropometrics, blood pressure, A1C and creatinine during the trial and A-9 post-trial follow-up in the glargine study Table S4. Outcome events during the trial, during post-trial follow-up, and overall A-10 in the omega-3 and placebo groups Table S5. Medication use during the trial and post-trial follow-up in the omega-3 A-11 study Table S6. Anthropometrics, blood pressure, A1C and creatinine during the trial and A-12 post-trial follow-up in the omega-3 study Supplementary Figures Figure S1. Follow-up of study participants – insulin glargine vs. standard care A-13 Figure S2. Proportion of participants with events over time – glargine vs. standard care from randomization to the end of post-trial follow-up A-14 Figure S3. Forest Plot of Effect of Glargine on First Co-Primary Outcome by Key Subgroups from randomization to the end of post-trial follow-up A-15 Figure S4. Forest Plot of Effect of Glargine on Second Co-Primary Outcome by Key Subgroups from randomization to the end of post-trial follow-up A-16 Figure S5. Follow-up of participants – omega-3 vs. placebo A-17 Figure S6. Proportion of participants with events over time – omega-3 vs. placebo from randomization to the end of post-trial follow-up A-18 Figure S7. Forest Plot of Effect of Omega-3 on Cardiovascular Death by Key Subgroups from randomization to the end of post-trial follow-up A-19

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ORIGIN Trial and ORIGINALE Investigators Steering Committee H Gerstein (Co-chair and Co-PI), Z Punthakee (Co-chair and Co-PI), S Yusuf, L Rydén, K Birkeland, J Bosch (Project Director), E Cardona, P Commerford, G Dagenais, R Diaz, M Davies, G Fodor, R Gomis, M Hanefeld, P Hildebrandt, P Johnston, G Kacerovsky-Bielesz, M Keltai, F Lanas, BS Lewis, E Lonn, P López-Jaramillo, A Maggioni, J Marin-Neto, M Marre, R McKelvie, M McQueen, I Mendoza, C Morillo, C Pan, V Pīrāgs, J Probstfield, A Ramachandran, R Ratner, M Riddle, L Richardson (European Project Office), J Rosenstock, G.A Spinas, S Sreenan, M Syvänne, R Vige, JF Yale Global Project Office J Bosch, H Gerstein, H Jung, SF Lee, T Marsden, K Pohl, Z Punthakee, J Tyrwhitt, S Yusuf, E Zotova Site investigators by country Argentina: R Diaz, M Alzogiray, M Amuchastegui, M Bocahera, M Bustamante Labarta, B Bustos, A Caccavo, A Camino, M Cantero, L Cartasegna, R Chavez Cavauero, M Cipullo, G Costa, C Crespo, J Cuello, C Cuneo, C Dituro, A Dominquez, A Facta, A Ferrari, M Garrido, E Griot, N Gutierrez Carrillo, L Guzman, P Guzman, E Hasbani, R Henquin, M Hominal, V Illanes, H Imposti, M Lagrutta, P Lanchiotti, J Lowenstein, M Molina Dionigi, O Montana, M Mulazzi, M Pelagagge, A Prado, C Rodriguez, J Sala, A Sanchez, M Sicer, T Smith Casabella, L Soso, M Vico, V Visco, D Vogel, F Waisman, C Zaidman Australia: J Amerena, A Cheng, P Colman, D Colquhoun, M Kyi, A Nankervis, M So, G Soldatos, H Teede, L Williams Austria: G Kacerovsky-Bielesz, H Brath, H Drexel, K Ebner, F Hoppichler, T Kotter, E Kreuzwieser, R Prager, C Saely, A Said, K Steiner Bermuda: A West Brazil: J Marin-Neto, J Ayoub, C Barbosa, M Benes Teixeira Lemos, F Bittar, F Costa, O Costa Mouco, C Facanha, A Forti, A Franci, M Franken, R Furtado, F Lima, M Lima Filho, E Mattar, F Menezes, M NaKarone, J Nicolau, L Nigro Maia, R Sena Canada: G Dagenais, E Lonn, M Audet, E Auersperg, A Bailey, R Bhargava, M Boulianne, J Campeau, B Carlson, A Carpentier, J Cha, Y Chan, R Dumas, R Dupuis, D Eddy, D Eiley, G Gosselin, W Harper, I Hramiak, T Huynh, A Jacobson, C Lauzon, R Leader, H Lochnan, C McDonald, P Mehta , A Morisset, J Palardy, T Paul, G Pruneau, B Senay, D Shu, J Singh, A Skamene, D Steinson, R St-Hilaire, G Tsoukas, M Tsoukas, J Van Buuren, S Vizel, J Warnica, W Wong, V Woo, J Yale Chile: F Lanas, M Acevedo, F Lanas, G Larenas, P Pineda, P Varleta China: C Pan, J Ba, Y Bao, J Chen , Y Chen , P Feng, Z Feng, F Gao, X Guo, L Ji, W Jia, Q Li, F Liu, J Lu, Y Peng, Y Ren, Y Shao, H Tian, L Wang, S Yan, W Yang, Z Yang, X Yu, Z Yuan, L Zhao, B Zheng, H Zhou, D Zou Colombia: P Lopez-Jaramillo, J Accini, J Balaguera, C Cure, A Duarte, M Figueredo, J Gomez, E Hernandez, L Orozco, L Pava, M Perez, I Posada, A Quintero Baiz, F Quiroz, C Rendon, A Reyes, L Rodriguez, N Rodriguez, C Tibaduiza, M Urina, T Valencia, O Anderson

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Denmark: P Hildebrandt, L Baumbach, M Christiansen, K Clemmensen, K Egstrup, G Gislason, K Hansen, K Helleberg, P Jakobsen, J Jeppesen, T Krarup, T Krarup, B Linde, S Lund, S Madsbad, C Orskov, H Perrild, H Ronne, S Urhammer, K Vinther Finland: M Syvänne, H Haapamaki, A Kuusisto, J Makela, S Nieminen, J Ripatti, J Saltevo, K Savela, J Strand, T Valle France: M Marre, F Travert, G Charpentier, A Clergeot, V Kerlan , A Penfornis, C Petit, N Roudaut, B Schmitt, E Sonnet, F Travert Germany: M Hanefeld, T Bieler, U Bockmann, X Ganz, M Hanefeld, E Henkel, W Kamke, C Klein, A Kuehn, A Loew, C Marck, J Minnich, M Molkewehrum, I Muessig, W Pohl, F Schaper, P Schumm-Draeger, J Seissler, T Sgiet, T Siegmund, K Wilhelm Hungary: K Keltai, S Dolfos, G Farczadi, Z Gaal, K Hati, I Istenes, P Kempler, B Keresztes, Z Laszlo, G Nyirati, Z Papp, F Poor, Z Putz, A Somogyi, P Voros India: A Ramachandran, K Satheesh, M Ali, V Ayyar, M Badgandi, M Balaji, G Bantwal, S Kallur, S Kasthuri, P Manduva, V Mohan, A Muddana, D Naik, J Padoor, P Pais, R Patil, S Pedaprolu, S Pendsey, S Pendsey, S Poongothai, A Ramachandran, M Ramu, R Renikanur, K Satheesh, B Sethi, S Shetty, S Shetty, C Snehalatha, A Sosale, G Sridhar, N Thomas, B Vijayam Ireland: S Sreenan, S Abdulghafour, M Al Saeed, J Barton, A Costa Pozza, J Gibney, A Hameed, A Khattak, B Kinsley, K Mahmood, C McGurk, D O'Shea, M Osman Elfadil, S Sreenan, W Wan Mahmood Israel: S Lewis, R Abramof-Ness, M Becker, J Ben Aharon, A Beniashvilli, O Broudner, O Cohen, E Haddad, I Harman-Boehm, J Ilany, A Karasik, Y Khudyak, E Klainman, N Kogan-Nilsen, B Lewis, G Lieberman, L Michael, M Mosseri, M Omary, Y Rabkin, T Shuster, Y Turgeman, I Uri, D Zeltser, R Zimlichman Italy: A Maggioni, F Arturi, F Cacciatore, V Crippa, A Cutruzzola, A Falorni, G Filorizzo, G Furgi, I Gianluca, C Giorda, A Lapolla, V Minarelli, L Monti, L Moretti, M Palvarini, F Perticone, R Petacchi, F Piarulli, P Piatti, G Sesti, E Succurro, G Viviani Korea: S Chae, H Kim, J Son, J Woo, K Yoon Latvia: V Pirags, I Balcere, A Bumbere, K Ducena, R Ritenberga, S Steina Mexico: E Cardona, R Arechavaleta, T Beltran, C Calvo, E Cardona Munoz, A Contreras, S Del Muro Munoz, C Dominguez, J Gomez Carrasco, J Gonzalez, R Gonzalez, A Lopez, S Lozano, E Marquez Rodriguez, I Mendoza Mujica, S Pascoe Gonzalez, M Ruiz, E Velarde, R Velasco, M Vidrio Netherlands: E Badings, E Bruijns, P de Milliano, W Hermans, J Kooistra, J Langerveld, A Liem, D Lok, J Louwerenburg, P Nierop, H Roeters van Lennep, K Plomp , E Ronner, C van der Zwaan, J van Es, M Van Hessen, E Viergever Norway: K Birkeland, J Cooper, K Erichsen, C Fossum, E Gjertsen, R Joakimsen, K Risberg, S Skeie, H Smith, R Whitfield, J Winther, C Wium Philippines: M Abrahan, A Aguilar, E Catindig, F Lantion-Ang Poland: T Kawka-Urbanek, M Oberman, M Pawlowski, J Stecka-Wierzbicka, M Szpajer, J Zadrozny Russia: N Akhmedzhanov, A Ametov, B Bart, E Doskina, A Fokina, S Gilarevsky, V Gurevich, M Kalashnikova, Y Karpov, I Kochergina, I Kuparev, M Mikhailusova, D Nebieridze, N Petunina, A Safaryan, A Shubina, I Sinitsina, M Telnova, A Temirov, S Urazgildeeva, A Zilov

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Slovakia: G Fodor, J Bernatova, T Duris, P Minarik, K Raslova, B Vohnout South Africa: P Commerford, L Distiller, G Ellis, M Gani, C Kelbe, D Kelbe, N Levitt, R Moore, J Nel, H Nell, M Omar, M Pretorius, M Seeber, M Seeber, S Seedat, M Siebert, E Van Den Berg, M Van der Merwe, P Van Der Walt , F Van Niekerk, L Van Zyl, H Wellmann Sweden: L Rydén, P Albertsson, K Andersson, L Bengt, O Bergstrom, M Bjornstedt-Bennermo, J Blomgren, K Boman, K Christensen, P Enander, J Gil, P Hallgren, N Hellberg, L Henareh, J Holmqvist, S Jensen, L Jonasson, J Kalen, M Leosdottir, J Ljungberg, C Lysell-Bergstrom, U Mathiesen, L Mellbin, D Nathanson, B Nicolaisen, M Peterson, A Rosengren, L Ryden, K Svensson, A Tenerz, P Vasko Switzerland: G Spinas, M Braendle United Kingdom: M Davies, A Ali, P Banerjee, L Borthwick, C Dang, M Davies, R Donnelly, J Ewing, J Geraint, M Gibson, S Giritharan, I Iskandar, N Jackson, J Litchfield, N Malipatil, M Quinn, J Reckless, D Robertson, A Robinson, M Sampson, R Shenaz, I Tracey, A Viljoen, P Wiles USA: J Probstfield, M Riddle, A Ahmann, S Banarer, R Dudl, E Gillespie, M Hamaty, R Iverson, S Kaufman, B Klopfenstein, W Kniffen, S McFarlane, L Morris, P Niblack, L Olansky, K Osei, A Pandey, M Riddle, J Rosenstock, J Schnure, P Wu Venezuela: I Mendoza, I Brajkovich, E Carrillo, R Chacon, J Coll, K Gonzalez, D Marante, I Morr, D Perche, G Vergara, M Yolimar , y Study coordinators by count, #VALUE! Study coordinators by country Argentina: A Aviles, Y Benicelli, B Beritran, L Bowen, M Caceres, G Candali, A Capel, P Carrique, G Casaccia, C Ceirano, P Crunger, M Cuevas, M De Ferrariis, L Esposito, M Flenche, E Giozzi, M Hominal, M Ivana Elizabeth, Y Morell, A Navarro, V Novas, F Palma, M Rodera Vigil, M Takla, V Tinnirello, A Tristan, C Troncoso, C Venturini, S Vignau, M Vogel, S Zaidman Australia: B Batrouney, A Doran, K Fogarty, A Hulley, A Long, L Lynch, J Nairn, S Price-Smith, S Ryan Austria: Daemon, J Maiweg, B Patsch, B Rittmannsberger, D Zanolin Bermuda: Jones Brazil: N Codonho Goes, V Costa, A da Silva, O da Silva Junior, A Demore Martins, D Esteves, P Fabri, R Ferraz, M Forti, C Queirantes, M Tonani, A Vieira Canada: R Amche, T Anderlic, K Anderson, L Aro, S Badder, R Bakhet, B Barnabe, L Berard, C Boudreault, L Briol, M Brousseau, E Burke, S Chan, A Corfias, M Couture, D DeCurtis, P Droukas, A Dufour, P Dunn, D Eichmann, B Fox, S Gauthier, M Gourgues, S Joseph, S Kennedy, F Lapointe, A LeBlanc, A Lombardo, D Mallette, W McBeth, K Mehta, M Meilleur, B Miller, S Miner , L Morrow, M Naud, J Otis, F Ouimet, C Peck, L Perkins, F Poulin, K Primbas, B Roberge, M Roy, D Scarcelli, K Schellevis, N Schmidt, G Silverio, B Smith, C Stafford, C Stata, S Tereschyn, L Ullyatt, D Zaniol Chile: M Arau, J Hidalgo, I Padilla, F Toro China: J Lu, Y Ma, L Sun, H Wang, Y Yang Columbia: Y Ardila, O Bello, S Camargo, M Florez, V Fonseca, K Gomez M., M Gonzalez, R Jassir, K Pena, Y Ramirez, D Rodriguez Mejia, E Rojas, Y Samper, L Santamaria

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Denmark: M Bulow, A Frederiksen, A Frederiksen, B Hejlskov, S Jansen, S Jansen, A Jorgensen, M Lundgaard, A Meier, A Murrholm, B Nedergaard, D Norgaard, A Olsen, J Palmus , L Pedersen, D Raae, J Sandberg Madsen, U Sigsgaard, T Svaneborg, G Von Jessen, A Witt Finland: A Witt, R Heiskanen, J Liesivuori, L Lukkari-Kuronen, E Muurinen, P Nikkanen, A Nuojua, L Pekkonen, A Retsu, A Soppela France: M Feron Germany: C Boehm, G Bueschges, S Deigentasch, S Dietze, C Ernst, J Guerrero, D Holler, I Kraehe, P Kress, D Liebau-Matschke, B Matschke, B Schindlmeier, M Stahl, S Stricker, K Waetzold, M Willmerdinger, K Zenker, Hungary: E Gulyasne, M Herold, Z Nemeth, Z Zoltan Laszlo India: C Abraham, S Chalkhore, A Damodarachar, M Hussain, S Jayanthi, K Karkuzhali, V Koppikar, M Krishnamurthy, S Kumbar, J Mohammed, K Priyadharshini, K Purushothaman, G Ratan, N Ravendran, K Sankar, S Saundarya, S Singh, S Suresh, S Yasam Ireland: J Chong, A Conroy, M Courcy, E Donnelly, A Doyle, A Fitzgerald, G Hanlon, C Marmion, C Marmion, S McAteer, A McCarthy, O O'Grady, S Storey, H Vaughan Israel: S Arbeli, D Bar, E Biron, R Dvir, I Genin, C Langenauer, L Livshitz, I Orr, A Paster, S Pasternak, E Peer, N Platner, M Rosenvaser, H Saranga, M Segal, N Semionidi, S Steinmann, A Suleiman-Sawaed, Y Telner, E Tsirulnikov, K Uziez, R Yuval, S Zuker Italy: L Battaglia, M Cappiello, A Durante, S Macrina, E Nada, M Pugolotti, A Robusto, M Stuccillo, M Testa, R Toniato Korea: E Jang, Y Jeong, S Jung, S Lee Latvia: I Grigane Mexico: M Arenas, L Espitia, M Gonzalez, E Moran, E Padilla Netherlands: I Danse, J de Graauw, S de Greef, C de Jong, M Dirks, R Dommerholt, W Engelen, M Goddrie, J Havenaar, I Kort, H Kramer, G Reijnierse-Builenwerf, G van Buchem, M Van Buijsen, R van de Loo, M van der Knaap, M van der Zeijst, L Van Setten Van der Meer, H Verneij Norway: A Bakketun, S Coucheron, A Halsne, H Hansen, T Landbakk, A Larsen, S Moen, J Nilsen, E Orvik, B Sorgard, A Sorstrom, B Veiding, G Vinie Philippines: G Abquina, A Tamondong, L Vitug Poland: M Kolaczek, A Krainska Russia: A Safaryan, E Sakovich, N Zubovich Slovakia: Z Horynova, L Vankova South Africa: L Barnard, B Botha, S Britz, A de Waal, F Drummond, S Du Toit, T Ellis, M Engelbrecht, E Hodge, F Ismail, A Joubert, M Le Roux, K Mahomed, N Mngoma, A Moore, J Mostert, G Muller, E Nelson, A Nqipha, F Parker, M Roscher, E Scholtz, M Swartbooi, C Tredoux, N Tyumbu, J Van der Walt, J Van Dongen, G Van Wyngaard, H Wessels Sweden: I Akesson Jakobsson, M Andreasson, M Backlund, M Berglund, M Borjesson, E Brannestam, G Brolin, A Danielsson Frojd, A Duckert, K Eriksson, K Fehling, A Glaas, A Gustavsson, C Hage, K Hoglund, K Johansson, S Johansson, L Lundell, C Lundgren, K Magnusson, M Nilsson, M Ojutkangas, M Olofsson, C

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Olsson, U Pettersson, E Pramberg, M Quist, A Raschperger, U Sandberg, M Sjolin, M Soderlund, E Stensgaard, S Svard, A Svensson, H Tjerneld, E Torebo, I Uggeldahl, M Winther Resare Switzerland: M Gemperle, V Meyer-Lazzarini, E Riva, M Schefer, U Zinetti United Kingdom: M Appleby, A Barratt, J Bradley-Potts, C Brennan, L Bryan, D Campbell, B Dyson, M Fifield, J Fillary, Y Grimes, D Hall, J Howe, L Jones, R Kirkham, A McLenaghan, D Mills, L O'Donnell, C Phillips , J Thomas, G Whalley, S Willetts, S Yates United States of America: A Alam, A Anava, C Bogan, L Heil, B House, J Johnston, S Juben, P Keane-Richmond, L Lyons, K Marsh, R McCoy, A Mocanu, C Racine, M Roth, C Sagrilla, B Wollam Venezuela: I Mendoza, F Misticchio Tortorella, M Torres, H Urbaneja

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Supplementary Table S1. Baseline Characteristics of participants in the post-trial follow-up and eligible participants not included

Mean (SD) or Median [IQR] for skewed variables unless otherwise stated. * Participants completing the ORIGIN trial alive who themselves or whose sites declined post-trial follow-up or who were at sites with low or imbalanced recruitment into post-trial follow-up.

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Supplementary Table S2. Outcome events during the trial, during post-trial follow-up, and overall in the insulin glargine and standard care groups

Participants with recurrent events are counted only once in each column during which an event occurred. * Only proportions are reported as exact dates of these events were not collected during post-trial follow-up and time to event was not calculated. ** Excludes people with possible diabetes diagnosed during the ORIGIN trial.

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Supplementary Table S3. Anthropometrics, blood pressure, A1C and creatinine during the trial and post-trial follow-up in the glargine study

Mean (SD) or Median [IQR] for skewed variables. * Total number of participants at each stage.

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Supplementary Table S4. Outcome events during the trial, during post-trial follow-up, and overall in the omega-3 and placebo groups

Participants with recurrent events are counted only once in each column during which an event occurred.

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Supplementary Table S5. Medication use during the trial and post-trial follow-up in the omega-3 study

* Total number of consenting participants providing any medication history at each stage. Denominators for percentages in subsequent rows may be smaller. End of post-trial follow-up for omega-3 vs. placebo includes participants at sites with >80% follow-up for the omega-3 and placebo groups, and incompletely overlaps with sites for the insulin glargine vs. standard care comparison.

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Supplementary Table S6. Anthropometrics, blood pressure, A1C and creatinine during the trial and post-trial follow-up in the omega-3 study

Mean (SD) or Median [IQR] for skewed variables. * Total number of participants at each stage. End of post-trial follow-up for omega-3 vs. placebo includes participants at sites with >80% follow-up for the omega-3 and placebo groups, and incompletely overlaps with sites for the insulin glargine vs. standard care comparison.

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Supplementary Figure S1. Follow-up of study participants – insulin glargine vs. standard care. Participants followed until death or formal withdrawal. *Sites retaining <80% of surviving randomized participants in either the glargine or standard care groups for post-trial follow-up were excluded from the primary analysis but included in a sensitivity analysis. These sites only partially overlap with sites excluded from the omega-3 vs. placebo primary analysis for having <80% retention in those two groups. ** Includes trial data for all randomized participants.

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Supplementary Figure S2. Proportion of participants with events over time – glargine vs. standard care from randomization to the end of post-trial follow-up

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Supplementary Figure S3. Forest Plot of Effect of Glargine on First Co-Primary Outcome by Key Subgroups from randomization to the end of post-trial follow-up

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Supplementary Figure S4. Forest Plot of Effect of Glargine on Second Co-Primary Outcome by Key Subgroups from randomization to the end of post-trial follow-up

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Supplementary Figure S5. Follow-up of participants – omega-3 vs. placebo. Participants followed until death or formal withdrawal. *Sites retaining <80% of surviving randomized participants in either the omega-3 or placebo groups for post-trial follow-up were excluded from primary analysis but included in a sensitivity analysis. These sites only partially overlap with sites excluded from the insulin glargine vs. standard care primary analysis for having < 80% retention of those two groups. ** Includes trial data for all randomized participants.

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Supplementary Figure S6. Proportion of participants with events over time – omega-3 vs. placebo from randomization to the end of post-trial follow-up

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Supplementary Figure S7. Forest Plot of Effect of Omega-3 on Cardiovascular Death by Key Subgroups from randomization to the end of post-trial follow-up. Omega-3 Fatty Acid intake tertiles (mg/day): 0-73, 74-378, ≥379. Triglyceride tertiles (mmol/L); 0-1.28, 1.29-1.92, ≥1.93